PatentJun 3, 2026, 09:11 AM
Axsome Therapeutics Settles All SUNOSI Patent Litigation
AI Summary
Axsome Therapeutics announced the resolution of all patent litigation concerning its product SUNOSI (solriamfetol). The company settled with the last remaining first-to-file generic applicant, granting five companies the right to market generic versions of SUNOSI. Generic sales are permitted to commence on or after September 1, 2040, if pediatric exclusivity is secured, or March 1, 2040, if not. The agreement will undergo review by the U.S. Federal Trade Commission and the U.S. Department of Justice.
Key Highlights
- Axsome Therapeutics resolved all patent litigation related to its product SUNOSI (solriamfetol).
- The settlement was reached with the only remaining first-to-file generic applicant.
- Five companies are granted the right to sell generic versions of SUNOSI.
- Generic sales can begin on or after September 1, 2040, if pediatric exclusivity is granted.
- Generic sales can begin on or after March 1, 2040, if no pediatric exclusivity is granted.
- The settlement agreement will be submitted to the U.S. Federal Trade Commission and U.S. Department of Justice.
Price Impact
More from AXSM