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.

Glenmark filed an ANDA with the USFDA for marketing a generic version of Ezetimibe on 25October 2006. The ANDA included a Paragraph IV certification referring to patents listed by Schering. Following the filing Glenmark was sued by Schering in the US for challenging the patent of this drug.

Glenmark, through its US subsidiary, Glenmark Generics markets around 40 generic drugs in the US and according to sources has over 40 ANDAs filed wit the USFDA. Many of these are believed to have first-to-file status.

Glenmark Generics Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (Glenmark) and aims to be a global integrated Generic and API leader. GGL has an established presence in North America, EU and Argentina and maintains marketing front-ends in these countries.

Mumbai-headquartered Glenmark Pharmaceuticals Ltd is a research-driven, integrated pharmaceutical company and is among the leaders among Indian pharmaceutical companies in the discovery of new molecules. It is focused in the areas of inflammation and metabolic disorders.