Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva
Pharmaceutical Industries Ltd.(NYSE and TASE: TEVA), today
announced its launch of the first available generic version of
AZOPT® (brinzolamide ophthalmic suspension) 1%, approved by the US
Food and Drug Administration to treat high pressure inside the eye
due to ocular hypertension and open-angle glaucoma. Brinzolamide
ophthalmic suspension 1% works by decreasing the amount of fluid
within the eye.
“This first-to-market generic version of AZOPT® (brinzolamide
ophthalmic suspension) 1% in the U.S. provides patients with
another important treatment option,” said Christine Baeder, SVP,
Chief Operating Officer US Generics, Teva USA. “Continuing to
pursue 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, one
in ten generic prescriptions dispensed in the U.S. is filled with a
Teva generic product.
Brinzolamide ophthalmic suspension 1% has annual sales of more
than $184 million in the U.S., according to IQVIA data as of
December, 2020.
About Brinzolamide ophthalmic suspension 1%
Brinzolamide ophthalmic suspension 1% is a prescription medicine
used to treat elevated pressure within the eye in people with
ocular hypertension or open-angle glaucoma.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
brinzolamide ophthalmic suspension 1%?
Brinzolamide ophthalmic suspension 1% should not be used by
anyone who is hypersensitive to any ingredient in this
product.
Brinzolamide ophthalmic suspension 1% is a sulfonamide and
side effects attributed to sulfonamides may occur with use of this
product. Death, while rare, has occurred with the use of this
product and was attributed to severe skin, liver, and blood
reactions. Any unusual eye or bodily reactions or signs of
sensitivity should be reported to your physician and you should
discontinue using brinzolamide ophthalmic suspension 1%.
Brinzolamide ophthalmic suspension 1% can cause swelling in the
cornea and caution should be taken when used by people with low
endothelial cell counts. Brinzolamide ophthalmic suspension 1% is
not recommended in people with severe kidney impairment.
Brinzolamide ophthalmic suspension 1% has not been studied in
patients with acute angle-closure glaucoma.
Contact lenses should be removed prior to using brinzolamide
ophthalmic suspension 1%. Lenses can be reinserted 15 minutes after
use.
What should I tell my doctor before taking brinzolamide
ophthalmic suspension 1%?
Tell your doctor if you are pregnant, plan to become pregnant,
or are breast-feeding. If you become pregnant while taking
brinzolamide ophthalmic suspension 1%, call your doctor.
What are the possible side effects of brinzolamide ophthalmic
suspension 1%?
The most frequently reported side effects were blurred vision
and bitter, sour or unusual taste. Other side effects included
inflammation of the eyelids, dermatitis, dry eye, sensation of a
foreign object in the eye, headache, red eye, discharge from the
eye, eye discomfort, inflammation of the cornea, eye pain, itchy
eyes, and inflammation of the nose.
Tell your doctor if you have any side effect that bothers you or
that does not go away. These are not all the possible side effects
of brinzolamide ophthalmic suspension 1%. 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.
For more information, please see accompanying full Prescribing
Information. A copy may be requested from Teva U.S. Medical
Information at 888-TEVA-USA (888-838-2872), druginfo@tevapharm.com,
or Teva’s Public Relations or Investor Relations contacts.
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
regarding the launch of our generic version of NuvaRing®
(etonogestrel and ethinyl estradiol) vaginal ring in the United
States, 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.
Important factors that could cause or contribute to such
differences include risks relating to:
- the commercial success of our generic version of AZOPT®
(brinzolamide ophthalmic suspension) 1%;
- 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 biopharmaceutical products; competition for our
specialty products, including AUSTEDO®, AJOVY® and COPAXONE®; our
ability to achieve expected results from investments in our product
pipeline; 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, which may limit our ability to
incur additional indebtedness, engage in additional transactions or
make new investments, may result in a further downgrade of our
credit ratings; and our inability to raise debt or borrow funds in
amounts or on terms that are favorable to us;
- our business and operations in general, including: uncertainty
regarding the magnitude, duration, and geographic reach of 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; effectiveness of our optimization efforts; our ability
to attract, hire and retain highly skilled personnel; manufacturing
or quality control problems; interruptions in our supply chain;
disruptions of information technology systems; breaches of our data
security; variations in intellectual property laws; challenges
associated with conducting business globally, including political
or economic instability, major hostilities or terrorism; 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;
increased legal and regulatory action in connection with public
concern over the abuse of opioid medications and our ability to
reach a final resolution of the remaining opioid-related
litigation; scrutiny from competition and pricing authorities
around the world, including our ability to successfully defend
against the U.S. Department of Justice criminal charges of Sherman
Act violations; potential liability for patent infringement;
product liability claims; failure to comply with complex Medicare
and Medicaid reporting and payment obligations; compliance with
anti-corruption sanctions and trade control laws; and environmental
risks;
- other financial and economic risks, including: our exposure to
currency fluctuations and restrictions as well as credit risks;
potential impairments of our intangible assets; potential
significant increases in tax liabilities; and the effect on our
overall effective tax rate of the termination or expiration of
governmental programs or tax benefits, or of a change in our
business;
and other factors discussed in this press release and in our
Annual Report on Form 10-K for the year ended December 31, 2020,
including in the sections captioned "Risk Factors” and “Forward
Looking Statements.” 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210308005815/en/
IR Contacts United States Kevin C. Mannix (215)
591-8912
Israel Yael Ashman 972 (3) 914-8262
PR Contacts United States Kelley Dougherty (973)
658-0237
Israel Yonatan Beker 972 (54) 888 5898
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