Dr. Reddy's files patent infringement against Perrigo UK & others

Dr Reddy’s Laboratories Limited today said subsidiary Promius Pharma LLC, has filed a patent infringement lawsuit in a US court against Perrigo UK Finco Limited Partnership, Perrigo Israel Pharmaceuticals Ltd. and Taro Pharmaceuticals, Inc over its topical spray Sernivo. In a filing with the bourses,it said the case was filed in the United States District Court for Eastern District of Texas against the three companies “in response to two paragraph-IV notice letters received for its twice daily topical spray Sernivo (betamethasone dipropionate, 0.05%) product.” A notice under Paragrap IV will be issued to a patent holder when a generic company wants to make a similar drug. Promius said it anticipates this lawsuit will trigger a 30 month stay of Food and Drug Administration approval of Perrigo’s and Taro’s Abbreviated New Drug Application (ANDA).

Sernivo spray is protected by six Orange Book patents that expire in 2030. The publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as Orange Book) identifies drug products approved on the basis of safety and effectiveness by FDA under the Federal Food,Drug, and Cosmetic Act (the Act) and related patent and exclusivity information. Promius will continue to vigorously defend its Intellectual Property Rights against infringement wherever they are challenged, the filing said.

Source: The Hindu

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