Axsome Therapeutics has reached a settlement agreement with Hetero Labs Ltd. to resolve patent litigation concerning Axsome's product SUNOSI® (solriamfetol). The legal dispute arose after Hetero submitted an Abbreviated New Drug Application to the U.S. FDA to market a generic version of SUNOSI. According to the settlement terms, Hetero is permitted to sell its generic version starting on or after September 1, 2040, if pediatric exclusivity is granted, or on or after March 1, 2040, if not, contingent upon FDA approval. The agreement will be reviewed by the U.S. Federal Trade Commission and the U.S. Department of Justice. Other similar patent litigations remain ongoing.
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