Alkermes has entered into a settlement and license agreement with Amneal Pharmaceuticals 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.
Under 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.
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"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."
An 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.