Axsome Therapeutics settles Sunosi patent litigation with Hikma

Axsome Therapeutics (AXSM) announced that it has entered into a settlement agreement with Hikma Pharmaceuticals (HKMPF), 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 Hikma of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic equivalent of Sunosi in the United States. Under the terms of the settlement agreement, Axsome will grant Hikma 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.