Amneal Launches Generic Butrans® Following ANDA Approval by FDAApril 16, 2020
BRIDGEWATER, N.J.–(BUSINESS WIRE)–Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for a generic version of Butrans® (buprenorphine) Transdermal System, 5 mcg/hr, 7.5 mcg/hr, 10 mcg/hr, 15 mcg/hr and 20 mcg/hr. In addition, Amneal was granted the Competitive Generic Therapy (CGT) designation and 180 days of exclusivity for the 7.5 mcg/hr dose. Amneal immediately initiated commercialization activities across all dosages for its Buprenorphine Transdermal System. Butrans is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Amneal Co-Chief Executive Officers Chirag Patel and Chintu Patel said, “Expanding our portfolio of complex generic drug products and providing patients access to affordable generic medicines will continue to set Amneal apart. Buprenorphine represents the fifth complex product approval we have achieved in the last few months and demonstrates continued progress in our shift to commercialize more complex, high-value products. Our employees have demonstrated incredible resolve in helping us achieve these milestones during an unprecedented time.”
According to IQVIA™, a leading healthcare data and analytics provider, U.S. annual sales for Butrans for the 12 months ended February 2020 were approximately $225 million.
Important Safety Information includes a boxed warning: addiction, abuse, and misuse; Risk Evaluation and Mitigation Strategy (REMS); life-threatening respiratory depression; accidental exposure; neonatal opioid withdrawal syndrome; and risks from concomitant use with benzodiazepines or other CNS depressants. See Package Insert (PI) for full prescribing information and complete boxed warning at the link below:
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) headquartered in Bridgewater, NJ, is a fully-integrated pharmaceutical company focused on the development, manufacturing and distribution of generic and specialty drug products. The Company has manufacturing 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 225 marketed commercial products and is expanding its portfolio to include complex dosage forms, including biosimilars, 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 and endocrine disorders. For more information, visit https://www.amneal.com.
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, as amended). 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. A 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, 2019, 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, except as otherwise required by United States securities laws.
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