Horizon Pharma plc Files Patent Infringement Lawsuits Against Five Companies for Filing Abbreviated New Drug Applications for PENNSAID 2%

Horizon Pharma plc

, a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, today announced it has filed patent infringement lawsuits in the United States District Court for the District of New Jersey against Actavis Laboratories UT, Inc., Actavis, Inc., and Allergan plc (collectively "Actavis"), Amneal Pharmaceuticals, LLC ("Amneal"), IGI Laboratories, Inc. ("IGI"), Lupin Ltd. and Lupin Pharmaceuticals, Inc. ("Lupin"), and Taro Pharmaceuticals USA, Inc. and Taro Pharmaceutical Industries, Ltd. (collectively "Taro") related to Abbreviated New Drug Applications filed with the U.S. Food and Drug Administration to market a generic version of PENNSAID® (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%). The lawsuits claim infringement of Horizon's newly issued U.S. Patent No. 9,066,913 titled "Diclofenac Topical Formulation," which covers PENNSAID 2%. These lawsuits are the second patent litigations filed against these defendants relating to PENNSAID 2%.