Glenmark Generics Inc files law suit to enforce licence pact

NEW DELHI: Glenmark Pharmaceuticals today said it's US subsidiary has filed a lawsuit in the Court of Chancery of the State of Delaware to enforce it's exclusive royalty-bearing licence agreement.

The agreement is with Triax Pharmaceuticals, Astellas Pharma Europe BV and Astellas Pharma International BV.

Under the royalty-bearing licence agreement, Glenmark is entitled to 180 days of exclusivity for 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, the subsidiary of Glenmark Generics Ltd has filed a lawsuit in the Court of Chancery of the State of Delaware against Astellas Pharma Europe B V, Astellas International, Triax Pharmaceuticals LLC, Precision Dermatology Inc, Onset Dermatologics LLC and Metacon Labs, Glenmark Pharmaceuticals said in a statement.

"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 company said.

The company filed this lawsuit earlier this week after learning that Metacon Labs has launched a generic equivalent of Locoid Lipocream, it added.

Glenmark had recently announced that the United States Food and Drug Administration (USFDA) approved its ANDA for Hydrocortisone Butyrate Cream USP (0.1 per cent), a generic version of Locoid Lipocream.

According to IMS Health sales data for the 12 month period ending June 2013, Hydrocortisone Butyrate Cream garnered annual sales of nearly USD 34 million, it added.

"The company's product is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses in adults and the treatment of mild to moderate atopic dermatitis in patients 3 months to 18 years of age," Glenmark Pharmaceuticals said.