Glenmark Pharmaceuticals settles the litigation for Colosevelam hydrochloride

04 Jul 2011 Evaluate

Glenmark Pharmaceuticals’, Glenmark Generics and Glenmark  Generics Inc, USA  have settled the litigation with Daiichi Sankyo Inc and Genzyme Corporation regarding Glenmark’ s Abbreviated New Drug Application (ANDA) filed with the US Food and Drug Administration (USFDA) for Colosevelam hydrochloride.

Daiichi Sankyo and Genzyme Corporation filed a patent infringement suit in November 2010 in the US District Court for the District of Delaware seeking to prevent Glenmark from commercializing its ANDA prior to the expiration of the Orange Book patents.

Thus, with the settlement agreement Glenmark has received a license from Daiichi Sankyo and Genzyme, thereby permitting Glenmark to launch its Generic Colosevelam hydrochloride products on April 2, 2015, or earlier under certain circumstances.

Daiichi Sankyo currently markets Colosevelam hydrochloride as a powder for oral suspension as well as in tablet form as Welchol indicated for the treatment of primary hyperlipidemia and type 2 diabetes mellitus. The total sales are reported by IMS Health for the 12 months period ending December 2010 approximately 2010 were approximately $51 million for the oral suspension and $327 million for the tablet.

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