FDAnews Drug Daily Bulletin
Pharmaceuticals / Commercial Operations

Alkermes Grants Amneal Generic Rights for Vivitrol

Aug. 5, 2019
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Irish drugmaker Alkermes has entered into a settlement and license agreement with American generics company Amneal in order to end the generics maker’s inter partes review of a Vivitrol (naltrexone for extended-release injectable suspension) patent.

The deal wraps up Amneal’s challenge of the patent and grants the company the non-exclusive right to manufacture and market a generic version of the narcotic and alcohol addiction treatment in the U.S. “sometime in 2028 or earlier under certain circumstances,” Alkermes said.

While there are additional terms to the agreement, they remain confidential. Alkermes’ patent in question is set to expire in 2029.

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