Axsome Therapeutics settles Sunosi patent litigation with Unichem

Axsome Therapeutics has entered into a settlement agreement with Unichem 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 Unichem 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. The settlement agreement permits Unichem to begin selling its generic version of Sunosi on June 30, 2042, or earlier under certain circumstances. The June 30, 2042 date is also subject to potential extension for pediatric exclusivity. As required by law, Axsome and Unichem 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 other parties remains pending in the U.S. District Court for the District of New Jersey.