-Newly-issued patent provides U.S. patent
protection for ANNOVERA® into 2039-
TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s
healthcare company, today announced that the United States Patent
and Trademark Office (USPTO) has issued a patent that covers the
labeled indication 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. TherapeuticsMD has 30 days to
submit the formal paperwork to have this patent 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 to this patent, which provides protection through
2039, ANNOVERA contains segesterone acetate, a “new chemical
entity,” which qualifies ANNOVERA for FDA regulatory exclusivity
through August 2023 under the Hatch-Waxman Act.
"The issuance of this patent strengthens the intellectual
property protection for ANNOVERA, providing Orange Book-listed
patent protection through 2039. This is an important step in the
ongoing development of the patent portfolio for ANNOVERA,” said
TherapeuticsMD Chief Executive Officer, Robert Finizio.
About ANNOVERA
INDICATION
ANNOVERA is a progestin/estrogen combination hormonal
contraceptive indicated for use by females of reproductive
potential to prevent pregnancy.
Limitation of Use: ANNOVERA has not been adequately studied in
females with a body mass index of >29 kg/m2.
IMPORTANT SAFETY INFORMATION
WARNING: CIGARETTE SMOKING AND
SERIOUS CARDIOVASCULAR EVENTS
See full prescribing
information for complete boxed warning.
- Females over 35 years old who smoke should not use
ANNOVERA.
- Cigarette smoking increases the risk of serious
cardiovascular events from combination hormonal contraceptive
use.
CONTRAINDICATIONS
ANNOVERA is contraindicated and should not be used in women with
a high risk of arterial or venous thrombotic diseases; current or
history of breast cancer or other estrogen- or progestin-sensitive
cancer; liver tumors, acute hepatitis, or severe (decompensated)
cirrhosis; undiagnosed abnormal uterine bleeding; hypersensitivity
to any of the components of ANNOVERA; and use of Hepatitis C drug
combinations containing ombitasvir/paritaprevir/ritonavir, with or
without dasabuvir.
WARNINGS AND PRECAUTIONS
- Stop ANNOVERA if a thrombotic or thromboembolic event occurs,
and at least 4 weeks before and through 2 weeks after major
surgery. Start ANNOVERA no earlier than 4 weeks after delivery, in
females who are not breastfeeding. Consider cardiovascular risk
factors before initiating in all females, particularly those over
35 years.
- Discontinue if jaundice occurs.
- Stop ANNOVERA prior to starting therapy with the combination
drug regimen ombitasvir/paritaprevir/ritonavir. ANNOVERA can be
restarted 2 weeks following completion of this regimen.
- Do not prescribe ANNOVERA for females with uncontrolled
hypertension or hypertension with vascular disease. Monitor blood
pressure and stop use if blood pressure rises significantly in
females with well-controlled hypertension.
- Monitor glucose in pre-diabetic or diabetic females taking
ANNOVERA. Consider an alternate contraceptive method for females
with uncontrolled dyslipidemias.
- Patients using ANNOVERA who have a significant change in
headaches or irregular bleeding or amenorrhea should be evaluated.
ANNOVERA should be discontinued if indicated.
- Other warnings include: gallbladder disease; depression;
cervical cancer; increased serum concentrations of binding
globulins; hereditary angioedema; chloasma (females who tend to
develop chloasma should avoid exposure to the sun or UV radiation
while using ANNOVERA); toxic shock syndrome (TSS) (if a patient
exhibits symptoms of TSS, remove ANNOVERA, and initiate appropriate
medical treatment); vaginal use (ANNOVERA may not be suitable for
females with conditions that make the vagina more susceptible to
vaginal irritation or ulceration).
ADVERSE REACTIONS
The most common adverse reactions reported in at least 5% of
women who received ANNOVERA were: headache/migraine,
nausea/vomiting, vulvovaginal mycotic infection/candidiasis,
lower/upper abdominal pain, dysmenorrhea, vaginal discharge,
urinary tract infection, breast pain/tenderness/discomfort,
bleeding irregularities including metrorrhagia, diarrhea, and
genital pruritus.
DRUG INTERACTIONS
Drugs or herbal products that induce certain enzymes, including
CYP3A4, may decrease the effectiveness of ANNOVERA or increase
breakthrough bleeding. Counsel patients to use a back-up or
alternative method of contraception when enzyme inducers are used
with ANNOVERA.
Please note that this information is not comprehensive. For
Full Prescribing Information, including BOXED WARNING, please visit
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
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 company’s ability to protect the intellectual
property related to its products; 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®, BIJUVA® and its hormone therapy drug
candidates and obtain additional financing necessary therefor;
whether the company will be able to comply with the covenants and
conditions under its term loan facility, including the conditions
to draw an additional tranche thereunder and whether the lender
will make such tranche available; 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200429005171/en/
Investor Contact Nichol
Ochsner Vice President, Investor Relations 561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com
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