Axsome Therapeutics, Inc. (NASDAQ: AXSM) has announced a settlement agreement with Hetero Labs Ltd. and its affiliates, resolving patent litigation related to its product Sunosi® (solriamfetol). Under the terms of the settlement, Axsome will grant Hetero a license to sell its generic version of Sunosi beginning on or after September 1, 2040, if pediatric exclusivity is granted for Sunosi, or on or after March 1, 2040, if no pediatric exclusivity is granted, subject to FDA approval and customary conditions and exceptions.
This settlement comes as a result of pending litigation in the United States District Court for the District of New Jersey, stemming from Hetero's submission of an abbreviated new drug application seeking approval to market a generic version of Sunosi in the United States.
Axsome has also noted that similar patent litigation brought against other parties related to Sunosi remains pending in the U.S. District Court for the District of New Jersey.
Axsome Therapeutics is a biopharmaceutical company focused on leading advancements in the treatment of central nervous system (CNS) conditions. The company's portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine. Additionally, Axsome has multiple late-stage development programs addressing various serious neurological and psychiatric conditions impacting over 150 million people in the United States. Today the company's shares have moved -0.94% to a price of $104.085. If you want to know more, read the company's complete 8-K report here.
