Axsome Therapeutics has resolved patent litigation related to Teva’s generic version of its top-selling tablet, Auvelity.
According to Axsome, the litigation is a result of Teva submitting an ANDA to the U.S. FDA in 2023, seeking approval to market a generic version of Auvelity (dextromethorphan HBr – bupropion HCl) in the U.S. prior to the expiration of applicable Axsome patents.
Axsome's extended-release oral tablet was approved under the brand name Auvelity for the treatment of major depressive disorder back in 2022. The drug is Axsome’s top-seller, bringing in $291.4 million in net sales last year.
Now, 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.
Unrelated to the suit, Axsome is also looking to get a version of the drug approved in Alzheimer’s disease agitation and plans to submit an NDA to the FDA in the second half of 2025.