TherapeuticsMD Announces Patent Updates for ANNOVERA®
September 09 2020 - 4:05PM
Business Wire
New patents expand U.S. patent protection for
ANNOVERA
TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s
healthcare company, today announced patent updates for ANNOVERA
(segesterone acetate and ethinyl estradiol vaginal system), the
first and only long-lasting, patient-controlled, procedure-free,
reversible prescription contraceptive option for women. On
September 8, 2020, the United States Patent and Trademark Office
(USPTO) issued its second ANNOVERA patent (U.S. Patent No.
10,765,628) that can be listed in the U.S. Food and Drug
Administration’s (FDA) Approved Drug Products with Therapeutic
Equivalence Evaluations (commonly known as the Orange Book). In
addition, based on recent communications from the USPTO, a third
ANNOVERA patent (U.S. Patent No. 10,780,047) is scheduled to be
issued on September 22, 2020. These Orange Book eligible patents,
which provide patent protection through 2039, cover ANNOVERA and
its use for the labeled indication of preventing pregnancy in
females of reproductive potential.
“Before the issuance of the first Orange Book listable patent
for ANNOVERA, the product was protected by FDA regulatory
exclusivity through 2023 as a new chemical entity. These additional
patents, which cover different aspects of ANNOVERA, provide
independent layers of patent protection,” said Robert Finizio,
TherapeuticsMD Chief Executive Officer. “As part of our
intellectual property strategy, we continue to fortify ANNOVERA’s
patent portfolio to provide lasting durability for our flagship
product. ANNOVERA is a critical component of our drive towards
EBITDA breakeven in 2021.”
For Full Prescribing Information, including BOXED WARNING,
please visit www.annovera.com/pi.pdf.
About TherapeuticsMD
TherapeuticsMD, Inc. is an innovative, leading healthcare
company, focused on developing and commercializing novel products
exclusively for women. Our products are designed to address the
unique changes and challenges women experience through the various
stages of their lives with a therapeutic focus in family planning,
reproductive health, and menopause management. The Company is
committed to advancing the health of women and championing
awareness of their healthcare issues. To learn more about
TherapeuticsMD, please visit www.therapeuticsmd.com or follow us on
Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.
Forward-Looking Statements for TherapeuticsMD Inc.
This press release by TherapeuticsMD, Inc. may contain
forward-looking statements. Forward-looking statements may include,
but are not limited to, statements relating to TherapeuticsMD’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 press release are made as of the date of this
press release, 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 following: the effects of the COVID-19 pandemic; the company’s
ability to maintain or increase sales of its products; the
company’s ability to develop and commercialize IMVEXXY®, ANNOVERA®,
and BIJUVA® and obtain additional financing necessary therefor;
whether the company will be able to comply with the covenants and
conditions under its term loan facility; the potential of adverse
side effects or other safety risks that could adversely affect the
commercialization of the company’s current or future approved
products or preclude the approval of the company’s future drug
candidates; whether the FDA will approve the efficacy supplement
for the lower dose of BIJUVA; the company’s ability to protect its
intellectual property, including with respect to the Paragraph IV
notice letters the company received regarding IMVEXXY and BIJUVA;
the length, cost and uncertain results of future clinical trials;
the company’s reliance on third parties to conduct its
manufacturing, research and development and clinical trials; the
ability of the company’s licensees to commercialize and distribute
the company’s products; the ability of the company’s marketing
contractors to market ANNOVERA; the availability of reimbursement
from government authorities and health insurance companies for the
company’s products; the impact of product liability lawsuits; the
influence of extensive and costly government regulation; the
volatility of the trading price of the company’s common stock and
the concentration of power in its stock ownership. PDF copies of
the company’s historical press releases and financial tables can be
viewed and downloaded at its website: www.therapeuticsmd.com/pressreleases.aspx.
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version on businesswire.com: https://www.businesswire.com/news/home/20200909005861/en/
Nichol Ochsner Vice President, Investor Relations 561-961-1900,
ext. 2088 Nochsner@TherapeuticsMD.com
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