Amneal Launches Generic Butrans Following ANDA Approval by FDA


The FDA granted Amneal Pharmaceuticals for a generic version of buprenorphine (Butrans) transdermal system as well as a Competitive Generic Therapy designation.

Amneal Pharmaceuticals, Inc today announced that it has received Abbreviated New Drug Application (ANDA) approval from the US 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:

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