Teva Announces the Launch of a Generic Version of Delzicol® (mesalamine) Delayed-Release Capsules in the United States

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced the launch of a generic version of Delzicol®1
(mesalamine) delayed-release capsules, 400 mg, in the U.S.

Mesalamine Delayed-Release Capsules are an aminosalicylate indicated for
the treatment of mildly to moderately active ulcerative colitis in
patients 5 years of age and older, and for the maintenance of remission
of ulcerative colitis in adults.

Teva EVP and Head of North America Commercial, Brendan O’Grady said,
“Ulcerative colitis is a chronic inflammatory bowel disease and we’re
proud to provide another treatment option for patients.”

Mesalamine Delayed-Release Capsules further enhance Teva’s
already-comprehensive portfolio of medicines to treat gastrointestinal
disorders. 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

Delzicol® delayed-release capsules have annual sales of
approximately $130 million in the U.S., according to IMS data as of
February 2019.

About Mesalamine Delayed-Release Capsules

Mesalamine Delayed-Release Capsules are indicated for the treatment of
mildly to moderately active ulcerative colitis in patients 5 years of
age and older and for the maintenance of remission of ulcerative colitis
in adults.

Important Safety Information

Mesalamine Delayed-Release Capsules are contraindicated in patients with
known or suspected hypersensitivity to salicylates or aminosalicylates
or to any of the ingredients of Mesalamine Delayed-Release Capsules.

Renal impairment, including minimal change nephropathy, acute and
chronic interstitial nephritis, and renal failure, has been reported in
patients taking products that contain mesalamine or are converted to
mesalamine. Mesalamine has been associated with an acute intolerance
syndrome that may be difficult to distinguish from an exacerbation of
ulcerative colitis. Hypersensitivity reactions have been reported in
patients taking sulfasalazine. Some patients may have a similar reaction
to mesalamine or to other compounds that contain or are converted to
mesalamine. There have been reports of hepatic failure in patients with
preexisting liver disease who have been administered mesalamine.

The most common adverse reactions (≥ 5%) in clinical trials were
eructation, abdominal pain, constipation, dizziness, rhinitis, back
pain, and rash in adults; and nasopharyngitis, headache, abdominal pain,
dizziness, sinusitis, rash, cough, and diarrhea in pediatrics.

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) or,
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 35,000 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

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 generic version of
®, 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 uncertainty of the commercial success of our generic version of
    mesalamine, including due to a potential launch of an authorized
    generic version;
  • 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 Delzicol® is a registered trademark of Allergan
Pharmaceuticals International Limited.


IR Contacts
United States
Kevin C. Mannix

Ran Meir
(215) 591-3033

PR Contacts
United States
Kelley Dougherty

Yonatan Beker
972 (54) 888 5898

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