Glenmark Pharmaceuticals today announced the settlement of litigation with Daiichi Sankyo and Genzyme Corporation regarding Glenmark's Abbreviated New Drug Application (ANDA) tiled with the US Food and Drug Administration (FDA) for Colesevelam Hydrochloride, a drug used in treatment of type-2 diabetes.
In November last year, Daiichi Sankyo and Genzyme filed a patent infringement suit in the US District Court for the District of Delaware seeking to prevent Glenmark from commercialising its ANDA prior to expiration of the Orange Book patents.
With this agreement between the parties, Glenmark has received a license from Daiichi Sankyo and Genzyme that will permit Glenmark to launch its generic Colesevelam Hydrochloride products on April 02, 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 indicated for the treatment of primary hyperlipidemia and type 2 diabetes mellitus.
As per IMS Health data, a pharma consultancy, total sales for the oral suspension were around $51 million and $327 million for the tablet for the twelve months ended December 31 last year.
Glenmark Pharma's stocks were trading at Rs 318 on Bombay Stock Exchange at 1145 hours, up 0.51% from previous close.