Horizon Pharma (HZNP) Announces District Court Decision to Uphold PENNSAID 2% w/w Patent

May 15, 2017 7:09 AM EDT

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Horizon Pharma plc (NASDAQ: HZNP), 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 that the United States District Court for the District of New Jersey upheld the validity of Horizon Pharma’s patent 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%. The lawsuit claims infringement of Horizon's U.S. Patent No. 9,066,913 (‘913 patent) titled "Diclofenac Topical Formulation," which covers PENNSAID 2%. 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 18 Orange Book listed patents with terms that extend to 2030.



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