Glenmark Pharmaceuticals and Glenmark Generics, USA (Glenmark) has confirmed that Cephalon 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 commercialising its Abbreviated New Drug Application (ANDA) Bendamustine Hydrochloride product, their generic version of Treanda, prior to expiration of the Orange Book patents.
A complaint against Glenmark has been filed on US patent 8,445,524. This lawsuit was filed under the provisions of the Hatch-Waxman Act. Bendamustine is indicated for the treatment of patients with chronic lymphocytic leukaemia.
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.
EP News Bureau – Mumbai
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