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Alkermes Announces Settlement With Amneal Over VIVITROL® Patent Dispute
DUBLIN, July 29, 2019 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) announced today that it has entered into a settlement and license agreement (the agreement)
About this update from Alkermes Plc
[{"type":"text","content":"DUBLIN, July 29, 2019 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) announced today that it has entered into a settlement and license agreement (the agreement) with Amneal Pharmaceuticals LLC (Amneal) to resolve Amneal's inter partes review (IPR) petition challenging U.S. Patent Number 7,919,499 ('499 Patent), an Orange Book-listed patent for VIVITROL® (naltrexone for extended-release injectable suspension) that expires in 2029. \nUnder the agreement, the parties agreed to request termination of the IPR and Alkermes granted Amneal the non-exclusive right to market a generic formulation of VIVITROL in the U.S. beginning sometime in 2028 or earlier under certain circumstances. Additional terms of the agreement are confidential. \n\"We believe this settlement recognizes the strength of the VIVITROL intellectual property. We are pleased to come to this resolution which provides more clarity regarding the outlook for VIVITROL,\" said Richard Pops, Chief Executive Officer of Alkermes. \"VIVITROL is a complex medicine that requires sophisticated manufacturing expertise and capabilities, along with nuanced commercial capabilities to successfully navigate a fragmented treatment system.\"\nAn oral hearing with the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office, that was scheduled to take place on July 29, 2019, was cancelled by the PTAB in light of this settlement.\nAbout Alkermes plcAlkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases and oncology. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction, multiple sclerosis and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.\nNote Regarding Forward-Looking Statements Certain statements set forth in this press release constitute \"forward-looking statements\" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concer...