Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced the launch of an authorized generic of Flector®1 Patch, 1.3 %, in the U.S.
Diclofenac Epolamine Topical Patch, 1.3%, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the topical treatment of acute pain due to minor strains, sprains and contusions.
“The launch of our authorized generic of Flector® Patch in the U.S. is an important addition to Teva’s portfolio of over 40 generic pain management medicines,” said Brendan O’Grady, EVP and Head of North America Commercial.
With nearly 500 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 over 100 pending first-to-files in the U.S. Currently, one in eight generic prescriptions dispensed in the U.S. is filled with a Teva generic product. With the launch of Diclofenac Epolamine Topical Patch, 1.3%, Teva now has over 16 medicines in the Analgesics and Antipyretics, Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) therapeutic area in the U.S.
Flector® Patch had annual sales of $123 million in the U.S., according to IQVIA data as of December 2018.
About Diclofenac Epolamine Topical Patch, 1.3%
Diclofenac Epolamine Topical Patch, 1.3% is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.
IMPORTANT SAFETY INFORMATION
WARNING: NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Diclofenac Epolamine Topical Patch, 1.3% is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
Diclofenac Epolamine Topical Patch, 1.3% is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product. Diclofenac Epolamine Topical Patch, 1.3% is contraindicated in patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients. Diclofenac Epolamine Topical Patch, 1.3% is contraindicated for use on non-intact or damaged skin resulting from any etiology, including, exudative dermatitis, eczema, infected lesions, burns, or wounds.
The following serious adverse reactions are also associated with the use of NSAIDs, including diclofenac: hepatotoxicity; new onset or worsening of hypertension; heart failure; fluid retention; edema; renal toxicity; hyperkalemia; anaphylactic reactions; exacerbation of aspirin-sensitive asthma; serious skin reactions, such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN); premature closure of fetal ductus arteriosus; anemia; and increased risk of bleeding events. Concomitant use of oral and topical NSAIDs may result in a higher rate of hemorrhage, and more frequent abnormal creatinine, urea and hemoglobin.
In controlled clinical trials, the most common adverse reactions for Diclofenac Epolamine Topical Patch, 1.3% and placebo patch were application site reactions, occurring in 11% and 12% of patients, respectively. Gastrointestinal disorders were reported for Diclofenac Epolamine Topical Patch, 1.3% and placebo patch in 9% and 6% of patients, respectively.
For more information, please see accompanying Full Prescribing Information, including the Boxed Warning. A copy may be requested from Teva US Medical Information at 888-TEVA-USA (888-838-2872), firstname.lastname@example.org, or Teva’s Public Relations or Investor Relations contacts.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global leader in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory. We deliver high-quality generic products and medicines in nearly every therapeutic area to address unmet patient needs. We have an established presence in generics, specialty, OTC and API, building on more than a century-old legacy, with a fully integrated R&D function, strong operational base and global infrastructure and scale. We strive to act in a socially and environmentally responsible way. Headquartered in Israel, with production and research facilities around the globe, we employ 45,000 professionals, committed to improving the lives of millions of patients. 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 and potential benefits of the authorized generic of Flector® Patch, 1.3 %, 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:
- commercial success of the authorized generic version of Flector® Patch;
- our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; competition for our specialty products, especially COPAXONE®, our leading medicine, which faces competition from existing and potential additional generic versions and orally-administered alternatives; the uncertainty of commercial success of AJOVY® or AUSTEDO®; competition from companies with greater resources and capabilities; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations; consolidation of our customer base and commercial alliances among our customers; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; price erosion relating to our products, both from competing products and increased regulation; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; our ability to take advantage of high-value opportunities; the difficulty and expense of obtaining licenses to proprietary technologies; 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: failure to effectively execute our restructuring plan announced in December 2017; uncertainties related to, and failure to achieve, the potential benefits and success of our new senior management team and organizational structure; harm to our pipeline of future products due to the ongoing review of our R&D programs; our ability to develop and commercialize additional pharmaceutical products; potential additional adverse consequences following our resolution with the U.S. government of our FCPA investigation; compliance with sanctions and other trade control laws; manufacturing or quality control problems, which may damage our reputation for quality production and require costly remediation; interruptions in our supply chain; disruptions of our or third party information technology systems or breaches of our data security; the failure to recruit or retain key personnel; variations in intellectual property laws that may adversely affect our ability to manufacture our products; challenges associated with conducting business globally, including adverse effects of political or economic instability, major hostilities or terrorism; significant sales to a limited number of customers in our U.S. market; 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: costs and delays resulting from the extensive governmental regulation to which we are subject; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; governmental investigations into selling and marketing practices; potential liability for patent infringement; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; 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 our Annual Report on Form 10-K for the year ended December 31, 2018, including the sections thereof 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.
1 Flector® is a registered trademark of IBSA Institute Biochimique SA, licensed by Alpharma Pharmaceuticals LLC, a subsidiary of Pfizer Inc.