Teva Announces Launch of an Authorized Generic of Epiduo® Forte Gel (adapalene and benzoyl peroxide gel 0.3%/2.5%), in the U.S.
02 December 2021 - 12:00AM
Business Wire
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), today announced the launch
of an authorized generic of Epiduo®1 Forte Gel (adapalene and
benzoyl peroxide gel 0.3%/2.5%), in the United States.
Adapalene and benzoyl peroxide gel 0.3%/2.5% is a topical
prescription medicine used to treat acne vulgaris.
“The launch of our first-to-market authorized generic version of
Epiduo® Forte Gel in the U.S. provides patients with another
important treatment option,” said Christine Baeder, SVP, Chief
Operating Officer US Generics, Teva USA. “Continuing to advance and
launch much-needed generic drugs is critical to ensuring access to
quality medicines to everyone who needs them."
With nearly 550 generic medicines available, Teva has the
largest portfolio of FDA-approved generic products on the market,
and holds the leading position in first-to-file opportunities, with
approximately 100 pending first-to-files in the U.S. Currently, 1
in 11 generic prescriptions dispensed in the U.S. is filled with a
Teva generic product.
Epiduo® Forte Gel had annual sales of $253 million in the U.S.,
according to IQVIA data, as of September 2021.
IMPORTANT SAFETY INFORMATION
Adapalene and Benzoyl Peroxide gel is for use on the skin only
(topical). Do not use Adapalene and Benzoyl Peroxide gel in or on
your mouth, eyes, or vagina.
Before using Adapalene and Benzoyl Peroxide gel, tell your
doctor about all of your medical conditions, including if
you:
- Have other skin problems, including cuts or sunburn
- Are pregnant or plan to become pregnant. It is not known if
Adapalene and Benzoyl Peroxide gel can harm your unborn baby. Talk
to your doctor if you are pregnant or plan to become pregnant.
- Are breastfeeding or plan to breastfeed. It is not known if
Adapalene and Benzoyl Peroxide gel passes into your breast milk and
if it can harm your baby. Talk to your doctor about the best way to
feed your baby if you use Adapalene and Benzoyl Peroxide gel.
Tell your doctor about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal
supplements. Using other topical acne products may increase the
irritation of your skin when used with Adapalene and Benzoyl
Peroxide gel.
What should I avoid while using Adapalene and Benzoyl
Peroxide gel?
- Avoid spending time in sunlight or artificial sunlight, such as
tanning beds or sunlamps. Adapalene and Benzoyl Peroxide gel can
make your skin sensitive to sun and the light from tanning beds and
sunlamps. Use sunscreen and wear a hat and clothes that cover the
areas treated with Adapalene and Benzoyl Peroxide gel if you have
to be in sunlight.
- Cold weather and wind may irritate skin treated with Adapalene
and Benzoyl Peroxide gel.
- Avoid applying Adapalene and Benzoyl Peroxide gel to cuts,
abrasions, and sunburned skin.
- Avoid skin products that may dry or irritate your skin such as
medicated or harsh soaps, astringents, cosmetics that make your
skin dry, and products containing high levels of alcohol, spices,
or limes.
- Avoid the use of “waxing” as a hair removal method on skin
treated with Adapalene and Benzoyl Peroxide gel.
- Adapalene and Benzoyl Peroxide gel may bleach your clothes or
hair. Allow Adapalene and Benzoyl Peroxide gel to dry completely
before dressing to prevent bleaching of your clothes.
What are the possible side effects of Adapalene and Benzoyl
Peroxide gel?
Adapalene and Benzoyl Peroxide gel may cause serious side
effects including:
Local skin reactions. Local skin reactions are most
likely to happen during the first 4 weeks of treatment and usually
lessen with continued use of Adapalene and Benzoyl Peroxide gel.
Signs and symptoms of local skin reactions include redness,
scaling, dryness, stinging, or burning.
Tell your doctor right away if these side effects continue for
longer than 4 weeks or get worse, you may have to stop using
Adapalene and Benzoyl Peroxide gel.
These are not all the possible side effects of Adapalene and
Benzoyl Peroxide gel. Call your doctor for medical advice about
side effects. You are encouraged to report side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
Please read the Patient Information Leaflet in the full
Prescribing Information.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic and
specialty medicines with a portfolio consisting of over 3,500
products in nearly every therapeutic area. Around 200 million
people around the world take a Teva medicine every day, and are
served by one of the largest and most complex supply chains in the
pharmaceutical industry. Along with our established presence in
generics, we have significant innovative research and operations
supporting our growing portfolio of specialty and biopharmaceutical
products. Learn more at www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, which are based on management’s current beliefs and
expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements. You
can identify these forward-looking statements by the use of words
such as “should,” “expect,” “anticipate,” “estimate,” “target,”
“may,” “project,” “guidance,” “intend,” “plan,” “believe” and other
words and terms of similar meaning and expression in connection
with any discussion of future operating or financial performance.
Important factors that could cause or contribute to such
differences include risks relating to the development, approval and
commercialization of our generic products; our ability to
successfully compete in the marketplace, including: that we are
substantially dependent on our generic products, consolidation of
our customer base and commercial alliances among our customers,
delays in launches of new generic products, the increase in the
number of competitors targeting generic opportunities and seeking
U.S. market exclusivity for generic versions of significant
products, our ability to develop and commercialize additional
pharmaceutical products, and the effectiveness of our patents and
other measures to protect our intellectual property rights; our
substantial indebtedness; our business and operations in general,
including uncertainty regarding the COVID-19 pandemic and its
impact on our business, financial condition, operations, cash
flows, and liquidity and on the economy in general; our ability to
successfully execute and maintain the activities and efforts
related to the measures we have taken or may take in response to
the COVID-19 pandemic and associated costs therewith; costs and
delays resulting from the extensive pharmaceutical regulation to
which we are subject or delays in governmental processing time due
to travel and work restrictions caused by the COVID-19 pandemic;
the effects of reforms in healthcare regulation and reductions in
pharmaceutical pricing, reimbursement and coverage; significant
sales to a limited number of customers; our ability to successfully
bid for suitable acquisition targets or licensing opportunities, or
to consummate and integrate acquisitions; and our prospects and
opportunities for growth if we sell assets; compliance, regulatory
and litigation matters, including failure to comply with complex
legal and regulatory environments; other financial and economic
risks; and other factors discussed in our Annual Report on Form
10-K for the year ended December 31, 2020, including in the section
captioned “Risk Factors.” Forward-looking statements speak only as
of the date on which they are made, and we assume no obligation to
update or revise any forward-looking statements or other
information contained herein, whether as a result of new
information, future events or otherwise. You are cautioned not to
put undue reliance on these forward-looking statements.
1 Epiduo® Forte is a registered trademark of Galderma
Laboratories, L.P
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