The US-based Cephalon Inc has filed a patent infringement suit against Glenmark over Indian company’s plans to sell generic version of leukaemia treatment drug Treanda in the US. “Glenmark Pharmaceuticals Limited and Glenmark Generics Inc, USA confirms Cephalon Inc has filed a patent infringement suit on 26 Dec 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,” said the company in a BSE filing.
Bendamustine is indicated for the treatment of patients with chronic lymphocytic leukemia. This ANDA has been filed from Glenmark's Argentina lyophilised injectable facility. For the twelve-month period ending September 2013, Treanda achieved sales of $ 659 million according to IMS Health.
Bendamustine is indicated for the treatment of patients with chronic lymphocytic leukemia. This ANDA has been filed from Glenmark's Argentina lyophilised injectable facility. For the twelve-month period ending September 2013, Treanda achieved sales of $ 659 million according to IMS Health.