What changed in this filing

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Item 1. Business

2021-06-14 compared with 2020-06-29 · 596 added, 808 removed, 162 unchanged (90% of the section changed)

ITEM 1 BUSINESS

Elite Pharmaceuticals,

Inc., a Nevada corporation (the “Company”, “Elite”, “Elite Pharmaceuticals”, the “registrant”,

“we”, “us”

or “our”) was incorporated on October 1, 1997 under the laws of the State of Delaware,

and its wholly-owned subsidiary, Elite Laboratories, Inc.

(“Elite Labs”), was incorporated on August 23, 1990 under

the laws of the State of Delaware.

On January 5, 2012, Elite Pharmaceuticals was reincorporated under the laws of the State of

We are a specialty

pharmaceutical company principally engaged in the development and manufacture of oral, controlled-release products, using proprietary

know-how and technology, particularly as it relates to abuse resistant products and the manufacture of generic pharmaceuticals.

Our strategy includes improving off-patent drug products for life cycle management, developing generic versions of controlled-release

drug products with high barriers to entry and the development of branded and generic products that utilize our proprietary and

patented abuse resistance technologies.

We occupy manufacturing,

warehouse, laboratory and office space at 165 Ludlow Avenue and 135 Ludlow Avenue in Northvale, NJ (the “Northvale Facility”).

The Northvale Facility operates under Current Good Manufacturing Practice (“cGMP”) and is a United States Drug Enforcement

Agency (“DEA”) registered facility for research, development and manufacturing.

We focus our efforts

on the following areas:

(i) manufacturing of a line of generic pharmaceutical products with approved Abbreviated New Drug Applications

(“ANDAs”);

Pharmaceuticals, Inc., a Nevada corporation (the “Company”, “Elite”, “Elite Pharmaceuticals”, the

“registrant”, “we”, “us”

or “our”) was incorporated on October 1, 1997 under the laws

of the State of Delaware, and its wholly-owned subsidiary, Elite Laboratories, Inc.

(“Elite Labs”), was incorporated on August

23, 1990 under the laws of the State of Delaware.

On January 5, 2012, Elite Pharmaceuticals was reincorporated under the laws of the

State of Nevada.

are a specialty pharmaceutical company principally engaged in the development and manufacture of oral, controlled-release generic products,

using proprietary know-how and technology.

Our strategy includes improving off-patent drug products for life cycle management, developing

generic versions of controlled-release drug products with high barriers to entry and exploiting our proprietary and patented abuse resistance

technologies.

occupy manufacturing, warehouse, laboratory and office space at 165 Ludlow Avenue and 135 Ludlow Avenue in Northvale, NJ (the “Northvale

Facility”).

The Northvale Facility operates under Current Good Manufacturing Practice (“cGMP”) and is a United States

Drug Enforcement Agency (“DEA”) registered facility for research, development and manufacturing.

focus our efforts on the following areas:

(i) manufacturing of a line of generic pharmaceutical products with approved Abbreviated New

Drug Applications (“ANDAs”);

(ii) development of additional generic pharmaceutical products;

(iii) development of the other products

in our pipeline including the products with our partners;

(iv) commercial exploitation of our products either by license and the

collection of royalties, or through the manufacture of our formulations;

and (v) development of new products and the expansion

of our licensing agreements with other pharmaceutical companies, including co-development projects, joint ventures and other collaborations.

Our focus is on the

development of various types of drug products, including branded drug products which require New Drug Applications (“NDAs”)

under Section 505(b)(1) or 505(b)(2) of the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Drug Price

Competition Act”) as well as generic drug products which require ANDAs.

We believe that our

business strategy enables us to reduce its risk by having a diverse product portfolio that includes both branded and generic products

(iii) development of the other

products in our pipeline including the products with our partners;

(iv) commercial exploitation of our products either by license and

the collection of royalties, or through the manufacture of our formulations;

and (v) development of new products and the expansion of

our licensing agreements with other pharmaceutical companies, including co-development projects, joint ventures and other collaborations.

focus is on the development of various types of drug products, including generic drug products which require ANDAs as well as branded

drug products which require New Drug Applications (“NDAs”) under Section 505(b)(1) or 505(b)(2) of the Drug Price Competition

and Patent Term Restoration Act of 1984 (the “Drug Price Competition Act”).

believe that our business strategy enables us to reduce its risk by having a diverse product portfolio that includes generic products

in various therapeutic categories and to build collaborations and establish licensing agreements with companies with greater resources

thereby allowing us to share costs of development and improve cash-flow.

Commercial Products

We own, license, contract

manufacture or receive royalties from the following products currently being sold commercially:

own, license, contract manufacture or receive royalties from the following products currently being sold commercially:

Product Equivalent

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Bontril ®

November 2012

HCl 15mg and 30mg capsules (“Phentermine 15mg”

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HCl 50mg tablets (“Naltrexone 50mg”)

September 2013

2.5mg and 5mg capsules (“Isradipine 2.5mg”

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Cardiovascular

Oxycodone HCl

Immediate Release 5mg, 10mg, 15mg, 20mg and 30mg tablets (“OXY IR 5mg”, “Oxy IR 10mg”, “Oxy

IR 15mg”, “OXY IR 20mg”

HCl Immediate Release 5mg, 10mg, 15mg, 20mg and 30mg tablets (“OXY IR 5mg”, “Oxy IR 10mg”, “Oxy IR

15mg”, “OXY IR 20mg”

and “Oxy IR 30mg”)

Roxycodone ®

Maleate Immediate Release 25mg, 50mg and 100mg capsules (“Trimipramine 25mg”, “Trimipramine 50mg”,

“Trimipramine 100mg”)

Maleate Immediate Release 25mg, 50mg and 100mg capsules (“Trimipramine 25mg”, “Trimipramine 50mg”, “Trimipramine

100mg”)

Surmontil ®

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Dextroamphetamine

Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Immediate Release 5mg, 7.5mg, 10mg, 12.5mg,

15mg, 20mg and 30mg tablets (“Amphetamine IR 5mg”, “Amphetamine IR 7.5mg”, “Amphetamine IR 10mg”,

“Amphetamine IR 12.5mg”, “Amphetamine IR 15mg”, “Amphetamine IR 20mg”

and “Amphetamine

IR 30mg”)

Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Immediate Release 5mg, 7.5mg, 10mg, 12.5mg, 15mg,

20mg and 30mg tablets (“Amphetamine IR 5mg”, “Amphetamine IR 7.5mg”, “Amphetamine IR 10mg”, “Amphetamine

IR 12.5mg”, “Amphetamine IR 15mg”, “Amphetamine IR 20mg”

and “Amphetamine IR 30mg”)

Adderall ®

Central Nervous System (“CNS”)

Nervous System (“CNS”) Stimulant

Sodium Capsules 25mg, 50mg and 100mg (“Dantrolene 25mg”, “Dantrolene 50mg”, Dantrolene 100mg”)

Dantrium ®

Muscle Relaxant

Dextroamphetamine

Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended Release 5mg, 10mg, 15mg, 20mg,

25mg, and 30mg capsules (“Amphetamine ER 5mg”, “Amphetamine ER 10mg”, “Amphetamine ER 15mg”,

“Amphetamine ER 20mg”, “Amphetamine ER 25mg”, and “Amphetamine ER 30mg”)

Adderall XR ®

Central Nervous System (“CNS”)

Phentermine 37.5mg is also referred

to as “Phentermine Tablets”.

Phentermine 15mg and Phentermine 30mg are collectively and individually referred to as

“Phentermine Capsules”.

Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended Release 5mg, 10mg, 15mg, 20mg, 25mg, and

30mg capsules (“Amphetamine ER 5mg”, “Amphetamine ER 10mg”, “Amphetamine ER 15mg”, “Amphetamine

ER 20mg”, “Amphetamine ER 25mg”, and “Amphetamine ER 30mg”)

Nervous System (“CNS”) Stimulant

Succinate 5mg, 10mg, 25mg and 50gm capsules (“Loxapine 5mg”, “Loxapine 10mg”, “Loxapine 25mg”,

and Loxapine 50mg”)

Loxapine ®

Antipsychotic

Phentermine 37.5mg is also referred to as “Phentermine Tablets”.

Phentermine 15mg and Phentermine 30mg are collectively and

individually referred to as “Phentermine Capsules”.

Phendimetrazine 35mg is also referred to as “Phendimetrazine Tablets”.

50mg is also referred to as “Naltrexone Tablets”.

Naltrexone 50mg is also referred to as “Naltrexone Tablets”.

Isradipine 2.5mg and Isradipine 5mg are collectively and individually

referred to as “Isradipine Capsules”.

Oxy IR 5mg, Oxy IR 10mg, Oxy IR 15mg Oxy IR 20mg and Oxy IR 30mg are collectively

and individually referred to as “Oxy IR”.

Trimipramine 25mg, Trimipramine 50mg, and Trimipramine 100mg are collectively

and individually referred to as “Trimipramine Capsules”.

Amphetamine IR 5mg, Amphetamine IR 7.5mg, Amphetamine IR

10mg, Amphetamine IR 12.5mg, Amphetamine IR 15mg, Amphetamine IR 20mg and Amphetamine IR 30mg are collectively and individually

referred to as “Amphetamine IR Tablets”.

Dantrolene 25mg, Dantrolene 50mg and Dantrolene 100mg are collectively and

individually referred to as “Dantrolene Capsules”.

Oxy IR 5mg, Oxy IR 10mg, Oxy IR 15mg Oxy IR 20mg and Oxy IR 30mg are collectively and

individually referred to as “Oxy IR”.

Trimipramine 25mg, Trimipramine 50mg, and Trimipramine 100mg are collectively and individually

referred to as “Trimipramine Capsules”.

Amphetamine IR 5mg, Amphetamine IR 7.5mg, Amphetamine IR 10mg, Amphetamine IR 12.5mg,

Amphetamine IR 15mg, Amphetamine IR 20mg and Amphetamine IR 30mg are collectively and individually referred to as “Amphetamine

IR Tablets”.

Dantrolene 25mg, Dantrolene 50mg and Dantrolene 100mg are collectively and individually referred to as “Dantrolene

Capsules”.

Amphetamine ER 5mg, Amphetamine ER 10mg, Amphetamine ER 15mg.

ER 20mg, Amphetamine ER 25mg and Amphetamine ER 30mg are collectively and individually referred to as “Amphetamine ER Capsules”.

The approved ANDA

for Phentermine 37.5mg was acquired pursuant to an asset purchase agreement with Epic Pharma LLC (“

Epic ”) dated

September 10, 2010 (the “

Amphetamine ER 20mg, Amphetamine ER 25mg and Amphetamine

ER 30mg are collectively and individually referred to as “Amphetamine ER Capsules”.

Loxapine 5gm, Loxapine 10mg, Loxapine

25mg and Loxapine 50mg are collectively and individually referred to as “Loxapine Capsules”.

approved ANDA for Phentermine 37.5mg was acquired pursuant to an asset purchase agreement with Epic Pharma LLC (“

Epic ”)

dated September 10, 2010 (the “

Phentermine Purchase Agreement ”).

Sales and marketing

rights for Phentermine 37.5mg are included in the licensing agreement between the Company and Precision Dose Inc.

and marketing rights for Phentermine 37.5mg are included in the licensing agreement between the Company and Precision Dose Inc.

Dose ”) dated September 10, 2010 (the “

Precision Dose License Agreement ”).

Please see the section

below titled “

Please see the section below titled

Precision Dose License Agreement ”

for further details of this agreement.

Phentermine 37.5mg

is currently being manufactured by Elite and distributed by TAGI under the Precision Dose License Agreement.

37.5mg is currently being manufactured by Elite and distributed by TAGI under the Precision Dose License Agreement.

Phendimetrazine

Tartrate 35mg

The ANDA for Phendimetrazine

was acquired by Elite in 2013.

Phendimetrazine 35mg

is currently a commercial product being manufactured at the Northvale Facility and distributed by Elite.

ANDA for Phendimetrazine was acquired by Elite in 2013.

Phendimetrazine

35mg is currently a commercial product being manufactured at the Northvale Facility and distributed by Elite.

15mg and Phentermine 30mg

Phentermine 15mg capsules

and Phentermine 30mg capsules were developed by the Company, with Elite receiving approval from the United States Food and Drug

Administration (“FDA”) of the related ANDA in September 2012.

Sales and marketing

rights for Phentermine 15mg and Phentermine 30mg are included in the Precision Dose License Agreement.

15mg capsules and Phentermine 30mg capsules were developed by the Company, with Elite receiving approval from the United States Food

and Drug Administration (“FDA”) of the related ANDA in September 2012.

and marketing rights for Phentermine 15mg and Phentermine 30mg are included in the Precision Dose License Agreement.

Please see the section

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for further details of this agreement.

Phentermine 15mg and

Phentermine 30mg are currently being manufactured by Elite and distributed by TAGI under the Precision Dose License Agreement.

Naltrexone 50mg

The ANDA for Naltrexone

50mg was acquired by Elite in 2010.

Sales and marketing

rights for Naltrexone 50mg are included in the Precision Dose License Agreement.

15mg and Phentermine 30mg are currently being manufactured by Elite and distributed by TAGI under the Precision Dose License Agreement.

ANDA for Naltrexone 50mg was acquired by Elite in 2010.

and marketing rights for Naltrexone 50mg are included in the Precision Dose License Agreement.

Please see the section below titled “

1 unchanged sentence

for further details of this agreement.

Naltrexone 50mg is currently being manufactured by Elite

and distributed by TAGI under the Precision Dose License Agreement.

Isradipine 2.5mg

and Isradipine 5mg

The approved ANDAs

for Isradipine 2.5mg and Isradipine 5mg were acquired by Elite in 2013

Isradipine 2.5mg and

Isradipine 5mg are currently a commercial product being manufactured by Elite at the Northvale Facility and distributed by Glenmark,

on an exclusive basis.

Oxycodone 5mg,

Oxycodone 10mg, Oxycodone 15mg, Oxycodone 20mg and Oxycodone 30mg (“Oxy IR”)

notification from Epic in October 2015 of the approval by the FDA of the ANDA for Oxy IR which is owned by Epic.

was an Identified IR Product in the Epic Strategic Alliance Agreement Dated March 18, 2009 (the “

Naltrexone 50mg is currently being manufactured by Elite and

distributed by TAGI under the Precision Dose License Agreement.

2.5mg and Isradipine 5mg

approved ANDAs for Isradipine 2.5mg and Isradipine 5mg were acquired by Elite in 2013

2.5mg and Isradipine 5mg are currently a commercial product being manufactured by Elite at the Northvale Facility and distributed by

Epic Pharma LLC (“Epic”), on an exclusive basis.

5mg, Oxycodone 10mg, Oxycodone 15mg, Oxycodone 20mg and Oxycodone 30mg (“Oxy IR”)

product was an Identified IR Product in the Epic Strategic Alliance Agreement Dated March 18, 2009 (the “

Epic Strategic Alliance ”).

Oxy IR was developed at the Northvale Facility pursuant to the Epic Strategic Alliance, in which we are entitled to a Product

Fee of 15% of Profits through March 2026, as defined in the Epic Strategic Alliance.

The first commercial sale of Oxy IR occurred

in March 2016, and sales by Epic of this product are ongoing.

Methods used by Epic in the manufacture of Oxy IR were developed at the Northvale Facility pursuant to the Epic Strategic Alliance, in

which we are entitled to a Product Fee of 15% of Profits through March 2026, as defined in the Epic Strategic Alliance.

The first commercial

sale of Oxy IR occurred in March 2016.

Epic has reported no profit or profit split for this product since September 2019.

25mg, Trimipramine 50mg and Trimipramine 100mg

The approved ANDA

for Trimipramine was acquired by Elite in 2017.

Trimipramine 25mg,

Trimipramine 50mg and Trimipramine 100mg are currently a commercial product being manufactured by Elite at the Northvale Facility

and distributed by Glenmark, on an exclusive basis.

On December 10, 2018,

the Company received approval from the FDA for Amphetamine IR Tablets, a generic version of Adderall ®

, an immediate-release

mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate,

Amphetamine Sulfate) with strengths of 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, and 30 mg tablets.

approved ANDA for Trimipramine was acquired by Elite in 2017.

25mg, Trimipramine 50mg and Trimipramine 100mg are currently a commercial product being manufactured by Elite at the Northvale Facility

and distributed by Epic, on an exclusive basis.

December 10, 2018, the Company received approval from the FDA for Amphetamine IR Tablets, a generic version of Adderall ®

an immediate-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine

Sulfate, Amphetamine Sulfate) with strengths of 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, and 30 mg tablets.

The product is a central

nervous system stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.

Amphetamine IR Tablets

are currently a commercial product being manufactured by Elite and distributed by Lannett Company Inc.

IR Tablets are currently a commercial product being manufactured by Elite and distributed by Lannett Company Inc.

(“Lannett”),

on an exclusive basis.

Dantrolene Capsules

The approved ANDAs

for Dantrolene 25mg, Dantrolene 50mg and Dantrolene 100mg were acquired by Elite in 2013.

Dantrolene Capsules are currently a

commercial product being manufactured by Elite at the Northvale Facility and distributed by Lannett, on an exclusive basis.

On December 12, 2019,

the Company received approval from the FDA for Amphetamine ER Capsules, a generic version of Adderall XR ®

, an extended-release

mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate,

Amphetamine Sulfate) with strengths of 5mg, 10mg, 15mg, 20mg, 25mg, and 30 mg tablets.

The product is a central nervous

system stimulant and is indicated for the treatment of ADHD and Narcolepsy.

Amphetamine ER Capsules

are currently a commercial product being manufactured by Elite and distributed by Lannett, on an exclusive basis.

Filed products under FDA review

approved ANDAs for Dantrolene 25mg, Dantrolene 50mg and Dantrolene 100mg were acquired by Elite in 2013.

Dantrolene Capsules are currently

a commercial product being manufactured by Elite at the Northvale Facility and distributed by Lannett, on an exclusive basis.

December 12, 2019, the Company received approval from the FDA for Amphetamine ER Capsules, a generic version of Adderall XR ®

an extended-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine

Sulfate, Amphetamine Sulfate) with strengths of 5mg, 10mg, 15mg, 20mg, 25mg, and 30 mg tablets.

The product is a central nervous system

stimulant and is indicated for the treatment of ADHD and Narcolepsy.

ER Capsules are currently a commercial product being manufactured by Elite and distributed by Lannett, on an exclusive basis.

approved ANDA for Loxapine was acquired by Elite in 2013.

Loxapine Succinate 5, 10, 25 and 50 mg are currently commercial products being

manufactured by Elite at the Northvale Facility, launched commercially in May 2021 and distributed by Burel Pharmaceuticals, Inc, an

affiliate of Prasco, LLC (“Burel”), on an exclusive basis.

products under FDA review

SequestOx™

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SequestOx™

our abuse-deterrent candidate for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.

is our abuse-deterrent candidate for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.

SequestOx™

is an immediate-release Oxycodone Hydrochloride containing sequestered Naltrexone which incorporates 5mg, 10mg,

15mg, 20mg and 30mg doses of oxycodone into capsules.

In January 2016, the

Company submitted a 505(b)(2) New Drug Application for SequestOx™, after receiving a waiver of the $2.3 million filing fee

from the FDA.

In March 2016, the Company received notification of the FDA’s acceptance of this filing and that such filing

has been granted priority review by the FDA with a target action under the Prescription Drug User Fee Act (“

is an immediate-release Oxycodone Hydrochloride containing sequestered Naltrexone which incorporates 5mg, 10mg, 15mg, 20mg and 30mg doses

of oxycodone into capsules.

January 2016, the Company submitted a 505(b)(2) New Drug Application for SequestOx™, after receiving a waiver of the $2.3 million

filing fee from the FDA.

In March 2016, the Company received notification of the FDA’s acceptance of this filing and that such

filing has been granted priority review by the FDA with a target action under the Prescription Drug User Fee Act (“

PDUFA ”)

of July 14, 2016.

On July 15, 2016,

the FDA issued a Complete Response Letter, or CRL, regarding the NDA.

July 15, 2016, the FDA issued a Complete Response Letter, or CRL, regarding the NDA.

The CRL stated that the review cycle for the SequestOx™

NDA is complete and the application is not ready for approval in its present form.

On July 7, 2017, the

Company reported topline results from a pivotal bioequivalence fed study for or SequestOx™.

The mean Tmax (the amount of

time that a drug is present at the maximum concentration in serum) of SequestOx TM was 4.6 hr.

with a range of 0.5 hr.

July 7, 2017, the Company reported topline results from a pivotal bioequivalence fed study for or SequestOx™.

The mean Tmax (the

amount of time that a drug is present at the maximum concentration in serum) of SequestOx TM was 4.6 hr.

with a range of 0.5

and the mean Tmax of the comparator, Roxicodone®, was 3.4 hr.

with a range of 0.5 hr.

A key objective

for the study was to determine if the reformulated SequestOx TM had a similar Tmax to the comparator when taken with

a high fat meal.

A key objective for

the study was to determine if the reformulated SequestOx TM had a similar Tmax to the comparator when taken with a high fat

Based on these results, the Company paused clinical trials for this formulation of SequestOx™.

30, 2018, the Company reported positive topline results from a pilot study conducted for a modified SequestOx™

based on the results of this pilot study, the modified SequestOx™

formulation is expected to achieve bioequivalence with

a Tmax range equivalent to the reference product when conducted in a pivotal trial under fed conditions.

The Company has provided

the pilot data to the FDA, requesting clarification as to the requirements for resubmission of the NDA.

The FDA has provided guidance

for repeated bio-equivalence studies in order to bridge the new formulation to the original SequestOx studies and also extended

our filing fee waiver until July 2020.

Due to the prohibitive cost of such repeated bio-equivalence studies, the Company has paused

development of this product.

There can be no assurances

of the Company conducting future clinical trials, or if such trials are conducted, there can be no assurances of the success of

any future clinical trials, or if such trials are successful, there can be no assurances that an intended future resubmission

On January 30, 2018, the Company

reported positive topline results from a pilot study conducted for a modified SequestOx™

wherein, based on the results of this

pilot study, the modified SequestOx™

formulation is expected to achieve bioequivalence with a Tmax range equivalent to the reference

product when conducted in a pivotal trial under fed conditions.

The FDA has provided guidance for repeated bio-equivalence studies in

order to bridge the new formulation to the original SequestOx™

studies and also extended our filing fee waiver until July 2020.

Due to the prohibitive cost of such repeated bio-equivalence studies, the Company has paused development of this product.

can be no assurances of the Company conducting future clinical trials, or if such trials are conducted, there can be no assurances of

the success of any future clinical trials, or if such trials are successful, there can be no assurances that an intended future resubmission

of the NDA product filing, if made, will be accepted by or receive marketing approval from the FDA.

In addition, even if marketing

authorization is received, there can be no assurances that there will be future revenues or profits, or that any such future revenues

or profits would be in amounts that provide adequate return on the significant investments made to secure this marketing authorization.

Oxycodone Hydrochloride

extended release (generic version of Oxycontin ®

On September 20, 2017,

the Company filed an ANDA with the FDA for generic version of Oxycontin®

In addition, even if marketing authorization

is received, there can be no assurances that there will be future revenues or profits, or that any such future revenues or profits would

be in amounts that provide adequate return on the significant investments made to secure this marketing authorization.

Hydrochloride extended release (generic version of Oxycontin ®

September 20, 2017, the Company filed an ANDA with the FDA for generic version of Oxycontin®

(extended release Oxycodone Hydrochloride).

OxyContin®

is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which

alternative treatment options are inadequate.

is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and

for which alternative treatment options are inadequate.

IMS reported approximately $2.3 billion in revenue for OxyContin®

and its equivalents

The FDA requested additional information relating to this filing, compliance with which would require significant resources.

Development of this product is currently paused, with the Company evaluating the feasibility of the continued development of this

Generic version

of an antibiotic product

On January 3, 2019,

the Company filed an ANDA with the FDA for a generic version of an antibiotic product.

equivalents in 2016.

The FDA requested additional information relating to this filing, compliance with which would require significant

Development of this product is currently paused, with the Company evaluating the feasibility of the continued development

of this product.

version of an antibiotic product

January 3, 2019, the Company filed an ANDA with the FDA for a generic version of an antibiotic product.

According to QVIA (formerly QuintilesIMS

Health) data, the branded product for this antibiotic and its equivalents had total annual U.S.

sales of approximately $85 million

for the twelve months ending September 30, 2019.

sales of approximately $85 million for

the twelve months ending September 30, 2019.

The product is jointly owned by Elite and SunGen Pharma LLC.

Upon approval by

the FDA of this ANDA, Elite will manufacture and package the product on a cost-plus basis.

The ANDA is currently under review

There can be no assurances

that any of these products will receive marketing authorization and achieve commercialization within this time period, or at all.

In addition, even if marketing authorization is received, there can be no assurances that there will be future revenues or profits,

or that any such future revenues or profits would be in amounts that provide adequate return on the significant investments made

to secure these marketing authorizations.

Approved Products Not Yet Commercialized

Loxapine 5mg,

10mg, 25mg and 50mg capsules (“Loxapine Capsules”)

The FDA approved a

transfer for manufacturing of Loxapine Capsules at the Northvale Facility.

The Company will provide an update upon launch of the

The approved ANDAs for Loxapine Capsules were acquired as part of the 2013 ANDA acquisition between the Company and Mikah

Please see the section below titled “Asset Acquisition Agreements”

for further details on the 2013 ANDA acquisition

There can be no assurances that there will be future revenues or profits, or that any such future revenues or profits

would be in amounts that provide adequate return on the significant investments made to secure these marketing authorizations.

Upon approval by the FDA of

this ANDA, Elite will manufacture and package the product on a cost-plus basis.

The ANDA is currently under review by the FDA.

can be no assurances that any of these products will receive marketing authorization and achieve commercialization within this time period,

In addition, even if marketing authorization is received, there can be no assurances that there will be future revenues or

profits, or that any such future revenues or profits would be in amounts that provide adequate return on the significant investments

made to secure these marketing authorizations.

Products Not Yet Commercialized

Acetaminophen

and Codeine Phosphate

The Company received

approval from the FDA of an ANDA for a generic version of Tylenol®

with Codeine (acetaminophen and codeine phosphate) 300mg/7.5mg,

300mg/15mg, 300mg/30mg and 300mg/60mg tablets.

Acetaminophen with codeine is a combination medication indicated for the management

of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate.

Acetaminophen

with codeine products have annual U.S.

sales of approximately $45 million according to IQVIA (formerly QuintilesIMS Health Data).

Company received approval from the FDA of an ANDA for a generic version of Tylenol®

with Codeine (acetaminophen and codeine phosphate)

300mg/7.5mg, 300mg/15mg, 300mg/30mg and 300mg/60mg tablets.

Acetaminophen with codeine is a combination medication indicated for

the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate.

Acetaminophen with codeine products have annual U.S.

sales of approximately $45 million according to IQVIA (formerly QuintilesIMS Health

The Company is not pursuing licensing deals for any opioids at this time until the market changes.

1 unchanged sentence

market to stabilize before pursuing these opportunities.

There can be no assurances

in relation to any of the above approved products not yet commercialized, that there will be future revenues of profits, or that

any such future revenues or profits would be in amounts that provide adequate return on the significant investments made to secure

these marketing authorizations.

Discontinued and Transferred Products

As part of standard

operating practices, the Company, from time to time, as relevant, conducts evaluations of all ANDAs owned, consisting, without

limitation, of ANDAs acquired or approved prior to the fiscal year ended March 31, 2020 (“Fiscal 2020”) and ANDAs

can be no assurances in relation to any of the above approved products not yet commercialized, that there will be future revenues of

profits, or that any such future revenues or profits would be in amounts that provide adequate return on the significant investments

made to secure these marketing authorizations.

and Transferred Products

part of standard operating practices, the Company, from time to time, as relevant, conducts evaluations of all ANDAs owned, consisting,

without limitation, of ANDAs acquired or approved prior to the fiscal year ended March 31, 2021 (“Fiscal 2021”) and ANDAs

acquired or approved during the Fiscal 2021.

Such evaluations include, without limitation, costs and benefits relating to each

ANDA owned, with such costs including those fees required under the FDA’s Generic Drug User Fee Amendment (“GDUFA”)

which is significantly influenced by the number of ANDAs owned, and other costs and benefits taking into consideration various

specific market factors for each ANDA.

Those ANDAs with a cost/benefit profile not consistent with management criteria for continuation

are identified for disposition and effort is made to determine the optimal course of action to achieve disposition of the ANDA.

During Fiscal 2020,

approved ANDAs for the following products were identified for disposition and transferred to third parties in exchange for cash

consideration received:

- Methadone 5mg and 10mg tablets (“Methadone

Tablets”)

- Phendimetrazine 35mg tablets (the

“Second Phendimetrazine Product”)

- Hydromorphone 8mg tablets (“Hydromorphone

Tablets”)

- Oxycodone and Acetaminophen 5mg/325mg,

7.5mg/325mg, 10mg/325mg tablets (“Oxycodone and Acetaminophen Tablets”)

- Hydrocodone and Acetaminophen 2.5mg/325mg,

5mg/325mg, 7.5mg/325mg, 10mg/325mg tablets (“Hydrocodone and Acetaminophen Tablets”)

Methadone 5mg and 10mg tablets

The Approved ANDA

for Methadone 5mg and 10mg tablets was sold to Nostrum Laboratories Inc.

(“Nostrum”) for cash consideration totaling

$300,000 in February 2020.

This ANDA was developed by Elite prior to Fiscal 2020, with the costs of such development being charged

against income in the periods incurred.

The sale of this ANDA resulted in the recognition of other income during Fiscal 2020 in

an amount equal to the cash consideration received.

Phendimetrazine 35mg tablets

The Approved ANDA

for Phendimetrazine 35mg tablets was sold to Nostrum for cash consideration totaling $300,000 in February 2020.

This ANDA was

developed by Elite prior to Fiscal 2020, with the costs of such development being charged against income in the periods incurred.

The sale of this ANDA resulted in the recognition of other income during Fiscal 2020 in an amount equal to the cash consideration

Please note that,

at the time of this transaction, the Company had two approved ANDAs for phendimetrazine 35mg tablets.

After selling one of these

ANDAs, the Company retained one approved ANDA for this product, with this ANDA being included in current commercial operations.

Please see the section above titled “Commercial Products”

for more details on the ANDA retained.

Hydromorphone 8mg tablets

The Approved ANDA

for Hydromorphone 8mg tablets was sold to Nostrum for cash consideration totaling $300,000 in December 2019.

This ANDA had a

book value of zero at the time of its sale to Nostrum.

The sale of this ANDA resulted in the recognition of other income during

Fiscal 2020 in an amount equal to the cash consideration received.

Oxycodone and Acetaminophen 5mg/325mg,

7.5mg/325mg, 10mg/325mg tablets

The Approved ANDA

for Oxycodone and Acetaminophen 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets was sold to Nostrum for cash consideration totaling

$300,000 in November 2019.

This ANDA was developed by Elite prior to Fiscal 2020, with the costs of such development being charged

against income in the periods incurred.

The sale of this ANDA resulted in the recognition of other income during Fiscal 2020 in

an amount equal to the cash consideration received.

Hydrocodone and Acetaminophen 2.5mg/325mg,

5mg/325mg, 7.5mg/325mg, 10mg/325mg tablets

The Approved ANDA

for Hydrocodone and Acetaminophen 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets was sold to Nostrum for cash consideration

totaling $300,000 in November 2019.

This ANDA was developed by Elite prior to Fiscal 2020, with the costs of such development

being charged against income in the periods incurred.

The sale of this ANDA resulted in the recognition of other income during

Fiscal 2020 in an amount equal to the cash consideration received.

Licensing, Manufacturing and Development

Sales and Distribution

Licensing Agreement with Epic Pharma LLC for SequestOx™

On June 4, 2015, we

executed an exclusive License Agreement (the “

Such evaluations include, without limitation, costs and benefits relating to each ANDA owned,

with such costs including those fees required under the FDA’s Generic Drug User Fee Amendment (“GDUFA”) which is significantly

influenced by the number of ANDAs owned, and other costs and benefits taking into consideration various specific market factors for each

Those ANDAs with a cost/benefit profile not consistent with management criteria for continuation are identified for disposition

and effort is made to determine the optimal course of action to achieve disposition of the ANDA.

Manufacturing and Development Agreements

and Distribution Licensing Agreement with Epic Pharma LLC for SequestOx™

June 4, 2015, we executed an exclusive License Agreement (the “

2015 SequestOx™

License Agreement ”) with Epic, to market

and sell in the U.S., SequestOx™, an immediate release oxycodone with sequestered naltrexone capsule, owned by us.

will have the exclusive right to market ELI-200 and its various dosage forms as listed in Schedule A of the Agreement.

responsible for all regulatory and pharmacovigilance matters related to the products.

Pursuant to the 2015 SequestOx™

Agreement, Epic will pay us non-refundable milestone payments totaling $15 million, with such amount representing the cost of

an exclusive license to SequestOx™, the cost of developing the product, the filing of an NDA with the FDA and the receipt

of the approval letter for the NDA from the FDA.

The 2015 SequestOx™

License Agreement ”) with Epic,

to market and sell in the U.S., SequestOx™, an immediate release oxycodone with sequestered naltrexone capsule, owned by us.

2015 SequestOx ™

License Agreement expired on June 4, 2020.

the term of this agreement, the Company received $7.5 million in non-refundable payments, with such amount consisting of $5 million

due and owing on the execution date of the 2015 SequestOx™

License Agreement and $2.5 million being earned upon the

Company’s filing of an NDA with the FDA for the relevant product in January 2016.

The remaining $7.5 million in non-refundable

payments required FDA approval of the relevant product, a milestone that was not achieved prior to the expiration of the agreement.

Precision Dose

License Agreement

On September 10, 2010,

we executed a License Agreement with Precision Dose (the “

Precision Dose License Agreement ”) to market and

distribute Phentermine 37.5mg, Phentermine 15mg, Phentermine 30mg, Hydromorphone 8mg, Naltrexone 50mg, and certain additional

products that require approval from the FDA, through its wholly-owned subsidiary, TAGI, in the United States, Puerto Rico and

During the term of this agreement, the Company received $7.5

million in non-refundable payments, with such amount consisting of $5 million due and owing on the execution date of the 2015 SequestOx™

License Agreement and $2.5 million being earned upon the Company’s filing of an NDA with the FDA for the relevant product in

January 2016.

The remaining $7.5 million in non-refundable payments required FDA approval of the relevant product, a milestone that was

not achieved prior to the expiration of the agreement.

Dose License Agreement

September 10, 2010, we executed a License Agreement with Precision Dose (the “

Precision Dose License Agreement ”) to

market and distribute Phentermine 37.5mg, Phentermine 15mg, Phentermine 30mg, Hydromorphone 8mg, Naltrexone 50mg, and certain additional

products that require approval from the FDA, through its wholly-owned subsidiary, TAGI, in the United States, Puerto Rico and Canada.

Phentermine 37.5mg was launched in April 2011.

Hydromorphone 8mg was launched in March 2012.

Phentermine 15mg and Phentermine

30mg were launched in April 2013.

Phentermine 15mg and Phentermine 30mg were

launched in April 2013.

Naltrexone 50mg was launched in September 2013.

Precision Dose will have the exclusive right

to market these products in the United States and Puerto Rico and a non-exclusive right to market the products in Canada.

Pursuant to the Precision

Dose License Agreement, Elite will receive a license fee and milestone payments.

The license fee will be computed as a percentage

of the gross profit, as defined in the Precision Dose License Agreement, earned by Precision Dose as a result of sales of the

Precision Dose will have the exclusive right to market these

products in the United States and Puerto Rico and a non-exclusive right to market the products in Canada.

to the Precision Dose License Agreement, Elite will receive a license fee and milestone payments.

The license fee will be computed as

a percentage of the gross profit, as defined in the Precision Dose License Agreement, earned by Precision Dose as a result of sales of

the products.

The license fee is payable monthly for the term of the Precision Dose License Agreement.

The milestone payments will

be paid in six instalments.

The milestone payments will be

paid in six instalments.

The first instalment was paid upon execution of the Precision Dose License Agreement.

The remaining

instalments are to be paid upon FDA approval and initial shipment of the products to Precision Dose.

The term of the Precision

Dose License Agreement is 15 years and may be extended for 3 successive terms, each of 5 years.

Master Development

and License Agreement with SunGen Pharma LLC

On August 24, 2016,

as amended we entered into an agreement with SunGen Pharma LLC (“SunGen”) (the “SunGen Agreement”) to

undertake and engage in the research, development, sales and marketing of eight generic pharmaceutical products.

The remaining instalments

are to be paid upon FDA approval and initial shipment of the products to Precision Dose.

The term of the Precision Dose License Agreement

is 15 years and may be extended for three successive terms, each of five years.

Development and License Agreement with SunGen Pharma LLC

August 24, 2016, as amended we entered into an agreement with SunGen Pharma LLC (“SunGen”) (the “SunGen Agreement”)

to undertake and engage in the research, development, sales and marketing of eight generic pharmaceutical products.

Two of the products

are classified as CNS stimulants (the “CNS Products”), two of the products are classified as beta blockers and the

remaining four products consist of antidepressants, antibiotics and antispasmodics.

The Company has received approval from the

FDA for Amphetamine IR Tablets, Amphetamine ER Capsules and has filed an ANDA for an antibiotic product.

Under the terms of

the SunGen Agreement, Elite and SunGen will share in the responsibilities and costs in the development of these products and will

share substantially in the profits from sales.

Upon approval, the know-how and intellectual property rights to the products will

be owned jointly by Elite and SunGen.

are classified as CNS stimulants (the “CNS Products”), two of the products are classified as beta blockers and the remaining

four products consist of antidepressants, antibiotics and antispasmodics.

The Company has received approval from the FDA for Amphetamine

IR Tablets, Amphetamine ER Capsules and has filed an ANDA for an antibiotic product.

the terms of the SunGen Agreement, Elite and SunGen will share in the responsibilities and costs in the development of these products

and will share substantially in the profits from sales.

Upon approval, the know-how and intellectual property rights to the products

will be owned jointly by Elite and SunGen.

Three of the eight products will be jointly owned, three products will be owned by SunGen,

with Elite having exclusive marketing rights and the remaining two products will be owned by Elite, with SunGen having exclusive

marketing rights.

with Elite having exclusive marketing rights and the remaining two products will be owned by Elite, with SunGen having exclusive marketing

Elite will manufacture and package all eight products on a cost-plus basis.

10, 2018, the Company received approval from the FDA for Amphetamine IR Tablets, a generic version of Adderall ®

December 10, 2018, the Company received approval from the FDA for Amphetamine IR Tablets, a generic version of Adderall ®

an immediate-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine

Sulfate, Amphetamine Sulfate) with strengths of 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, and 30 mg tablets.

is a central nervous system stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and

The product is jointly owned by Elite and SunGen.

Elite manufactures and packages this product, at the

Northvale Facility, on a cost-plus basis, and it is currently sold pursuant to the Lannett Alliance, with the first commercial

shipment of this product occurring in April 2019.

Please see the section below titled “Strategic Marketing Alliance with

Lannett Company Inc.”

for further details on the Lannett Alliance

On January 3, 2019,

the Company filed an ANDA with the FDA for a generic version of an antibiotic product.

The product is a central

nervous system stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.

is jointly owned by Elite and SunGen.

Elite manufactures and packages this product, at the Northvale Facility, on a cost-plus basis,

and it is currently sold pursuant to the Lannett Alliance, with the first commercial shipment of this product occurring in April 2019.

Please see the section below titled “Strategic Marketing Alliance with Lannett Company Inc.”

for further details on the Lannett

January 3, 2019, the Company filed an ANDA with the FDA for a generic version of an antibiotic product.

According to QVIA (formerly QuintilesIMS

Health) data, the branded product for this antibiotic and its equivalents had total annual U.S.

sales of approximately $94 million

for the twelve months ending September 30, 2018.

sales of approximately $94 million for

the twelve months ending September 30, 2018.

The product is jointly owned by Elite and SunGen.

Upon approval by the FDA of

this ANDA, Elite will manufacture and package the product on a cost-plus basis.

Upon approval by the FDA of this ANDA,

Elite will manufacture and package the product on a cost-plus basis.

The ANDA is currently under review by the FDA.

On December 12, 2019,

the Company received approval from the FDA for Amphetamine ER Capsules, a generic version of Adderall XR ®

, an extended-release

mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate,

Amphetamine Sulfate) with strengths of 5mg, 10mg, 15mg, 20mg, 25mg and 30mg capsules.

December 12, 2019, the Company received approval from the FDA for Amphetamine ER Capsules, a generic version of Adderall XR ®

an extended-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine

Sulfate, Amphetamine Sulfate) with strengths of 5mg, 10mg, 15mg, 20mg, 25mg and 30mg capsules.

The product is a central nervous system

stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The product is jointly owned

by Elite and SunGen.

Elite manufactures and packages this product, at the Northvale Facility, on a cost plus basis and it is currently

sold pursuant to the Lannett Alliance, with the first commercial shipment of this product occurring in March 2020.

the section below titled “Strategic Marketing Alliance with Lannett Company Inc.”

for further details on the Lannett

On April 3, 2020,

Elite and SunGen mutually agreed to discontinue any further joint product development activities under the SunGen Agreement.

In May 2020, SunGen,

under an asset purchase agreement, assigned its rights and obligations under the SunGen Agreement for Amphetamine IR and Amphetamine

ER to Mikah Pharmaceuticals.

The product is jointly owned by

Elite and SunGen.

Elite manufactures and packages this product, at the Northvale Facility, on a cost plus basis and it is currently sold

pursuant to the Lannett Alliance, with the first commercial shipment of this product occurring in March 2020.

Please see the section

below titled “Strategic Marketing Alliance with Lannett Company Inc.”

for further details on the Lannett Alliance.

April 3, 2020, Elite and SunGen mutually agreed to discontinue any further joint product development activities under the SunGen Agreement

except for the antibiotic tablet product which has been filed with the FDA and the antibiotic capsule product not yet filed.

products remain jointly owned assets of the parties.

May 2020, SunGen, under an asset purchase agreement, assigned its rights and obligations under the SunGen Agreement for Amphetamine IR

and Amphetamine ER to Mikah Pharmaceuticals.

The ANDAs for Amphetamine IR and Amphetamine ER are now registered under Elite’s name.

will now be Elite’s partner with respect to Amphetamine IR and ER and will assume all the rights and obligations for these

Mikah will now be Elite’s partner with respect to Amphetamine IR and ER and will assume all the rights and obligations for these

products from SunGen.

There can be no assurances

that any of these products will receive marketing authorization and achieve commercialization within this time period, or at all.

In addition, even if marketing authorization is received, and even for those products for which marketing authorization has already

been received, there can be no assurances that there will be future revenues or profits, or that any such future revenues or profits

would be in amounts that provide adequate return on the significant investments made to secure these marketing authorizations

can be no assurances that any of these products will receive marketing authorization and achieve commercialization within this time period,

In addition, even if marketing authorization is received, and even for those products for which marketing authorization has

already been received, there can be no assurances that there will be future revenues or profits, or that any such future revenues or

profits would be in amounts that provide adequate return on the significant investments made to secure these marketing authorizations

or provide sufficient financial contributions to support costs of operations and overheads.

Strategic Marketing

Alliance with Glenmark Pharmaceuticals, Inc.

On May 22, 2018, and

as amended on August 1, 2018, we entered into a license, manufacturing and supply agreement with Glenmark Pharmaceuticals Inc.

Marketing Alliance with Glenmark Pharmaceuticals, Inc.

May 22, 2018, and as amended on August 1, 2018, we entered into a license, manufacturing and supply agreement with Glenmark Pharmaceuticals

Glenmark ”) to market the two Elite generic products described below in the United States with the option

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Glenmark Alliance ”).

Pursuant to the Glenmark

Alliance, Glenmark will purchase the products from Elite and then sell and distribute them.

In addition to the purchase prices

for the products, Elite will receive license fees well in excess of 50% of gross profits.

Gross profits are defined as net sales

less the price paid to Elite for the products, distribution fees (less than 10%) and shipping costs.

Glenmark will have

semi-exclusive marketing rights to the ANDA approved generic product, phendimetrazine 35mg tablets, and exclusive marketing rights

to the following ANDA approved generic products:

Methadone 10mg, Methadone 5mg, Trimipramine 25mg, Trimipramine 50mg, Trimipramine

100mg, and, effective October 2, 2018, upon expiration of the Epic Manufacturing and License Agreement, exclusive marketing rights

to the following ANDA approved generic products:

Isradipine 2.5mg and Isradipine 5mg.

The Glenmark Alliance has an initial term

of three years and automatically renews for one year periods absent prior written notice of non-renewal.

In addition to customary

termination provisions, the Agreement permits Glenmark to terminate with regard to a product on at least three months’

written notice if it determines to stop marketing and selling such product, and it permits Elite to terminate with regard to a

product if at any time after the first twelvemonths from the first commercial sale, the average license fee paid by Glenmark for

such product is less than $100,000 for a six month sales period.

The first commercial

shipment of Methadone Tablets pursuant to the Glenmark Alliance occurred in November 2018.

The first commercial shipment of Isradipine

Capsules pursuant to the Glenmark Alliance occurred in March 2019.

The first commercial shipment of Trimipramine Capsules occurred

in April 2019.

The Methadone license was terminated in October 2019 and the Phendimetrazine license was terminated in February

Both products have subsequently been divested (see “Discontinued and Transferred Products”

There can be no assurances

that there will be future revenues of profits, earned pursuant to the Glenmark Alliance, or that any such future revenues or profits

would be in amounts that provide adequate return on the significant investments made to secure the marketing authorizations for

products included in the Glenmark Alliance or provide sufficient financial contributions to support costs of operations and overheads.

Strategic Marketing

Alliances with Lannett Company Inc

The Company has entered

into two separate license, supply and distribution agreements with Lannett Company Inc.

The license for Methadone Tablets was terminated by mutual

agreement in December 2019.

The license for Phendimetrazine Capsules was terminated by mutual agreement in February 2020.

for Trimipramine Capsules and Isradipine Capsules expired in May 2021.

the term of the Glenmark Alliance, Glenmark had exclusive marketing rights to the following products:

Methadone Tablets, Trimipramine

Capsules and Isradipine Capsules.

Glenmark also had semi-exclusive marketing rights to Phendimetrazine Tablets.

All products included

in the Glenmark Alliance were manufactured by Elite.

In addition to the purchase prices for the products, Elite also received license

fees in excess of 50% of gross profits, with such being defined as net sales less the price paid to Elite for the products, distribution

fees of less than 10% and shipping costs.

License with Epic Pharma LLC

November 21, 2020 we entered into a license, manufacturing and supply agreement with Epic Pharma LLC (“

Epic ”) to market

the two Elite generic products described below in the United States (the “

Epic Pharma License ”).

on May 23, 2021 and continuing until the agreement terminates, Epic has exclusive marketing rights to Trimipramine Capsules and Isradipine

The products are manufactured by Elite for Epic on a cost plus basis.

In addition to the purchase prices for the products,

Elite also receives license fees of 50% of gross profits or greater, with such being defined as net sales less the price paid to Elite

for the products, distribution fees of less than 10% and shipping costs.

The initial term of the agreement is three (3) years from the

execution of the agreement.

Epic has the option to extend the agreement for an additional two (2) years if certain license fee targets

License with Prasco, LLC and Burel Pharmaceuticals, Inc.

February 14, 2020, and as amended on July 30, 2020, the Company entered into a license, manufacturing and supply agreement with Prasco,

LLC and its affiliate Burel Pharmaceuticals, Inc.

Burel ”) to market generic Loxapine Succinate capsules in the United

States (the “

Burel License ”).

Burel sales for the product began May 2021.

the agreement, Burel has exclusive marketing rights to Loxapine.

The product is manufactured by Elite, and the Company receives manufacturing

fees and license fees of 50% of gross profits or greater, with such being defined as net sales less the price paid to Elite for the products,

distribution fees of less than 10% and shipping costs.

The term of the agreement is three (3) years from the execution date of the agreement

and will automatically renew for one (1) year periods unless one of the parties gives prior written notice.

Marketing Alliances with Lannett Company Inc

Company has entered into two separate license, supply and distribution agreements with Lannett Company Inc.

(“Lannett”).

The first agreement,

dated March 6, 2019, relates to products that were co-developed with SunGen (the “Lannett-SunGen Product Alliance”).

The first agreement, dated March 6, 2019, relates to products that were co-developed with SunGen (the “Lannett-SunGen Product Alliance”).

The second agreement, dated April 9, 2019, relates to products that were solely developed by Elite (the “Lannett-Elite Product

1 unchanged sentence

Both agreements are collectively and individually referred to as the “Lannett Alliance”).

Pursuant to Lannett-SunGen

Product Alliance with Lannett, Lannett will be the exclusive U.S.

Lannett-SunGen Product Alliance, Lannett will be the exclusive U.S.

distributor for Amphetamine IR Tablets and Amphetamine ER Capsules.

Elite manufactures these products, which are purchased, marketed and distributed by Lannett under the Lannett label.

to the purchase prices for the products, Elite will receive license fees well in excess of 50% of net profits, which will be shared

equally with SunGen, pursuant to the SunGen Agreement.

Net profits are defined as net sales less the price paid to Elite for the

products, distribution fees (less than 10%) and shipping costs.

The Lannett-SunGen Product Alliance has an initial term

of three years and automatically renews for one year periods absent prior written notice of non-renewal.

In addition to customary

termination provisions, the Agreement permits Lannett to terminate with regard to a product on at least three months’

written notice if it determines to stop marketing and selling such product, and it permits Elite to terminate with regard to a

product if at any time after the first twelve months from the first commercial sale, the average license fee paid by Lannett for

such product is less than $100,000 for a six month sales period.

In addition to manufacturing fees and license fees, Lannett also

paid a $750,000 milestone, upon the March 2020 commercial launch of Amphetamine ER Capsules.

This milestone payment was earned

during March 2020 and was shared equally by Elite and SunGen, pursuant to the SunGen Agreement.

The first commercial

shipment of Amphetamine IR Tablets, a generic version of Adderall ®

, with strengths of 5mg, 7.5mg, 10mg, 12.5mg,

15mg, 20mg and 30mg, pursuant to the Lannett-SunGen Product Alliance occurred in April 2019.

The first commercial

shipment of Amphetamine ER Capsules, a generic version of Adderall XR ®

, with strengths of 5mg, 10mg, 15mg, 20mg,

25mg and 30mg, pursuant to the Lannett-SunGen Product Alliance occurred in March 2020.

Pursuant to the Lannett-Elite

Product Alliance, Lannett will be the exclusive U.S.

In addition to the

purchase prices for the products, Elite will receive license fees well in excess of 50% of net profits, which will be shared equally

with SunGen, pursuant to the SunGen Agreement.

Net profits are defined as net sales less the price paid to Elite for the products, distribution

fees (less than 10%) and shipping costs.

The Lannett-SunGen Product Alliance has an initial term of three years and automatically renews

for one year periods absent prior written notice of non-renewal.

In addition to customary termination provisions, the Agreement permits

Lannett to terminate with regard to a product on at least three months’

prior written notice if it determines to stop marketing

and selling such product, and it permits Elite to terminate with regard to a product if at any time after the first twelve months from

the first commercial sale, the average license fee paid by Lannett for such product is less than $100,000 for a six month sales period.

In addition to manufacturing fees and license fees, Lannett also paid a $750,000 milestone, upon the March 2020 commercial launch of

Amphetamine ER Capsules.

This milestone payment was earned during March 2020 and was shared equally by Elite and SunGen, pursuant to

the SunGen Agreement.

first commercial shipment of Amphetamine IR Tablets, a generic version of Adderall ®

, with strengths of 5mg, 7.5mg, 10mg,

12.5mg, 15mg, 20mg and 30mg, pursuant to the Lannett-SunGen Product Alliance occurred in April 2019.

first commercial shipment of Amphetamine ER Capsules, a generic version of Adderall XR ®

, with strengths of 5mg, 10mg,

15mg, 20mg, 25mg and 30mg, pursuant to the Lannett-SunGen Product Alliance occurred in March 2020.

to the Lannett-Elite Product Alliance, Lannett will be the exclusive U.S.

distributor for Dantrolene Capsules.

The first commercial shipment of Dantrolene

Capsules, with strengths of 25mg, 50mg and 100mg occurred in June 2019.

Pursuant to the Lannett-Elite

Product Alliance, Elite manufactures for Lannett’s purchase, marketing, and distribution of Dantrolene Capsules under the

Lannett label.

In addition to the purchase prices for the products, Elite will receive license fees well in excess of 50% of gross

The first commercial shipment

of Dantrolene Capsules, with strengths of 25mg, 50mg and 100mg occurred in June 2019.

to the Lannett-Elite Product Alliance, Elite manufactures for Lannett’s purchase, marketing, and distribution of Dantrolene Capsules

under the Lannett label.

In addition to the purchase prices for the products, Elite will receive license fees well in excess of 50% of

gross profits.

Gross profits are defined as net sales less the price paid to Elite for the products, distribution fees (less than 10%)

1 unchanged sentence

Lannett will have exclusive marketing rights to Dantrolene Capsules.

The Lannett-Elite Product Alliance

has an initial term of three years and automatically renews for one year periods absent prior written notice of non-renewal.

addition to customary termination provisions, the Agreement permits Lannett to terminate with regard to a product on at least

three months’

prior written notice if it determines to stop marketing and selling such product, and it permits Elite to

terminate with regard to a product if at any time after the first twelve months from the first commercial sale, the average license

fee paid by Lannett for such product is less than $100,000 for a six month sales period.

In addition to manufacturing fees and

license fees.

Products Under Development

Elite’s research

and development activities include developing its proprietary abuse deterrent technology and the development of a range of abuse

The Lannett-Elite Product Alliance has an initial

term of three years and automatically renews for one year periods absent prior written notice of non-renewal.

In addition to customary

termination provisions, the Agreement permits Lannett to terminate with regard to a product on at least three months’

prior written

notice if it determines to stop marketing and selling such product, and it permits Elite to terminate with regard to a product if at

any time after the first twelve months from the first commercial sale, the average license fee paid by Lannett for such product is less

than $100,000 for a six month sales period.

In addition to manufacturing fees and license fees.

also note that in May 2020, SunGen, under an asset purchase agreement, assigned its rights and obligations under the SunGen Agreement

for Amphetamine IR and Amphetamine ER to Mikah Pharmaceuticals.

The ANDAs for Amphetamine IR and Amphetamine ER are now registered under

Elite’s name.

Mikah will now be Elite’s partner with respect to Amphetamine IR and ER and will assume all the rights and

obligations for these products from SunGen.

Under Development

Elite’s

research and development activities include developing its proprietary abuse deterrent technology and the development of a range of abuse

deterrent opioid products that utilize this technology or other approaches to abuse deterrence.

Elite’s proprietary

abuse-deterrent technology utilizes the pharmacological approach to abuse deterrence and consists of a multi-particulate capsule

which contains an opioid agonist in addition to naltrexone, an opioid antagonist used primarily in the management of alcohol dependence

and opioid dependence.

Elite’s

proprietary abuse-deterrent technology utilizes the pharmacological approach to abuse deterrence and consists of a multi-particulate

capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist used primarily in the management of alcohol

dependence and opioid dependence.

When this product is taken as intended, the naltrexone is designed to pass through the body unreleased

while the opioid agonist releases over time providing therapeutic pain relief for which it is prescribed.

If the multi-particulate

beads are crushed or dissolved, the opioid antagonist, naltrexone, is designed to release.

The absorption of the naltrexone is

intended to block the euphoria by preferentially binding to same receptors in the brain as the opioid agonist and thereby reducing

the incentive for abuse or misuse by recreational drug abusers.

We filed an NDA for

the first product to utilize our abuse deterrent technology, Immediate Release Oxycodone 5mg, 10mg, 15mg, 20mg and 30mg with sequestered

Naltrexone (collectively and individually referred to as “

If the multi-particulate beads

are crushed or dissolved, the opioid antagonist, naltrexone, is designed to release.

The absorption of the naltrexone is intended to

block the euphoria by preferentially binding to same receptors in the brain as the opioid agonist and thereby reducing the incentive

for abuse or misuse by recreational drug abusers.

filed an NDA for the first product to utilize our abuse deterrent technology, Immediate Release Oxycodone 5mg, 10mg, 15mg, 20mg and 30mg

with sequestered Naltrexone (collectively and individually referred to as “

SequestOx™

”), on January 14, 2016.

Please see “

Filed products under FDA review;

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above and please note that continued development of this product is currently paused.

On September 20, 2017,

the Company filed an ANDA with the FDA for generic version of OxyContin®

(extended release Oxycodone Hydrochloride).

Filed products under FDA review;

Oxycodone Hydrochloride extended release (generic version of OxyContin ®”

Please note that there can be no assurances of this product receiving marketing authorization or achieving commercialization.

In addition, even if marketing authorization is received and the product is commercialized, there can be no assurances of future

revenues or profits in such amounts that would provide adequate return on the significant investments made to secure marketing

authorization for this product.

The Company is currently

not selling opioids nor are we pursuing licensing deals for opioids until the market conditions improve.

Further, we have divested

some opioid products.

Company is currently not selling opioids nor are we pursuing licensing deals for opioids until the market conditions improve.

we have divested some opioid products.

The Company will wait for the market to stabilize before pursuing these opportunities.

On January 3, 2019,

the Company filed an Abbreviated New Drug Application with the US Food and Drug Administration for a generic version of an antibiotic

January 3, 2019, the Company filed an Abbreviated New Drug Application with the US Food and Drug Administration for a generic version

of an antibiotic product.

Please see “

Filed products under FDA review ”

Please note that there can be no assurances

of this product receiving marketing authorization or achieving commercialization.

Please note that there can

be no assurances of this product receiving marketing authorization or achieving commercialization.

In addition, even if marketing authorization

is received and the product is commercialized, there can be no assurances of future revenues or profits in such amounts that would

provide adequate return on the significant investments made to secure marketing authorization for this product.

Please also see

the section below titled “

is received and the product is commercialized, there can be no assurances of future revenues or profits in such amounts that would provide

adequate return on the significant investments made to secure marketing authorization for this product.

Please also see the section below

titled “

Master Development and License Agreement with SunGen Pharma LLC ”.

Please note that,

while the FDA is required to review applications within certain timeframes, during the review process, the FDA frequently requests

that additional information be submitted.

The effect of such request and subsequent submission can significantly extend the time

for the NDA review process.

note that, while the FDA is required to review applications within certain timeframes, during the review process, the FDA frequently

requests that additional information be submitted.

The effect of such request and subsequent submission can significantly extend the

time for the NDA review process.

Until an NDA is actually approved, there can be no assurances that the information requested and submitted

will be considered adequate by the FDA to justify approval.

The packaging and labeling of our developed products are also subject

to FDA regulation.

Based on the foregoing, it is impossible to anticipate the amount of time that will be needed to obtain FDA

approval to market any product.

In addition, there can be no assurances of the Company filing the required application(s) with

the FDA or of the FDA approving such application(s) if filed, and the Company’s ability to successfully develop and commercialize

products incorporating its abuse deterrent technology is subject to a high level of risk as detailed in “

Factors-Risks Related to our Business ”

The packaging and labeling of our developed products are also subject to

FDA regulation.

Based on the foregoing, it is impossible to anticipate the amount of time that will be needed to obtain FDA approval

to market any product.

In addition, there can be no assurances of the Company filing the required application(s) with the FDA or of the

FDA approving such application(s) if filed, and the Company’s ability to successfully develop and commercialize products incorporating

its abuse deterrent technology is subject to a high level of risk as detailed in “

Item 1A-Risk Factors-Risks Related to our

Business ”

of this Annual Report on Form 10-K.

Abuse-Deterrent and Sustained Release

The abuse-deterrent

opioid products utilize our patented abuse-deterrent technology that is based on a pharmacological approach.

These products are

combinations of a narcotic agonist formulation intended for use in patients with pain, and an antagonist, formulated to deter

abuse of the drug.

Both, agonist, and antagonist, have been on the market for a number of years and sold separately in various

dose strengths.

We have filed INDs for two abuse resistant products under development and have tested products in various pharmacokinetic

and efficacy studies.

The Company is currently

not selling opioids nor are we pursuing licensing deals for opioids until the market conditions improve.

Further, we have divested

some opioid products.

Abuse-Deterrent

and Sustained Release Opioids

abuse-deterrent opioid products utilize our patented abuse-deterrent technology that is based on a pharmacological approach.

These products

are combinations of a narcotic agonist formulation intended for use in patients with pain, and an antagonist, formulated to deter abuse

Both, agonist, and antagonist, have been on the market for a number of years and sold separately in various dose strengths.

Company is currently not selling opioids nor are we pursuing licensing deals for opioids until the market conditions improve.

we have divested some opioid products.

The Company will wait for the market to stabilize before pursuing these opportunities.

Since our incorporation,

we have secured the following patents, of which two have been assigned for a fee to another pharmaceutical company.

EXPIRATION DATE

patent 6,620,439

our incorporation, we have secured the following patents, of which two have been assigned for a fee to another pharmaceutical company.

Our patents are:

patent 8,182,836

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patent 2,521,655

Canadian patent 2,521,655

Canadian patent 2,541,371

patent 2,541,371

1 unchanged sentence

patent 10213388

We intend to apply

for patents for other products in the future;

however, there can be no assurance that any of the pending applications or other

applications which we may file will be granted.

intend to apply for patents for other products in the future;

however, there can be no assurance that any of the pending applications

or other applications which we may file will be granted.

We have also filed corresponding foreign applications for key patents.

Prior to the enactment

in the United States of new laws adopting certain changes mandated by the General Agreement on Tariffs and Trade (“

to the enactment in the United States of new laws adopting certain changes mandated by the General Agreement on Tariffs and Trade (“

GATT ”),

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Patent were for a period of 17 years measured from the date of grant.

Under GATT, the

term of any U.S.

Patent granted on an application filed subsequent to June 8, 1995 terminates 20 years from the date on which

the patent application was filed in the United States or the first priority date, whichever occurs first.

Future patents granted

on an application filed before June 8, 1995, will have a term that terminates 20 years from such date, or 17 years from the date

of grant, whichever date is later.

Under the Drug Price

Competition Act, a U.S.

product patent or use patent may be extended for up to five years under certain circumstances to compensate

the patent holder for the time required for FDA regulatory review of the product.

Under GATT, the term of

Patent granted on an application filed subsequent to June 8, 1995 terminates 20 years from the date on which the patent application

was filed in the United States or the first priority date, whichever occurs first.

Future patents granted on an application filed before

June 8, 1995, will have a term that terminates 20 years from such date, or 17 years from the date of grant, whichever date is later.

the Drug Price Competition Act, a U.S.

product patent or use patent may be extended for up to five years under certain circumstances

to compensate the patent holder for the time required for FDA regulatory review of the product.

Such benefits under the Drug Price Competition

Act are available only to the first approved use of the active ingredient in the drug product and may be applied only to one patent

per drug product.

Act are available only to the first approved use of the active ingredient in the drug product and may be applied only to one patent per

drug product.

There can be no assurance that we will be able to take advantage of this law.

Also, different countries

have different procedures for obtaining patents, and patents issued by different countries provide different degrees of protection

against the use of a patented invention by others.

There can be no assurance, therefore, that the issuance to us in one country

of a patent covering an invention will be followed by the issuance in other countries of patents covering the same invention,

or that any judicial interpretation of the validity, enforceability, or scope of the claims in a patent issued in one country

will be similar to the judicial interpretation given to a corresponding patent issued in another country.

Furthermore, even if

our patents are determined to be valid, enforceable, and broad in scope, there can be no assurance that competitors will not be

able to design around such patents and compete with us using the resulting alternative technology.

SequestOx™

a trademark owned by Elite, for which United States trademark registration is being sought.

We currently plan

to license at least some of our products to other entities in the marketing of pharmaceuticals but may also sell products under

our own brand name in which case we may register trademarks for those products.

Terminated Agreements

Terminated Agreement

2015 SequestOx™

License Agreement

On June 4, 2020, the

different countries have different procedures for obtaining patents, and patents issued by different countries provide different degrees

of protection against the use of a patented invention by others.

There can be no assurance, therefore, that the issuance to us in one

country of a patent covering an invention will be followed by the issuance in other countries of patents covering the same invention,

or that any judicial interpretation of the validity, enforceability, or scope of the claims in a patent issued in one country will be

similar to the judicial interpretation given to a corresponding patent issued in another country.

Furthermore, even if our patents are

determined to be valid, enforceable, and broad in scope, there can be no assurance that competitors will not be able to design around

such patents and compete with us using the resulting alternative technology.

SequestOx™

License Agreement terminated in accordance with the terms of the agreement.

Other Business Factors and Details

Please see the risk

factor titled “Widespread health problems, including the recent global COVID-19 pandemic, natural disasters or other unexpected

events could materially and adversely affect our business.”

Government Regulation

The design, development,

and marketing of pharmaceutical compounds, on which our success depends, are intensely regulated by governmental regulatory agencies,

in particular the FDA.

Non-compliance with applicable requirements can result in fines and other judicially imposed sanctions,

including product seizures, injunction actions and criminal prosecution based on products or manufacturing practices that violate

statutory requirements.

is a trademark owned by Elite.

currently plan to license at least some of our products to other entities in the marketing of pharmaceuticals but may also sell products

under our own brand name in which case we may register trademarks for those products.

Business Factors and Details

Regulation and Approval

design, development, and marketing of pharmaceutical compounds, on which our success depends, are intensely regulated by governmental

regulatory agencies, in particular the FDA.

Non-compliance with applicable requirements can result in fines and other judicially imposed

sanctions, including product seizures, injunction actions and criminal prosecution based on products or manufacturing practices that

violate statutory requirements.

In addition, administrative remedies can involve voluntary withdrawal of products, as well as the refusal

of the FDA to approve ANDAs and NDAs.

The FDA also has the authority to withdraw approval of drugs in accordance with statutory

due process procedures.

Before a drug may

be marketed, it must be approved by the FDA either by an NDA or an ANDA, each of which is discussed below.

NDAs and NDAs

under Section 505(b) of the Drug Price Competition Act

The FDA approval procedure

for an NDA is generally a two-step process.

During the Initial Product Development stage, an investigational new drug application

The FDA also has the authority to withdraw approval of drugs in accordance with statutory due process

a drug may be marketed, it must be approved by the FDA either by an NDA or an ANDA, each of which is discussed below.

and NDAs under Section 505(b) of the Drug Price Competition Act

FDA approval procedure for an NDA is generally a two-step process.

During the Initial Product Development stage, an investigational new

drug application (“

IND ”) for each product is filed with the FDA.

A 30-day waiting period after the filing of each IND is required

by the FDA prior to the commencement of initial clinical testing.

If the FDA does not comment on or question the IND within such

30-day period, initial clinical studies may begin.

If, however, the FDA has comments or questions, they must be answered to the

satisfaction of the FDA before initial clinical testing may begin.

A 30-day waiting period after the filing of each

IND is required by the FDA prior to the commencement of initial clinical testing.

If the FDA does not comment on or question the IND

within such 30-day period, initial clinical studies may begin.

If, however, the FDA has comments or questions, they must be answered

to the satisfaction of the FDA before initial clinical testing may begin.

In some instances, this process could result in substantial

delay and expense.

Initial clinical studies generally constitute Phase I of the NDA process and are conducted to demonstrate the

product tolerance/safety and pharmacokinetic in healthy subjects.

After Phase I testing,

extensive efficacy and safety studies in patients must be conducted.

After completion of the required clinical testing, an NDA

is filed, and its approval, which is required for marketing in the United States, involves an extensive review process by the FDA.

The NDA itself is a complicated and detailed application and must include the results of extensive clinical and other testing,

the cost of which is substantial.

However, the NDA filings contemplated by us, which are already marketed drugs, would be made

under Sections 505 (b)(1) or 505 (b)(2) of the Drug Price Competition Act, which do not require certain studies that would otherwise

be necessary;

accordingly, the development timetable should be shorter.

While the FDA is required to review applications within

a certain timeframe, during the review process, the FDA frequently requests that additional information be submitted.

of such request and subsequent submission can significantly extend the time for the NDA review process.

Until an NDA is approved,

there can be no assurance that the information requested and submitted will be considered adequate by the FDA to justify approval.

The packaging and labelling of our developed products are also subject to FDA regulation.

It is impossible to anticipate the amount

of time that will be needed to obtain FDA approval to market any product.

Whether or not FDA

approval has been obtained, approval of the product by comparable regulatory authorities in any foreign country must be obtained

Initial clinical studies generally constitute Phase I of the NDA process and are conducted to demonstrate the product

tolerance/safety and pharmacokinetic in healthy subjects.

Phase I testing, extensive efficacy and safety studies in patients must be conducted.

After completion of the required clinical testing,

an NDA is filed, and its approval, which is required for marketing in the United States, involves an extensive review process by the

The NDA itself is a complicated and detailed application and must include the results of extensive clinical and other testing, the

cost of which is substantial.

However, the NDA filings contemplated by us, which are already marketed drugs, would be made under Sections

505 (b)(1) or 505 (b)(2) of the Drug Price Competition Act, which do not require certain studies that would otherwise be necessary;

the development timetable should be shorter.

While the FDA is required to review applications within a certain timeframe, during the

review process, the FDA frequently requests that additional information be submitted.

The effect of such request and subsequent submission

can significantly extend the time for the NDA review process.

Until an NDA is approved, there can be no assurance that the information

requested and submitted will be considered adequate by the FDA to justify approval.

The packaging and labelling of our developed products

are also subject to FDA regulation.

It is impossible to anticipate the amount of time that will be needed to obtain FDA approval to market

or not FDA approval has been obtained, approval of the product by comparable regulatory authorities in any foreign country must be obtained

prior to the commencement of marketing of the product in that country.

We intend to conduct all marketing in territories other

than the United States through other pharmaceutical companies based in those countries.

The approval procedure varies from country

to country, can involve additional testing, and the time required may differ from that required for FDA approval.

Although there

are some procedures for unified filings for certain European countries, in general each country has its own procedures and requirements,

many of which are time consuming and expensive.

Thus, there can be substantial delays in obtaining required approvals from both

the FDA and foreign regulatory authorities after the relevant applications are filed.

After such approvals are obtained, further

delays may be encountered before the products become commercially available.

The FDA approval procedure

for an ANDA differs from the procedure for an NDA in that the FDA waives the requirement of conducting complete clinical studies,

although it normally requires bioavailability and/or bioequivalence studies.

We intend to conduct all marketing in territories other than the

United States through other pharmaceutical companies based in those countries.

The approval procedure varies from country to country,

can involve additional testing, and the time required may differ from that required for FDA approval.

Although there are some procedures

for unified filings for certain European countries, in general each country has its own procedures and requirements, many of which are

time consuming and expensive.

Thus, there can be substantial delays in obtaining required approvals from both the FDA and foreign regulatory

authorities after the relevant applications are filed.

After such approvals are obtained, further delays may be encountered before the

products become commercially available.

FDA approval procedure for an ANDA differs from the procedure for an NDA in that the FDA waives the requirement of conducting complete

clinical studies, although it normally requires bioavailability and/or bioequivalence studies.

Bioavailability ”

indicates the

rate and extent of absorption and levels of concentration of a drug product in the blood stream needed to produce a therapeutic

the rate and extent of absorption and levels of concentration of a drug product in the blood stream needed to produce a therapeutic effect.

Bioequivalence ”

compares the bioavailability of one drug product with another, and when established,

indicates that the rate of absorption and levels of concentration of the active drug substance in the body are equivalent for

the generic drug and the previously approved drug.

An ANDA may be submitted for a drug on the basis that it is the equivalent

of a previously approved drug or, in the case of a new dosage form, is suitable for use for the indications specified.

The timing of final

FDA approval of an ANDA depends on a variety of factors, including whether the applicant challenges any listed patents for the

drug and whether the brand-name manufacturer is entitled to one or more statutory exclusivity periods, during which the FDA may

compares the bioavailability of one drug product with another, and when established, indicates that

the rate of absorption and levels of concentration of the active drug substance in the body are equivalent for the generic drug and the

previously approved drug.

An ANDA may be submitted for a drug on the basis that it is the equivalent of a previously approved drug or,

in the case of a new dosage form, is suitable for use for the indications specified.

timing of final FDA approval of an ANDA depends on a variety of factors, including whether the applicant challenges any listed patents

for the drug and whether the brand-name manufacturer is entitled to one or more statutory exclusivity periods, during which the FDA may

be prohibited from accepting applications for, or approving, generic products.

In certain circumstances, a regulatory exclusivity

period can extend beyond the life of a patent, and thus block ANDAs from being approved on the patent expiration date.

In May 1992, Congress

enacted the Generic Drug Enforcement Act of 1992, which allows the FDA to impose debarment and other penalties on individuals

and companies that commit certain illegal acts relating to the generic drug approval process.

In certain circumstances, a regulatory exclusivity period

can extend beyond the life of a patent, and thus block ANDAs from being approved on the patent expiration date.

May 1992, Congress enacted the Generic Drug Enforcement Act of 1992, which allows the FDA to impose debarment and other penalties on

individuals and companies that commit certain illegal acts relating to the generic drug approval process.

In some situations, the Generic

Drug Enforcement Act requires the FDA to not accept or review ANDAs for a period of time from a company or an individual that

has committed certain violations.

It also provides for temporary denial of approval of applications during the investigation of

certain violations that could lead to debarment and also, in more limited circumstances, provides for the suspension of the marketing

of approved drugs by the affected company.

Lastly, the Generic Drug Enforcement Act allows for civil penalties and withdrawal

of previously approved applications.

Drug Enforcement Act requires the FDA to not accept or review ANDAs for a period of time from a company or an individual that has committed

certain violations.

It also provides for temporary denial of approval of applications during the investigation of certain violations

that could lead to debarment and also, in more limited circumstances, provides for the suspension of the marketing of approved drugs

by the affected company.

Lastly, the Generic Drug Enforcement Act allows for civil penalties and withdrawal of previously approved applications.

Neither we nor any of our employees have ever been subject to debarment.

We do not believe

that we receive any services from any debarred person.

Controlled Substances

We are also subject

to federal, state, and local laws of general applicability, such as laws relating to working conditions.

We are also licensed

by, registered with, and subject to periodic inspection and regulation by the Drug Enforcement Agency (“

We do not believe that we receive any services from any debarred

are also subject to federal, state, and local laws of general applicability, such as laws relating to working conditions.

licensed by, registered with, and subject to periodic inspection and regulation by the Drug Enforcement Agency (“

and New Jersey state agencies, pursuant to federal and state legislation relating to drugs and narcotics.

Certain drugs that we

currently develop or may develop in the future may be subject to regulations under the Controlled Substances Act and related statutes.

As we manufacture such products, we may become subject to the Prescription Drug Marketing Act, which regulates wholesale distributors

of prescription drugs.

All facilities and

manufacturing techniques used for the manufacture of products for clinical use or for sale must be operated in conformity with

cGMP regulations issued by the FDA.

We engage in manufacturing on a commercial basis for distribution of products and operate

our facilities in accordance with cGMP regulations.

If we hire another company to perform contract manufacturing for us, we must

ensure that our contractor’s facilities conform to cGMP regulations.

Compliance with

Environmental Laws

We are subject to

comprehensive federal, state and local environmental laws and regulations that govern, among other things, air polluting emissions,

waste water discharges, solid and hazardous waste disposal, and the remediation of contamination associated with current or past

generation handling and disposal activities, including the past practices of corporations as to which we are the legal successor

Certain drugs that we currently

develop or may develop in the future may be subject to regulations under the Controlled Substances Act and related statutes.

As we manufacture

such products, we may become subject to the Prescription Drug Marketing Act, which regulates wholesale distributors of prescription drugs.

facilities and manufacturing techniques used for the manufacture of products for clinical use or for sale must be operated in conformity

with cGMP regulations issued by the FDA.

We engage in manufacturing on a commercial basis for distribution of products and operate our

facilities in accordance with cGMP regulations.

If we hire another company to perform contract manufacturing for us, we must ensure that

our contractor’s facilities conform to cGMP regulations.

with Environmental Laws

are subject to comprehensive federal, state and local environmental laws and regulations that govern, among other things, air polluting

emissions, wastewater discharges, solid and hazardous waste disposal, and the remediation of contamination associated with current or

past generation handling and disposal activities, including the past practices of corporations as to which we are the legal successor

or in possession.

2 unchanged sentences

There can be no assurance, however, that future changes in environmental

laws or regulations, administrative actions or enforcement actions, or remediation obligations arising under environmental laws

will not have a material adverse effect on our capital expenditures, earnings, or competitive position.

We have competition

with respect to our principal areas of operation.

laws or regulations, administrative actions or enforcement actions, or remediation obligations arising under environmental laws will

not have a material adverse effect on our capital expenditures, earnings, or competitive position.

have competition with respect to our principal areas of operation.

We develop and manufacture generic products, products using controlled-release

drug technology, products utilizing abuse deterrent technologies, and we develop and market (either on our own or by license to

other companies) generic and proprietary controlled-release and abuse deterrent pharmaceutical products.

In both areas, our competition

consists of those companies which develop controlled release, abuse deterrent drugs and alternative drug delivery systems.

not represent a significant presence in the pharmaceutical industry.

An increasing number

of pharmaceutical companies have become interested in the development and commercialization of products incorporating advanced

or novel drug delivery systems.

drug technology, products utilizing abuse deterrent technologies, and we develop and market (either on our own or by license to other

companies) generic and proprietary controlled-release and abuse deterrent pharmaceutical products.

In both areas, our competition consists

of those companies which develop controlled release, abuse deterrent drugs and alternative drug delivery systems.

We do not represent

a significant presence in the pharmaceutical industry.

increasing number of pharmaceutical companies have become interested in the development and commercialization of products incorporating

advanced or novel drug delivery systems.

Some of the major pharmaceutical companies have invested and are continuing to invest significant

resources in the development of their own drug delivery systems and technologies and some have invested funds in such specialized

drug delivery companies.

Many of these companies have greater financial and other resources as well as more experience than we

do in commercializing pharmaceutical products.

Certain companies have a track record of success in developing controlled-release

Significant among these are, without limitation, Pfizer, Sandoz (a Novartis company), Mylan Laboratories, Inc., Endo Pharmaceuticals,

Inc., Teva Pharmaceuticals Industries Ltd., Amneal Laboratories, Inc., Mallinckrodt, and Aurobindo.

Each of these companies has

developed expertise in certain types of drug delivery systems, although such expertise does not carry over to developing a controlled-release

version of all drugs.

Such companies may develop new drug formulations and products or may improve existing drug formulations

and products more efficiently than we can.

In addition, almost all of our competitors have vastly greater resources than we do.

While our product development capabilities and, if obtained, patent protection may help us to maintain our market position in

the field of advanced drug delivery, there can be no assurance that others will not be able to develop such capabilities or alternative

technologies outside the scope of our patents, if any, or that even if patent protection is obtained, such patents will not be

successfully challenged in the future.

In addition to competitors

that are developing products based on drug delivery technologies, there are also companies that have announced that they are developing

opioid abuse-deterrent products that might compete directly or indirectly with Elite’s products.

These include, but are not

limited to Pfizer Inc., Collegium Pharmaceuticals, Inc., and Purdue Pharma LP.

We also face competition

in the generic pharmaceutical market.

resources in the development of their own drug delivery systems and technologies and some have invested funds in such specialized drug

delivery companies.

Many of these companies have greater financial and other resources as well as more experience than we do in commercializing

pharmaceutical products.

Certain companies have a track record of success in developing controlled-release drugs.

Significant among these

are, without limitation, Pfizer, Sandoz (a Novartis company), Mylan Laboratories, Inc., Endo Pharmaceuticals, Inc., Teva Pharmaceuticals

Industries Ltd., Amneal Laboratories, Inc., Mallinckrodt, and Aurobindo.

Each of these companies has developed expertise in certain types

of drug delivery systems, although such expertise does not carry over to developing a controlled-release version of all drugs.

Such companies

may develop new drug formulations and products or may improve existing drug formulations and products more efficiently than we can.

addition, almost all of our competitors have vastly greater resources than we do.

While our product development capabilities and, if

obtained, patent protection may help us to maintain our market position in the field of advanced drug delivery, there can be no assurance

that others will not be able to develop such capabilities or alternative technologies outside the scope of our patents, if any, or that

even if patent protection is obtained, such patents will not be successfully challenged in the future.

addition to competitors that are developing products based on drug delivery technologies, there are also companies that have announced

that they are developing opioid abuse-deterrent products that might compete directly or indirectly with Elite’s products.

include, but are not limited to Pfizer Inc., Collegium Pharmaceuticals, Inc., and Purdue Pharma LP.

also face competition in the generic pharmaceutical market.

The principal competitive factors in the generic pharmaceutical market include:

(i) introduction

of other generic drug manufacturers’

products in direct competition with our products under development, (ii) introduction

of authorized generic products in direct competition with any of our products under development, particularly if such products

are approved and sold during exclusivity periods, (iii) consolidation among distribution outlets through mergers and acquisitions

and the formation of buying groups, (iv) ability of generic competitors to quickly enter the market after the expiration of patents

or exclusivity periods, diminishing the amount and duration of significant profits, (v) the willingness of generic drug customers,

including wholesale and retail customers, to switch among pharmaceutical manufacturers, (vi) pricing pressures and product deletions

by competitors, (vii) a company’s reputation as a manufacturer and distributor of quality products, (viii) a company’s

level of service (including maintaining sufficient inventory levels for timely deliveries), (ix) product appearance and labelling

and (x) a company’s breadth of product offerings.

Sources and Availability of Raw Materials;

(i) introduction of other generic drug manufacturers’

products in direct competition with our products under development, (ii)

introduction of authorized generic products in direct competition with any of our products under development, particularly if such products

are approved and sold during exclusivity periods, (iii) consolidation among distribution outlets through mergers and acquisitions and

the formation of buying groups, (iv) ability of generic competitors to quickly enter the market after the expiration of patents or exclusivity

periods, diminishing the amount and duration of significant profits, (v) the willingness of generic drug customers, including wholesale

and retail customers, to switch among pharmaceutical manufacturers, (vi) pricing pressures and product deletions by competitors, (vii)

a company’s reputation as a manufacturer and distributor of quality products, (viii) a company’s level of service (including

maintaining sufficient inventory levels for timely deliveries), (ix) product appearance and labelling and (x) a company’s breadth

of product offerings.

and Availability of Raw Materials;

Manufacturing

A significant portion

of our raw materials may be available only from foreign sources.

Foreign sources can be subject to the special risks of doing

business abroad, including:

greater possibility for disruption due to transportation or

communication problems;

the relative instability of some foreign governments and economies;

interim price volatility based on labor unrest, materials or

equipment shortages, export duties, restrictions on the transfer of funds, or fluctuations in currency exchange rates;

uncertainty regarding recourse to a dependable legal system

for the enforcement of contracts and other rights.

While we currently

obtain the raw materials that we need from over 20 suppliers, some materials used in our products are currently available from

only one supplier or a limited number of suppliers.

The FDA requires identification of raw material suppliers in applications

for approval of drug products.

If raw materials were unavailable from a specified supplier, FDA approval of a new supplier could

delay the manufacture of the drug involved.

We have acquired pharmaceutical manufacturing

equipment for manufacturing our products.

We have registered our facilities with the FDA and the DEA.

Please see the Risk

Factor in Part I, Item 1A entitled “

We are dependent on a small number of suppliers for our raw materials and any delay

or unavailability of raw materials can materially adversely affect our ability to produce products ”.

Dependence on One or a Few Major Customers

Each year we have had

one or a few customers that have accounted for a large percentage of our limited revenues, therefore the termination or restructuring

of a contract with a customer may result in the loss of material amount or substantially all of our revenues.

We are constantly

working to develop new relationships with existing or new customers, but despite these efforts we may not, at the time that any

of our current contracts expire, have other contracts in place generating similar or material revenue.

We have agreements with

Lannett, Glenmark and Precision Dose for the licensing, sales and distribution of products that we manufacture.

We receive revenues

to manufacture these products and also receive a profit split or royalties based on in-market sales of the products.

the Risk Factor in Part I, Item 1A entitled “

We depend on a limited number of customers and any reduction, delay or cancellation

of an order from these customers or the loss of any of these customers could cause our revenue to decline .”

Our Reporting Segments

We currently operate

in two segments, which are products whose marketing approvals were secured via an ANDA and products whose marketing approvals

were secured via an NDA.

ANDA products are referred to as generic pharmaceuticals and NDA products are referred to as branded

pharmaceuticals.

For the years ended March 31, 2020 and 2019 revenue from our ANDA segment were $17.0 million and $6.6 million,

respectively.

For the years ended March 31, 2020 and 2019 revenue from our NDA segment were $1.0 million and $1.0 million, respectively.

Segment information

is consistent with the financial information regularly reviewed by our chief operating decision maker, who we have determined

to be the chief executive office, for the purposes of making decisions about allocating resources and assessing performance of

significant portion of our raw materials may be available only from foreign sources.

Foreign sources can be subject to the special risks

of doing business abroad, including:

possibility for disruption due to transportation or communication problems;

relative instability of some foreign governments and economies;

price volatility based on labor unrest, materials or equipment shortages, export duties, restrictions on the transfer of funds, or

fluctuations in currency exchange rates;

regarding recourse to a dependable legal system for the enforcement of contracts and other rights.

we currently obtain the raw materials that we need from over 20 suppliers, some materials used in our products are currently available

from only one supplier or a limited number of suppliers.

The FDA requires identification of raw material suppliers in applications for

approval of drug products.

If raw materials were unavailable from a specified supplier, FDA approval of a new supplier could delay the

manufacture of the drug involved.

have acquired pharmaceutical manufacturing equipment for manufacturing our products.

We have registered our facilities with the FDA and

see the Risk Factor in Part I, Item 1A entitled “We are dependent on a small number of customers, suppliers and other third parties

for core business aspects”

on One or a Few Major Customers

year we have had one or a few customers that have accounted for a large percentage of our limited revenues, therefore the termination

or restructuring of a contract with a customer may result in the loss of material amount or substantially all of our revenues.

constantly working to develop new relationships with existing or new customers, but despite these efforts we may not, at the time that

any of our current contracts expire, have other contracts in place generating similar or material revenue.

We have agreements with Lannett,

Epic Pharma, Burel Pharmaceuticals and Precision Dose for the licensing, sales and distribution of products that we manufacture.

revenues to manufacture these products and also receive a profit split or royalties based on in-market sales of the products.

see the Risk Factor in Part I, Item 1A entitled We are dependent on a small number of customers, suppliers and other third parties for

core business aspects”

Reporting Segments

We currently operate in two

segments, which are products whose marketing approvals were secured via an ANDA and products whose marketing approvals were secured via

ANDA products are referred to as generic pharmaceuticals and NDA products are referred to as branded pharmaceuticals.

years ended March 31, 2021 and 2020 revenue from our ANDA segment were $25.2 million and $17.0 million, respectively.

For the years ended

March 31, 2020 and 2019 revenue from our NDA segment were $0.2 million and $1.0 million, respectively.

information is consistent with the financial information regularly reviewed by our chief operating decision maker, who we have determined

to be the chief executive office, for the purposes of making decisions about allocating resources and assessing performance of the Company.

There are currently no intersegment revenues.

Asset information by operating segment is not presented below since

the chief operating decision maker does not review this information by segment.

As of June 15, 2020,

we had 43 full time employees.

Asset information by operating segment is not presented below since the chief operating

decision maker does not review this information by segment.

As of June 7, 2021, we had

43 full time employees.

Full-time employees are engaged in operations, administration, research, and development.

our employees is represented by a labor union and we have never experienced a work stoppage.

We believe our relationship with our

employees to be good.

However, our ability to achieve our financial and operational objectives depends in large part upon our continuing

ability to attract, integrate, retain, and motivate highly qualified personnel, and upon the continued service of our senior management

and key personnel.

Available Information

We file our annual

reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K pursuant to Section 13(a) or 15(d) of the

Exchange Act electronically with the Securities and Exchange Commission, or SEC.

The SEC maintains an Internet site that contains

reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC.

address of that site is http://www.sec.gov .

You may obtain a free

copy of our annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K and amendments to those

reports on the day of filing with the SEC on our website at http://www.Elitepharma.com under the Investor Relations tab

for SEC Filings or by contacting the Investor Relations Department by calling (518) 398-6222 or sending an e-mail message to dianne@elitepharma.com .

None of our employees

is represented by a labor union and we have never experienced a work stoppage.

We believe our relationship with our employees to be good.

However, our ability to achieve our financial and operational objectives depends in large part upon our continuing ability to attract,

integrate, retain, and motivate highly qualified personnel, and upon the continued service of our senior management and key personnel.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business