Teva Announces the U.S. Launch of its Generic Version of SOOLANTRA® (ivermectin) Cream, 1% for Once Daily Treatment of Rosacea

Rhea-AI Summary

Teva Pharmaceuticals has launched a generic version of SOOLANTRA® (ivermectin) Cream, 1% in the U.S. for treating rosacea lesions. Teva is a leader in generic medicines with over 550 FDA-approved products. SOOLANTRA® generated annual sales exceeding $115 million in the U.S. Teva emphasizes that their ivermectin cream is not intended for oral, ophthalmic, or intravaginal use, highlighting potential risks during pregnancy and breastfeeding. The company remains focused on expanding its generics portfolio amid competitive market conditions.

Positive

• Launch of generic SOOLANTRA® (ivermectin) Cream, 1% enhances Teva's product portfolio.
• SOOLANTRA® had annual U.S. sales of over $115 million, indicating significant market potential.
• Teva holds the largest portfolio of FDA-approved generic products.

Negative

• Dependence on generic products increases vulnerability to market competition.
• Substantial indebtedness may limit future investment and operational flexibility.
• Risks related to regulatory compliance and ongoing opioid litigation may affect financial stability.

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd.(NYSE and TASE: TEVA), today announced the U.S. launch of its generic version of once daily SOOLANTRA® (ivermectin) Cream, 1% for the treatment of inflammatory lesions of rosacea.

With nearly 550 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market. Currently, 1 in 11 generic prescriptions dispensed in the U.S. is filled with a Teva generic product.

SOOLANTRA® had annual sales of more than $115 million in the U.S., according to IQVIA data as of April 2021.

About Ivermectin Cream 1%

Ivermectin cream, 1% is a prescription medicine used for the treatment of inflammatory lesions of rosacea.

IMPORTANT SAFETY INFORMATION

Ivermectin cream, 1% is NOT for oral (by mouth), ophthalmic (in the eye), or intravaginal (in the vagina) use.

Pregnancy and Lactation: Ivermectin cream, 1% should be used during pregnancy only if the potential benefit outweighs any potential risk to the fetus. There is a potential for serious adverse reactions from ivermectin cream in nursing infants. A decision should be made with your doctor whether to discontinue nursing or to discontinue the drug.

Side Effects: Side effects include skin burning sensation and skin irritation. Talk to your doctor if you experience side effects and also about possible side effects that could occur. You may report side effects of prescription drugs to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Keep Ivermectin cream out of reach of children.

Please see the full Prescribing Information and Instructions for Use.

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 SOOLANTRA^® (ivermectin) Cream, 1% 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 SOOLANTRA^®(ivermectin) Cream, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210616005521/en/

FAQ

What is the significance of Teva's launch of the generic SOOLANTRA® (ivermectin) Cream, 1%?

Teva's launch of the generic version enhances its product portfolio and targets a market with over $115 million in annual sales.

How does the launch of SOOLANTRA® (ivermectin) Cream, 1% impact Teva's market position?

The launch reinforces Teva's leadership in generics, but competition in the market poses risks to its commercial success.

What are the safety precautions related to ivermectin cream?

Ivermectin cream is not for oral, ophthalmic, or intravaginal use; risks during pregnancy and nursing are highlighted.

How many generic medicines does Teva currently have available?

Teva has nearly 550 generic medicines available, making it the largest generic portfolio in the U.S.

What financial risks does Teva face following the SOOLANTRA® launch?

Teva's substantial indebtedness and regulatory compliance risks could hinder future performance and growth.