Axsome received Paragraph IV certification notice on Auvelity ANDA from Teva

In a regulatory filing earlier, Axsome Therapeutics (AXSM) disclosed that on February 10, the company received a Paragraph IV Certification Notice Letter from Teva Pharmaceuticals (TEVA), providing notification to the company that Teva has submitted an Abbreviated New Drug Application, or "ANDA," to the U.S. Food and Drug Administration seeking approval to manufacture, use, or sell a generic version of Auvelity, or dextromethorphan HBr-bupropion HCl. "In the Notice Letter, Teva alleges that four of the patents listed in the FDA Orange Book for Auvelity, U.S. Patent Numbers 10,780,064; 10,925,842; 10,940,124; and 10,966,942, each of which expires in 2040, are invalid, unenforceable, or will not be infringed by Teva’s manufacture, use, or sale of the generic product described in its ANDA submission. The Paragraph IV Certification does not challenge any of the remaining Orange Book listed patents for Auvelity which have expirations out to 2034," Axsome stated in the filing.