Axsome, Hetero Settle Patent Fight on Daytime-Sleepiness Drug

May 27, 2025, 9:11 PM UTC

Axsome Therapeutics Inc. and Hetero Labs Ltd. settled their portion of a patent dispute over proposed copies of a drug treatment for daytime sleepiness, leaving two generic-drug makers in the consolidated lawsuit.

The deal, which Axsome disclosed Tuesday in a press release and regulatory filing, grants Hetero a license to launch a generic version of Sunosi in September 2040 if the US Food and Drug Administration grants pediatric exclusivity, or in March 2040 if it doesn’t. Hetero didn’t respond to requests confirming the deal, and the case docket before US District Court for the District of New Jersey didn’t ...

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