It believes the 180-day exclusivity for its Hydrocortisone Butyrate cream has been violated
Glenmark Generics, on Thursday, said that its U.S. subsidiary had filed a lawsuit in the Court of Chancery of the State of Delaware, U.S., to enforce Glenmark’s royalty-bearing licence agreement.
A statement from Glenmark said that it had an agreement with Triax Pharmaceuticals, Astellas Pharma Europe BV and Astellas Pharma International BV under which Glenmark is entitled to 180 days of exclusivity with respect to its Hydrocortisone Butyrate cream, as it is the first generic company to file an abbreviated new drug application (ANDA) for the product.
Glenmark Generics Inc. USA, which is a subsidiary of Glenmark Generics, has filed a lawsuit in the state of Delaware against Astellas Pharma Europe BV, Astellas International, Triax Pharmaceuticals LLC, Precision Dermatology Inc, Onset Dermatologics LLC and Metacon Labs.
The company recently announced that the United States Food and Drug Administration (US FDA) had approved its ANDA for Hydrocortisone Butyrate Cream USP (0.1 per cent), a generic version of Locoid Lipocream.
Glenmark said it filed the lawsuit earlier this week after learning that Metacon Labs had launched a generic equivalent of Locoid Lipocream. “Glenmark is seeking, among other things, a temporary restraining order enjoining the sale, manufacturing or marketing of generic equivalents of Locoid Lipocream by any of the defendants in violation of Glenmark’s exclusivity period,” the statement said.
Hydrocortisone Butyrate cream is used for relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults and the treatment of mild to moderate atopic dermatitis in patients of 3 months to 18 years of age, Glenmark said, adding that according to IMS Health sales data for the 12 month period ending June 2013, Hydrocortisone Butyrate Cream had sales of about $34 million.