Impax Laboratories Confirms Patent Challenge Relating to Generic NUEDEXTA® 20 mg/10 mg

Impax Laboratories, Inc. IPXL today confirms that it has initiated a challenge of the patents listed in connection with Nuedexta® (dextromethorphan hydrobromide and quinidine sulfate 20 mg / 10 mg) capsules. Impax filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of Nuedexta® with the U.S. Food & Drug Administration (FDA). Following receipt of the notice from FDA that Impax's ANDA had been accepted for filing, Impax notified the New Drug Application holder and patent owners of its paragraph IV certification. On August 29, 2011, Avanir Pharmaceuticals, Inc., Avanir Holding Company and Center for Neurologic Study filed suit for patent infringement against Impax Laboratories, Inc. in the District of Delaware. This action formally initiates the patent challenge process under the Hatch-Waxman Act. Once the ANDA