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Amneal Announces the Approval and Launch of Generic Carafate®

BRIDGEWATER, NJ.--(BUSINESS WIRE)--

Amneal Pharmaceuticals, Inc. (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. (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,” “estimate,” “assume,” “continue,” and similar words are intended to 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.

Trademarks referenced herein are the property of their respective owners.

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