Glenmark gets final US FDA nod for generic Cutivate lotion
Glenmark Generics Inc, the US arm of India’s Glenmark Pharmaceuticals, has received final approval from US Foods and Drugs Administration for its Abbreviated New Drug Application (ANDA) for Fluticasone Propionate skin lotion.
Glenmark’s Fluticasone Propionate is the generic version of US pharmaceutical company Nycomed’s Cutivate lotion.
Nycomed had in 2008 filed a patent infringement lawsuit in relation to Glenmark’s ANDA for fluticasone propionate lotion. Glenmark filed a paragraph IV certification that involves a patent challenge with the US drug regulator for its generic version.
Glenmark said if it wins the patent challenge it will be able to market drug exclusively for 180 days.
Nycomed’s Cutivate lotion had sales of about USD 48 million in 2010 in the US market.
Glenmark shares opened 2% higher on the announcement, and were trading up 1% at Rs 301 in early trade on National Stock Exchange.
May 04, 2011