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Item 3. Legal Proceedings

2025-03-27 compared with 2024-03-29 · 48 added, 35 removed, 7 unchanged (92% of the section changed)

Legal proceedings

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

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.

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.

The length of the stay of the IMVEXXY litigation is dependent

on further action by Teva.

As of December 31, 2022, for the IMVEXXY Paragraph IV legal proceeding, we had incurred and recorded legal

costs amounting to $2.3 million in prepaid expenses and other current assets 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.

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

1 unchanged sentence

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

As of December 30, 2022, and per the Mayne License Agreement,

Mayne Pharma is responsible for all enforcement of our patents, including this litigation with Teva.

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.

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.

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