Glenmark Pharmaceuticals Limited, Glenmark Generics Limited and Glenmark Generics Inc., USA (Glenmark) announce the settlement of litigation with Daiichi Sankyo, Inc. and Genzyme Corporation (Daiichi Sankyo and Genzyme) regarding Glenmarkâs Abbreviated New Drug Application (ANDA) filed with the US Food and Drug Administration for colesevelam hydrochloride.
Daiichi Sankyo and Genyzme 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 expiration of the Orange Book patents. This announcement confirms that parties have reached a settlement agreement and Glenmark has received a license from Daiichi Sankyo and Genzyme that will permit Glenmark to launch its generic colesevelam hydrochloride products on April 2, 2015, or earlier under certain circumstances.
Daiichi Sankyo currently markets colesevelam hydrochloride as a powder for oral suspension as well as in tablet form as Welchol 1 indicated for the treatment of primary hyperlipidemia and type 2 diabetes mellitus. Total sales as reported by IMS Health for the 12 month period ending December 2010 were approximately US$ 51 million for the oral suspension and US$ 327 million for the tablet.
Glenmark Generics Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (Glenmark) and aims to be a global integrated Generic and API leader.