(RTTNews) - Axsome Therapeutics, Inc. (AXSM), a biopharmaceutical company focused on central nervous system (CNS) disorders, announced it has reached a settlement resolving all patent litigation related to its product SUNOSI (solriamfetol).
The litigation stemmed from Abbreviated New Drug Applications filed with the U.S. FDA by companies seeking to market generic versions of SUNOSI in the U.S. Axsome has now entered into a settlement agreement with the remaining first-to-file generic applicant, effectively closing all outstanding cases.
Under the terms of the settlement, Axsomew will grant five companies the right to sell generic versions of SUNOSI beginning on or after September 1, 2040, if pediatric exclusivity is granted, or on or after March 1, 2040, if not, subject to FDA approval and customary conditions. No other patent litigation concerning SUNOSI remains pending. As required, Axsome will submit the settlement agreement to the U.S. Federal Trade Commission and the Department of Justice for review.
SUNOSI is approved in the U.S. for excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea. Axsome's broader neuroscience portfolio also includes FDA-approved treatments for major depressive disorder, agitation linked to Alzheimer's disease, and migraine, alongside multiple investigational candidates.
This settlement provides long-term clarity for SUNOSI's market exclusivity while allowing Axsome to continue focusing on expanding its CNS pipeline and advancing therapies for conditions that affect millions of patients.
AXSM has traded between $96.09 and $238.56 over the past year. The stock closed Wednesday's trading at $233.49, up 5.10%.
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