Glenmark confirms patent challenge for Bendamustine Hydrochloride

31 Dec 2013 Evaluate

Glenmark Pharmaceuticals and Glenmark Generics Inc., USA (Glenmark) has confirmed that Cephalon Inc. has filed a patent infringement suit on December 26, 2013 in the US District Court for the District of Delaware seeking to prevent Glenmark from commercializing its Abbreviated New Drug Application (ANDA) Bendamustine Hydrochloride product, their generic version of Treanda, prior to expiration of the Orange Book patents. This lawsuit was filed under the provisions of the Hatch-Waxman Act.

Bendamustine is indicated for the treatment of patients with Chronic Lymphocytic Leukemia. This ANDA has been filed from Glenmark’s Argentina lyophilized injectable facility. For the twelve-month period ending September 2013, Treanda achieved sales of $659 million according to IMS Health.

Glenmark Generics (GGL) is a subsidiary of Glenmark Pharmaceuticals (Glenmark) and aims to be a global integrated Generic and API leader. GGL, has an established presence in North America and developing an EU presence, which primarily sells its FDF products in the United States (US) and the European Union (EU), as well as its oncology FDF products in South America. The Company supplies APIs to customers in approximately 80 countries, including the US, various countries in the EU, South America and India.

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