Axsome Therapeutics, Inc. (NASDAQ:AXSM) (Axsome), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it has resolved all patent litigation related to Axsome's product SUNOSI (solriamfetol). The litigations resulted from submission of Abbreviated New Drug Applications to the U.S. Food and Drug Administration by companies seeking approval to market a generic version of SUNOSI in the United States.

Axsome resolved all outstanding SUNOSI patent litigation upon entering into a settlement agreement with the only remaining first-to-file generic applicant with pending patent litigation related to Axsome's product SUNOSI. As part of the resolution of these lawsuits, Axsome will grant five companies the right to sell generic versions 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 conditions and exceptions customary for agreements of this type. No other patent litigation relating to SUNOSI remains pending.

As required by law, Axsome will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.