Alkermes settles with Amneal over opioid dependence treatment

Biopharmaceutical company  Alkermes has entered into a settlement and licence agreement with generic maker  Amneal Pharmaceuticals to resolve an inter partes review (IPR).

In an  announcement made on Monday, July 29, Alkermes said that the parties agreed to request the termination of the IPR petition challenging US patent number 7,919,499.

The’499 patent, called “Naltrexone long-acting formulations and methods of use”, is an Orange Book-listed patent for Vivitrol which expires in 2029. Vivitrol is used to manage alcohol or opioid dependence.

Under the agreement, Alkermes has granted Amneal the non-exclusive right to market a generic formulation of Vivitrol (naltrexone for extended-release injectable suspension) beginning sometime in 2028, or earlier under certain circumstances.

Amneal submitted its IPR petition back in April last year, and the Patent Trial and Appeal Board (PTAB) instituted the review in November.

An oral hearing with the PTAB, which was scheduled to take place on July 29, was cancelled by the board in light of this settlement.

Richard Pops, CEO of Alkermes, said: “We believe this settlement recognises the strength of the Vivitrol IP. We are pleased to come to this resolution which provides more clarity regarding the outlook for Vivitrol.”

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