Amifampridine phosphate

Teva will keep its generic version of Axsome's depression drug Auvelity off the market until at least 2038 after the companies reached an agreement to resolve a patent infringement lawsuit. Axsome Therapeutics has resolved the patent infringement lawsuit that it filed against Teva Pharmaceutical Industries after the generics powerhouse sought FDA approval for a copycat to Axsome's major depressive disorder (MDD) drug Auvelity.With the settlement, Teva will not market the Auvelity generic until September 30, 2038, Axsome said in a Monday press release. Entrance of the generic will be delayed by an additional six months, until March 31, 2039, if Axsome gains an FDA pediatric exclusivity extension for its treatment.With the agreement, Axsome’s share price increased by more than 20% Monday morning. Mizuho analyst Graig Suvannavejh, Ph.D. called the settlement “a significant positive,” for the 13-year-old CNS specialist.“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,” Axsome CEO Herriot Tabuteau, M.D., said in a statement. The FDA approved Auvelity in August of 2022 and just six months later, according to a securities filing, Teva notified Axsome that it was applying for FDA approval of its copycat. A month later, Axsome responded with an infringement lawsuit in federal court in New Jersey.Sales of Auvelity increased significantly in each quarter of last year, from $53 million in the first quarter to $93 million in the fourth. Total sales in 2024 were $291 million.At the time of its approval, Auvelity was the first oral MDD drug to enter the market with a new mechanism of action in more than 60 years. While the response time for typical antidepressants is usually six to eight weeks or longer, Auvelity’s benefits can be seen within a week. Less than two weeks ago, Axsome gained a hard-earned FDA approval for another of its rapid-acting drugs, Symbravo, for the treatment of acute migraine episodes. The company also posted positive phase 3 data recently for its narcolepsy drug AXS-12, which it acquired from Pfizer.The settlement is the second in as many months for Teva, which resolved patent litigation with Catalyst, agreeing to delay its market entrance of a generic version of the rare disease drug Firdapse until 2035.