Teva Announces Launch of First Generic Version of AZOPT® (brinzolamide ophthalmic suspension) 1%, used to treat high pressure inside the eye, in the United States

Rhea-AI Summary

Teva Pharmaceuticals USA has launched the first generic version of AZOPT (brinzolamide ophthalmic suspension) 1%, approved by the FDA to treat ocular hypertension and open-angle glaucoma. This product provides patients with an affordable treatment option, with annual U.S. sales over $184 million. Teva holds the largest FDA-approved generic portfolio, with nearly 550 products available. This launch demonstrates Teva's commitment to expanding access to essential medicines while maintaining a leading position in the generics market.

Positive

• Launch of the first generic version of AZOPT, enhancing treatment options for patients.
• Annual sales of AZOPT exceed $184 million, representing significant market potential.
• Teva has the largest portfolio of FDA-approved generic drugs, with nearly 550 products.

Negative

• The commercial success of the generic AZOPT may be impacted by competition in the generics market.

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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FAQ

When did Teva launch the generic version of AZOPT?

Teva launched the first generic version of AZOPT on March 8, 2021.

What is the annual sales figure for AZOPT in the U.S.?

AZOPT has annual sales of over $184 million in the U.S.

What conditions does brinzolamide ophthalmic suspension treat?

Brinzolamide ophthalmic suspension treats ocular hypertension and open-angle glaucoma.

How many generic medicines does Teva offer?

Teva offers nearly 550 FDA-approved generic medicines.

What is the significance of Teva's launch of generic AZOPT?

The launch provides patients with an affordable treatment option for managing eye pressure.