Zydus Cadila division settles patent litigation with Adamas Pharma over dyskinesia drug Gocovri
New Delhi: The US generic drug division of Zydus Cadila Healthcare, Zydus Pharmaceuticals (USA) Inc., and Zydus Worldwide DMCC recently entered into a settlement agreement with Adamas Pharmaceuticals, Inc for resolving the ongoing litigation concerning Zydus's Abbreviated New Drug Application ("ANDA") seeking approval by the U.S. Food and Drug Administration to market a generic version of GOCOVRI (amantadine) extended-release capsules.
An announcement in this regard was recently made by Adamas Pharma.
Under the settlement agreement, Adamas grants Zydus a non-exclusive license to make, use, sell, offer to sell, and import generic versions of GOCOVRI as of March 4, 2030, or earlier in certain circumstances, including the potential for an accelerated license date if the unit sales of GOCOVRI in the 12-month period ending July 31, 2025, or any subsequent 12-month period decline by a specified percentage below the unit sales of GOCOVRI in the year ended December 31, 2019.
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