Axsome Therapeutics Settles Patent Litigation for Sunosi

By Bobby Samwell • Wednesday, June 03 16:03 • Permanent Link

Axsome Therapeutics said it has settled all remaining patent litigation tied to Sunosi, ending the legal fight over generic entry for the wakefulness drug.

Under the agreement, five companies will be allowed to launch generic versions of Sunosi beginning on or after Sept. 1, 2040, if pediatric exclusivity is granted, or on or after March 1, 2040, if it is not. Those dates are subject to FDA approval and standard conditions and exceptions.

The company said no other Sunosi patent litigation remains pending. The settlement resolves the last outstanding case with the only remaining first-to-file generic applicant. Axsome said it will submit the agreement to the Federal Trade Commission and the Justice Department for review, as required by law. Today the company's shares have moved 4.25% to a price of $231.60. For more information, read the company's full 8-K submission here.

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