Axsome Therapeutics has announced the resolution of all remaining patent litigation related to its wake-promoting medicine SUNOSI (solriamfetol), bringing an end to a series of legal disputes with generic drug manufacturers seeking U.S. market entry.
The settlement was reached with the final first-to-file generic applicant involved in the litigation. Under the agreement, Axsome will grant licenses to five generic companies to market generic versions of SUNOSI beginning on or after March 1, 2040, or September 1, 2040 if the product receives pediatric exclusivity, subject to FDA approval and customary conditions.
With this agreement, Axsome stated that no SUNOSI-related patent litigation remains pending, providing long-term clarity for the product’s intellectual property protection and future commercialization strategy.
The company will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review, as required under U.S. law.
SUNOSI is approved in the United States to improve wakefulness in adults experiencing excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. The settlement strengthens Axsome’s position by delaying generic competition for more than a decade, potentially preserving the medicine’s commercial value through at least 2040.
