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Axsome Reaches Settlement With Hetero Labs Over Sunosi Patent Dispute; Shares Up Pre-Bell
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Axsome Reaches Settlement With Hetero Labs Over Sunosi Patent Dispute; Shares Up Pre-Bell
May 27, 2025 5:51 AM

08:21 AM EDT, 05/27/2025 (MT Newswires) -- Axsome Therapeutics ( AXSM ) said Tuesday it reached a settlement with Hetero Labs over patent litigation concerning Sunosi, its treatment for excessive daytime sleepiness.

The deal allows Hetero to launch a generic version of Sunosi in the US no earlier than March 1, 2040, or Sept. 1, 2040 if pediatric exclusivity is granted, pending regulatory approval, the company said.

The litigation stemmed from Hetero's application to the Food and Drug Administration to sell a generic version of the drug, Axsome said.

Axsome said the agreement will be submitted to the US Federal Trade Commission and Department of Justice for review.

Shares of the company were up 1.2% in recent premarket activity.

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