Item 3. Legal Proceedings
Item
3. 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. (“Teva”). 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. 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, 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.
In June
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. 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 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.
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.
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.
Item
4. Mine safety disclosures
Not applicable.
39
PART
II