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Item 3. Legal Proceedings

2026-03-30 compared with 2025-03-27 · 83 added, 52 removed, 3 unchanged (98% of the section changed)

Legal proceedings

2020, we received a Paragraph IV certification notice letter (the “IMVEXXY Notice Letter”) regarding an Abbreviated New Drug

Application (“ANDA”) submitted to the FDA by Teva Pharmaceuticals USA, Inc.

The ANDA seeks approval

from the FDA to commercially manufacture, use, or sell a generic version of the 4 mcg and 10 mcg doses of IMVEXXY.

In the IMVEXXY Notice

Letter, Teva alleges that TherapeuticsMD patents listed in the FDA’s Orange Book that claim compositions and methods of IMVEXXY

(the “IMVEXXY Patents”) are invalid, unenforceable, and/or will not be infringed by Teva’s commercial manufacture,

use, or sale of its proposed generic drug product.

The IMVEXXY Patents identified in the IMVEXXY Notice Letter expire in 2032 or 2033.

In April 2020, we filed a complaint for patent infringement against Teva in the United States District Court for the District of New

Jersey arising from Teva’s ANDA filing with the FDA.

We are seeking, among other relief, an order that the effective date of any

FDA approval of Teva’s ANDA would be a date no earlier than the expiration of the IMVEXXY Patents and equitable relief enjoining

Teva from infringing the IMVEXXY Patents.

Teva has filed its answer and counterclaim to the complaint, alleging that the IMVEXXY Patents

are invalid and not infringed.

In July 2021, following a proposal by Teva, the District Court entered an order temporarily staying all

proceedings in the IMVEXXY litigation, which order was filed under seal.

In September 2021, the District Court made available a public

version of the order following the parties’ agreement to a consent motion to redact information Teva contended was confidential.

The order provides that the statutory stay that prevents the FDA from granting final approval of the ANDA for 30 months from the date

of the IMVEXXY Notice Letter will be extended for the number of days that the stay of the IMVEXXY litigation is in place.

2024, the court lifted the stay.

We have incurred and recorded legal costs amounting to $2,334 thousand in prepaid expenses and other

current assets as of December 31, 2024, for the IMVEXXY Paragraph IV legal proceeding since we believe that we will successfully prevail

in this legal proceeding.

Upon the successful conclusion of the legal proceeding, the related capitalized legal costs will be reclassified

to patents, in license rights and other intangible assets, net, in the accompanying consolidated balance sheets, and such costs will

be amortized over the remaining useful life of the patents.

If we are unsuccessful in this legal proceeding, then the related capitalized

legal costs for this legal preceding and any unamortized IMVEXXY patent costs that were previously capitalized will be immediately expensed

in the period in which we become aware of an unsuccessful legal proceeding.

2024, Mayne Pharma received a Paragraph IV certification notice letter (the “Sun Notice Letter”) regarding an ANDA

submitted to the FDA by Sun Pharma Inc.

(“Sun Pharma”).

The ANDA seeks approval from the FDA to commercially

manufacture, use, or sell a generic version of the 4 mcg and 10 mcg doses of IMVEXXY.

In the Sun Notice Letter, Sun Pharma alleges

that the IMVEXXY Patents are invalid, unenforceable, and/or will not be infringed by Sun Pharma’s commercial manufacture, use,

or sale of its proposed generic drug product.

The IMVEXXY Patents identified in the Sun Notice Letter expire in 2032 or 2033.

July 2024, we and Mayne Pharma filed a complaint for patent infringement against Sun Pharma in the United States District Court for

the District of New Jersey arising from Sun Pharma’s ANDA filing with the FDA.

We are seeking, among other relief, an order

that the effective date of any FDA approval of Sun Pharma’s ANDA would be a date no earlier than the expiration of the IMVEXXY

Patents and equitable relief enjoining Sun Pharma from infringing the IMVEXXY Patents.

on December 30, 2022 and per the Mayne License Agreement, Mayne Pharma is responsible for all enforcement of our patents, including the

responsibility for and costs of litigation discussed above with respect to Teva and Sun Pharma.

to time, we are involved in other litigations and proceedings in the ordinary course of business.

We are currently not involved in any

other litigations and proceedings that we believe would have a material effect on our consolidated financial condition, results of operations,

or cash flows.

In February 2020, we received a Paragraph IV certification notice letter

(the “IMVEXXY Notice Letter”) regarding an Abbreviated New Drug Application (“ANDA”) submitted to the FDA by Teva

Pharmaceuticals USA, Inc.

The ANDA seeks approval from the FDA to commercially manufacture, use, or sell a generic

version of the 4 mcg and 10 mcg doses of IMVEXXY.

In the IMVEXXY Notice Letter, Teva alleges that TherapeuticsMD patents listed in the

FDA’s Orange Book that claim compositions and methods of IMVEXXY (the “IMVEXXY Patents”) are invalid, unenforceable,

and/or will not be infringed by Teva’s commercial manufacture, use, or sale of its proposed generic drug product.

The IMVEXXY Patents

identified in the IMVEXXY Notice Letter expire in 2032 or 2033.

In April 2020, we filed a complaint for patent infringement against Teva

in the United States District Court for the District of New Jersey arising from Teva’s ANDA filing with the FDA.

We are seeking,

among other relief, an order that the effective date of any FDA approval of Teva’s ANDA would be a date no earlier than the expiration

of the IMVEXXY Patents and equitable relief enjoining Teva from infringing the IMVEXXY Patents.

Teva has filed its answer and counterclaim

to the complaint, alleging that the IMVEXXY Patents are invalid and not infringed.

In July 2021, following a proposal by Teva, the District

Court entered an order temporarily staying all proceedings in the IMVEXXY litigation, which order was filed under seal.

In September 2021,

the District Court made available a public version of the order following the parties’ agreement to a consent motion to redact information

Teva contended was confidential.

The order provides that the statutory stay that prevents the FDA from granting final approval of the

ANDA for 30 months from the date of the IMVEXXY Notice Letter will be extended for the number of days that the stay of the IMVEXXY litigation

In November 2024, the court lifted the stay.

We have incurred and recorded legal costs amounting to $2,334 thousand in prepaid

expenses and other current assets as of December 31, 2025, for the IMVEXXY Paragraph IV legal proceeding since we believe that we will

successfully prevail in this legal proceeding.

Upon the successful conclusion of the legal proceeding, the related capitalized legal costs

will be reclassified to patents, in license rights and other intangible assets, net, in the accompanying consolidated balance sheets,

and such costs will be amortized over the remaining useful life of the patents.

If we are unsuccessful in this legal proceeding, then

the related capitalized legal costs for this legal proceeding and any unamortized IMVEXXY patent costs that were previously capitalized

will be immediately expensed in the period in which we become aware of an unsuccessful legal proceeding.

In June 2024, Mayne Pharma received the Sun Notice Letter regarding

an ANDA submitted to the FDA by Sun Pharma.

The ANDA seeks approval from the FDA to commercially manufacture, use, or sell a generic version

of the 4 mcg and 10 mcg doses of IMVEXXY.

In the Sun Notice Letter, Sun Pharma alleges that the IMVEXXY Patents are invalid, unenforceable,

and/or will not be infringed by Sun Pharma’s commercial manufacture, use, or sale of its proposed generic drug product.

Patents identified in the Sun Notice Letter expire in 2032 or 2033.

In July 2024, we and Mayne Pharma filed a complaint for patent infringement

against Sun Pharma in the United States District Court for the District of New Jersey arising from Sun Pharma’s ANDA filing with

We are seeking, among other relief, an order that the effective date of any FDA approval of Sun Pharma’s ANDA would be

a date no earlier than the expiration of the IMVEXXY Patents and equitable relief enjoining Sun Pharma from infringing the IMVEXXY Patents.

As of December 31, 2025, the litigation remains ongoing and has progressed to claim construction, which the courts determine the meaning

and scope of the asserted patent claims that will govern subsequent infringement and validity analysis.

Beginning on December 30, 2022 and per the Mayne License Agreement,

Mayne Pharma is responsible for all enforcement of our patents, including the responsibility for and costs of litigation discussed above

with respect to Teva and Sun Pharma.

On April 8, 2025, we filed the Mayne Lawsuit seeking damages for breach

of contract, breach of the implied covenant of good faith and fair dealing, fraudulent inducement, and unjust enrichment related to Mayne

Pharma’s actions in relation to the License Agreement and the Transaction Agreement, primarily relating to the net working capital

allowances and certain actions or inactions by Mayne Pharma relating thereto.

On June 20, 2025, we filed an amended complaint against

Mayne Pharma and on July 22, 2025, Mayne Pharma filed a motion to dismiss the Mayne Lawsuit.

On March 23, 2026, a magistrate judge recommended

that the court grant-in-part and deny-in-part Mayne Pharma’s motion to dismiss.

The magistrate judge recommended granting Mayne’s

motion to dismiss our claims for breach of the covenant of good faith and fair dealing, certain of our breach of contract claims and our

claim for fraudulent inducement, but recommended the court grant us leave to amend the fraudulent inducement claim.

The magistrate judge

recommended denying Mayne’s motion to dismiss our other claims.

The magistrate judge further recommended the court stay the Mayne

Lawsuit while the parties submit the net working capital claims to a dispute resolution process.

The parties have 14 days to object to

these recommendations.

On May 30, 2025, Mayne Pharma filed the Mayne Countersuit seeking damages

for breach of contract and fraudulent inducement related to the Transaction Agreement.

As part of the Mayne Countersuit, Mayne Pharma

also made certain indemnification demands under the Transaction Agreement, which we dispute.

On July 28, 2025, we filed a motion to dismiss

the fraudulent inducement claim in the Mayne Countersuit.

On March 23, 2026, a magistrate judge recommended that the court grant our motion

to dismiss Mayne Pharma’s claim for fraudulent inducement, but recommended the court deny our motion to dismiss Mayne Pharma’s

other claims.

The parties have 14 days to object to this recommendation.

As of December 31, 2025, we believed no additional accrual was

required for such claims, as we could not reasonably estimate a range of loss.

From time to time, we are involved in other litigations and proceedings

in the ordinary course of business.

We are currently not involved in any other litigations and proceedings that we believe would have

a material effect on our consolidated financial condition, results of operations, or cash flows.

Mine safety disclosures

1 unchanged sentence

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 3. Legal Proceedings