Item 8.01Other Events.
As previously disclosed, in February 2020, TherapeuticsMD, Inc., a Nevada
corporation (the "Company"), received a Paragraph IV certification notice letter
(the "Notice Letter") regarding an Abbreviated New Drug Application ("ANDA")
submitted to the U.S. Food and Drug Administration ("FDA") by Teva
Pharmaceuticals USA, Inc. ("Teva"). The ANDA seeks approval from FDA to
commercially manufacture, use, or sell a generic version of the 4 mcg and 10 mcg
doses of the Company's IMVEXXY (estradiol vaginal inserts) pharmaceutical
product for the treatment of moderate-to-severe dyspareunia (vaginal pain
associated with sexual activity), a symptom of vulvar and vaginal atrophy due to
menopause. In the Notice Letter, Teva alleged that the Company patents listed in
FDA's Orange Book that claim compositions and methods of IMVEXXY, 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 Notice Letter expire in 2032 or 2033.
In April 2020, the Company 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 FDA, 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 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.
On September 2, 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 FDA from granting final
approval of the ANDA for 30 months from the date of the 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.
Forward-Looking Statements
This Current Report on Form 8-K may contain forward-looking statements.
Forward-looking statements may include, but are not limited to, statements
relating to the Company's objectives, plans and strategies as well as
statements, other than historical facts, that address activities, events or
developments that the Company intends, expects, projects, believes or
anticipates will or may occur in the future. These statements are often
characterized by terminology such as "believes," "hopes," "may," "anticipates,"
"should," "intends," "plans," "will," "expects," "estimates," "projects,"
"positioned," "strategy" and similar expressions and are based on assumptions
and assessments made in light of management's experience and perception of
historical trends, current conditions, expected future developments and other
factors believed to be appropriate. Forward-looking statements in this Current
Report on From 8-K are made as of the date of this report, and the Company
undertakes no duty to update or revise any such statements, whether as a result
of new information, future events or otherwise. Forward-looking statements are
not guarantees of future performance and are subject to risks and uncertainties,
many of which are outside of the Company's control. Important factors that could
cause actual results, developments and business decisions to differ materially
from forward-looking statements are described in the sections titled "Risk
Factors" in the Company's filings with the Securities and Exchange Commission,
including its most recent Annual Report on Form 10-K and Quarterly Reports on
Form 10-Q, as well as reports on Form 8-K, and include the effects of the
IMVEXXY Paragraph IV litigation.
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