Axsome Therapeutics settles SUNOSI patent litigation with Alkem

Axsome Therapeutics (AXSM) entered into a settlement agreement with Alkem Laboratories resolving patent litigation related to Axsome’s product SUNOSI. The litigation, which is pending in the United States District Court for the District of New Jersey, resulted from submission by Alkem of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic version of SUNOSI in the United States. Under the terms of the settlement agreement, Axsome will grant Alkem 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 conditions and exceptions customary for agreements of this type. As required by law, Axsome and Alkem will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. Similar patent litigation brought by Axsome against another party related to SUNOSI remains pending in the U.S. District Court for the District of New Jersey.