Biopharmaceutical company Axsome Therapeutics Inc (NASDAQ:AXSM) announced on Monday that it has reached a settlement agreement with Israel-based pharmaceutical company Teva Pharmaceutical Industries Ltd (NYSE:TEVA) (TASE:TEVA) resolving all patent litigation related to AUVELITY (dextromethorphan HBr – bupropion HCl).
The dispute arose after Teva filed an Abbreviated New Drug Application seeking US Food and Drug Administration (FDA) approval to market a generic version of AUVELITY before Axsome's patents expired.
Under the agreement, Axsome will grant Teva a licence to sell its generic version starting on or after 31 March 2039, if paediatric exclusivity is granted for AUVELITY, or 30 September 2038, if not, subject to FDA approval and other customary conditions and exceptions. The parties also agreed to terminate all ongoing litigation in the US District Court for the District of New Jersey.
This agreement resolves all outstanding patent disputes relating to AUVELITY.
Axsome and Teva will submit the settlement for review by the US Federal Trade Commission and the US Department of Justice, as required by law.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval