Axsome Therapeutics enters settlement agreement with Hetero Labs

Axsome Therapeutics (AXSM) announced that it has entered into a settlement agreement with Hetero Labs Ltd. and certain of its affiliates 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 Hetero 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 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 conditions and exceptions customary for agreements of this type.