Axsome Therapeutics (AXSM) Announces Settlement Agreement Resolving AUVELITY Patent Litigation

Axsome Therapeutics, Inc. (NASDAQ: AXSM) (Axsome), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it has entered into a settlement agreement with Teva Pharmaceuticals, Inc. (Teva) resolving all patent litigation related to Axsome’s 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 United States 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.

“Axsome is proud of its commitment to innovating treatments aimed at improving the lives of the millions of patients living with central nervous system disorders. The resolution of this patent litigation underscores the value of that innovation as it relates to AUVELITY, and more broadly reflects the strength of Axsome’s intellectual property portfolio,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics. “With our industry-leading neuroscience pipeline addressing difficult-to-treat conditions, we look forward to continuing to serve our patient communities through innovation and delivery of differentiated new medicines.”

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.

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