Glenmark gets USFDA approval for cholesterol-lowering agent Ezetimibe

28 April 2009

Mumbai-based Glenmark Pharmaceuticals has achieved the distinction of becoming the first company to get tentative approval from the US Food and Drug Administratin (USFDA) to market Schering-Plough and MSP Singapore Company LLC's cholesterol-lowering drug, Zetia (Ezetimibe).

The company is expected to get 180 days marketing exclusivity for the drug when the patent expires.

According to sources Zetia had notched up $1.5 billion in sales in 2008 and the patent for the drug is to expire in 2014. The tentative approval has been granted for 10mg generic tablets of Ezetimibe.

Glenmark said the product launch would have to wait till final approval of its abbreviated new drug application (ANDA) by the FDA. A resolution of litigation currently with the US district court of New Jersey is also awaited.

According to the company's US subsidiary Glenmark Generics this was the first approval granted by the FDA for a generic version of the drug. It said the company has first-to-file status on Ezetimibe tablets giving it a potential 180-days of marketing exclusivity.

Glenmark would get an opportunity ahead of competitors to gain market share from the branded product Zetia. Product launch will take place once the final approval of it Abbreviated New Drug Appliation, or ANDA from the US FDA is received, according to the company.