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Amneal Announces the Approval and Launch of Generic Revatio® for Oral Suspension and Generic Amicar® Tablets

BRIDGEWATER, N.J.--(BUSINESS WIRE)--

- Company granted 180 days of exclusivity under FDA Competitive Generic Therapy approval pathway for Generic Amicar -

Amneal Pharmaceuticals, Inc. (AMRX), today announced that it has received final U.S. Food and Drug Administration (“FDA”) approval on its Abbreviated New Drug Applications (“ANDA”) for generic versions of Revatio® (sildenafil citrate) for Oral Suspension 10 mg/ml and Amicar® (aminocaproic acid) Tablets USP, 500 mg. Amneal has immediately initiated commercialization activities.

“We are pleased to bring these important medications to patients and healthcare providers,” said Chintu Patel, Co-CEO of Amneal. “Our large and diverse pipeline has now delivered 36 new generic products to the market in 2019 across numerous dosage forms.”

Amneal was previously granted a Competitive Generic Therapy (“CGT”) designation for its generic version of Amicar® by the FDA. As the first approved application, Amneal has been granted 180 days of CGT exclusivity.

According to IQVIA™, U.S market annual sales for the 12 months ended September 30, 2019, for sildenafil citrate oral suspension and aminocaproic acid 500 mg tablets were estimated to be approximately $180 million and $23 million, respectively.

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 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 versions of Revatio® and Amicar®; 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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