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.
Independent Pharmacy Cooperative signs cooperation agreement with Legacy Pharmacy Group
ILIKOS Consulting partners with Jordan Center for Pharmaceutical Research
Axsome Therapeutics settles patent litigation with Teva over AUVELITY
Breckenridge Pharmaceutical's Everolimus Tablets for Oral Suspension receive US FDA approval
Newbury Pharmaceuticals secures generic approval for pomalidomide in Denmark
Newbury Pharmaceuticals secures generic approval for Bosutinib in Norway
Guangzhou Fermion Technology partners with Simcere Pharmaceutical
Veeda Group rebrands as 'Veeda Lifesciences'
ANI Pharmaceuticals launches generic Motegrity tablets
Hikma Pharmaceuticals USA receives FDA approval for diabetes drug
Full Circles Therapeutics advances non-viral gene editing innovation
Induction Healthcare secures national video solution contract in Ireland
Safecor Health acquires Viatris' US unit-dose packaging business
LOG Pharma Primary Packaging opens new clean room
American Regent launches 30 mL Epinephrine Injection, USP in US