Teva Announces Launch of an Authorized Generic of Flector® Patch (diclofenac epolamine topical patch) in the United States

JERUSALEM–(BUSINESS WIRE)–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.


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)
. 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
or Teva’s Public Relations or Investor Relations contacts.

About Teva

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

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®
  • 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.


IR Contacts
United States
Kevin C. Mannix, (215)
Ran Meir, 972 (3) 926-7516

PR Contacts
United States
Kelley Dougherty,
(973) 658-0237
Yonatan Beker, 972 (54) 888 5898

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