On May 15, 2017 United States District Court for the District of New Jersey upheld the validity of Horizon Pharma’s patent, US 9,066,913 (expiring on Oct 17, 2027) covering PENNSAID® (diclofenac sodium topical solution) 2% w/w, which Actavis Laboratories UT, Inc. (Actavis) has admitted that its proposed generic diclofenac sodium topical solution product would infringe.
On July 6, 2015, Horizon filed a patent infringement lawsuit in District Court against Actavis related to Abbreviated New Drug Applications filed with the U.S. Food and Drug Administration to market a generic version of PENNSAID 2%. Bench trial was completed in Mar 2017. The District Court’s decision was made based on the validity of Horizon Pharma’s ‘913 patent for PENNSAID 2% and the Court’s judgment will prevent Actavis from launching a generic version of PENNSAID 2% in the United States.
PENNSAID 2% has 19 Orange Book listed patents with terms that extend to 2030. Paddock Labs (Perrigo), Taro, Lupin, Amneal, IGI Labs (Teligent) are other Para IV filers.