LONDON (dpa-AFX) - Axsome Therapeutics (AXSM) has entered into a settlement agreement with Hikma Pharmaceuticals USA, Inc. resolving patent litigation related to Axsomes product Sunosi or solriamfetol. 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. Axsome and Hikma will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
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 FDA seeking approval to market a generic equivalent of Sunosi in the United States.
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