Avanir Pharmaceuticals Files Lawsuits Against Par and Actavis for Infringement of NUEDEXTA Patents

Avanir Pharmaceuticals, Inc. AVNR today announced that it has filed lawsuits in the U.S. District Court for the District of Delaware against Par Pharmaceutical, Inc. PRX and Par Pharmaceutical Companies, Inc and Actavis South Atlantic LLC and Actavis, Inc.. The lawsuits were filed in response to Abbreviated New Drug Applications filed by Par and Actavis. In their applications, Par and Actavis seek to market and sell generic versions of the currently approved dose of NUEDEXTA® prior to the expiration of U.S. patents 7,659,282 and RE38,115 (which are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations). Avanir filed the lawsuits on the basis that Par's and Actavis' proposed generic products infringe certain patents held by Avanir. In accordance with the Hatch-Waxman Act, as a result of having filed lawsuits within 45 days of the Paragraph IV certification notices, FDA approval of the ANDAs will be stayed until the earlier of (i) 30 months from the Company's receipt of the notices or (ii) a District Court decision finding that the identified patents are invalid, unenforceable or not infringed.