Axsome Therapeutics, Inc. (NASDAQ: AXSM) stock price surged 23.46% on the charts to $130.58 on the announcement of a settlement of a patent dispute with Teva Pharmaceuticals. All pending litigation pertaining to its AUVELITY (dextromethorphan HBr – bupropion HCl) product is resolved by the agreement.
Settlement of the Patent Conflict
The case started when Teva filed an Abbreviated New Drug Application (ANDA) with the FDA in the United States to get permission to produce and sell a generic version of AUVELITY before Axsome’s patent expired. By offering a final resolution, this settlement guarantees AXSM’s continued exclusivity over its product.
Conditions of the Settlement Contract
Teva has been licensed by Axsome to commercialize its generic version of AUVELITY beginning on March 31, 2039, or later if pediatric exclusivity is approved. Without this exclusivity, Teva may start selling products on or after September 30, 2038. The deal has usual terms and exclusions for settlements of this kind and is still pending FDA clearance.
All pending lawsuit between Axsome and Teva in the U.S. District Court for the District of New Jersey will be dropped as a result of this settlement. The settlement strengthens AXSM’s intellectual property rights and resolves the legal ambiguities concerning AUVELITY’s patent protection.
Dedication to Neuroscience Innovation
With AUVELITY as evidence of its invention in the sector, Axsome is still committed to developing medicines for illnesses of the central nervous system. AXSM’s dedication to provide innovative treatments for challenging-to-treat illnesses is further reinforced by the successful defense of its patent portfolio.
Business Update and Financial Report
Alongside the court settlement, Axsome is also in plans of releasing its financial results for the fourth quarter and full year of 2024 on next Tuesday. To explain the findings and give a business forecast, the management of the company will have a conference call that morning. Stakeholders and investors will be keenly monitoring AXSM’s performance in the market and any new developments.