Diclofenac – USA

Diclofenac – USA

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.          
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