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. 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. 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. 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.
Item 4. Mine safety disclosures
Not applicable.
32
PART II