08:27 AM EDT, 06/05/2024 (MT Newswires) -- Axsome Therapeutics ( AXSM ) said Wednesday it has settled patent litigation with Unichem Laboratories regarding Axsome's sleep disorder drug Sunosi.
The pharmaceutical company said the litigation, pending in the United States District Court for the District of New Jersey, arose after Unichem applied for the US Food and Drug Administration's approval to market a generic version of Sunosi in the US.
The settlement allows Unichem to sell its generic version starting June 30, 2042, or earlier under specific conditions, with a possible extension for pediatric exclusivity, Axsome said. The companies still must submit the settlement agreement to the US Federal Trade Commission and US Department of Justice for review.
Axsome also said similar patent lawsuits against other entities are still ongoing in the New Jersey District Court.
Unichem Laboratories did not immediately respond to a request for comment from MT Newswires.
Shares of the company were down 2.6% in recent Wednesday premarket activity.
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