Axsome Settles All SUNOSI Patent Litigation, Delaying Generic Entry Until 2040

Axsome Therapeutics announced it has resolved all patent litigation for its product SUNOSI® (solriamfetol). The settlement agreements with five generic drug manufacturers were made in response to their applications to market generic versions of the drug in the U.S.

Key Details

• Agreement Terms: Axsome has granted five companies the right to sell generic versions of SUNOSI, subject to FDA approval.
• Generic Entry Date: Generic versions can be sold starting on or after March 1, 2040.
• Potential Extension: The generic entry date will be extended to September 1, 2040, if pediatric exclusivity is granted for SUNOSI.
• Resolution: This settlement resolves all pending patent litigation related to SUNOSI.