Amneal Announces the Approval and Launch of Generic Carafate®
December 03 2019 - 8:00AM
Business Wire
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), today
announced that it has received final U.S. Food and Drug
Administration approval on its Abbreviated New Drug Application for
a generic version of Carafate® (sucralfate) Oral Suspension, 1 g/10
ml. Amneal has immediately initiated commercialization
activities.
“We are proud to announce our approval for the first generic
Sucralfate Oral Suspension, one of the 15 complex products we
expect to launch over an 18 to 24-month period,” said Chirag and
Chintu Patel, Co-Chief Executive Officers. “Developing the first
generic version of a drug involves significant technical
complexity, and this approval underscores Amneal’s ability to set
itself apart. We remain excited about the additional, high-value
opportunities in our pipeline and are committed to delivering
affordable generic products to our patients. With a diverse and
strong generics and specialty portfolio, along with our commitment
to operational excellence, we expect to return to growth and drive
meaningful value for stakeholders in 2020 and beyond.”
According to IQVIA™, U.S market annual sales for the 12 months
ended October 31, 2019, for sucralfate oral suspension was
estimated to be approximately $285 million.
About Amneal
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in
Bridgewater, NJ, is an integrated pharmaceutical company focused on
developing, manufacturing and distributing generic, brand and
biosimilar products. The Company has operations in North America,
Asia, and Europe, working together to bring high-quality medicines
to patients primarily within the United States.
Amneal has an extensive portfolio of more than 300 generic
medicines and is expanding its portfolio to include complex dosage
forms in a broad range of therapeutic areas. The Company also
markets a portfolio of branded pharmaceutical products through its
Specialty segment focused principally on central nervous system
disorders, endocrinology and parasitic infections. For more
information, visit www.amneal.com.
Safe Harbor Statement
Certain statements contained herein, regarding matters that are
not historical facts, may be forward-looking statements (as defined
in the Private Securities Litigation Reform Act of 1995). Such
forward-looking statements include statements regarding
management’s intentions, plans, beliefs, expectations or forecasts
for the future, including, among other things, future operating
results and financial performance, product development and
launches, integration strategies and resulting cost reduction,
market position and business strategy. Words such as “may,” “will,”
“could,” “expect,” “plan,” “anticipate,” “intend,” “believe,”
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identify estimates and forward-looking statements.
The reader is cautioned not to rely on these forward-looking
statements. These forward-looking statements are based on current
expectations of future events. If the underlying assumptions prove
inaccurate or known or unknown risks or uncertainties materialize,
actual results could vary materially from the expectations and
projections of Amneal Pharmaceuticals, Inc. (the “Company”). Such
risks and uncertainties include, but are not limited to: the
commercial success of our generic version of Carafate®; our ability
to successfully develop and commercialize new products; the
competition we face in the pharmaceutical industry from brand and
generic drug product companies, and the impact of that competition
as well as consolidation of institutional buyers and payers on our
ability to set prices; our dependence on the sales of a limited
number of products for a substantial portion of our total revenues;
the risk of product liability and other claims against us by
consumers and other third parties; the impact of healthcare reform
and changes in coverage and reimbursement levels by governmental
authorities and other third-party payers; the continuing trend of
consolidation of certain customer groups; our dependence on third
party suppliers and distributors for raw materials for our products
and certain finished goods; the impact of global economic
conditions; and legal, regulatory and legislative efforts by our
brand competitors to deter competition from our generic
alternatives. A further list and descriptions of these risks,
uncertainties and other factors can be found in the Company’s most
recently filed Annual Report on Form 10-K for the fiscal year ended
December 31, 2018, as supplemented by any subsequently filed
Quarterly Reports on Form 10-Q. Copies of these filings are
available online at www.sec.gov, www.amneal.com or on request from
the Company.
Forward-looking statements included herein speak only as of the
date hereof and we undertake no obligation to revise or update such
statements to reflect the occurrence of events or circumstances
after the date hereof.
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respective owners.
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Mark Donohue (908) 409-6718
Amneal Pharmaceuticals (NYSE:AMRX)
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