Axsome Therapeutics Reaches Settlement With Teva On AUVELITY Patent Litigation

Axsome Therapeutics

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(RTTNews) - Biopharmaceutical company Axsome Therapeutics, Inc. (AXSM) announced that it has entered into a settlement agreement with Teva Pharmaceuticals, Inc. resolving all patent litigation related to Axsomes AUVELITY (dextromethorphan HBr bupropion HCl) product.

The litigation resulted from submission by Teva of an Abbreviated New Drug Application to the U.S. Food and Drug administration (FDA) seeking approval to market a generic version of AUVELITY in the U.S. prior to the expiration of applicable Axsome patents.

Under the terms of the settlement agreement, Axsome will grant Teva a license to sell its generic version of AUVELITY beginning on or after March 31, 2039, if pediatric exclusivity is granted for AUVELITY, or on or after September 30, 2038, if no pediatric exclusivity is granted, subject to FDA approval and conditions and exceptions customary for agreements of this type.

In accordance with the agreement, the parties will terminate all ongoing litigation between Axsome and Teva regarding AUVELITY patents pending in the U.S. District Court for the District of New Jersey.

The settlement agreement resolves all outstanding patent litigation relating to AUVELITY.

As required by law, Axsome and Teva will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.