Axsome Therapeutics, Inc. entered into a settlement agreement with Alkem Laboratories Ltd. resolving patent litigation over SUNOSI® (solriamfetol) in the U.S. District Court for the District of New Jersey. The agreement grants Alkem a license to sell its generic version starting on or after September 1, 2040 (with pediatric exclusivity) or March 1, 2040 (without), subject to FDA approval and customary conditions.
Key takeaways
Settlement with Alkem Laboratories Ltd. resolves SUNOSI® patent litigation.
Litigation stemmed from Alkem's Abbreviated New Drug Application for generic SUNOSI.
Generic entry allowed on or after September 1, 2040 if pediatric exclusivity granted.
Generic entry allowed on or after March 1, 2040 if no pediatric exclusivity.
Settlement subject to review by U.S. Federal Trade Commission and U.S. Department of Justice.
Similar SUNOSI litigation against another party remains pending.