Axsome Therapeutics (AXSM) said Wednesday it has reached a settlement with Hikma Pharmaceuticals resolving a patent dispute over its treatment Sunosi (solriamfetol.)
The dispute arose after Hikma filed an abbreviated new drug application seeking Food and Drug Administration approval to produce a generic version of Sunosi, the company said.
As part of the agreement, Axsome said it will grant Hikma a license to launch its generic version no earlier than March 1, 2040, or Sept. 1, 2040, if pediatric exclusivity is granted, pending regulatory approval.
Axsome said the settlement will be submitted for review by the US Federal Trade Commission and the Department of Justice.
The company said similar patent litigation against other parties related to Sunosi remains pending in the US District Court for the District of New Jersey.
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