Glenmark Generics Ltd's US subsidiary (GGI) announced that the US Food and Drug Administration (US DA) has granted tentative approval for the generic version of Schering Plough and MSP Singapore Company LLC's hypercholesterolemia treatment Zetia (ezetimibe).

The tentative approval granted by the US-FDA is for the 10 mg tablets of ezetimibe and constitutes the first tentative approval granted by the FDA for a generic version of the drug. Glenmark believes that it has first-to-file status on ezetimibe tablets, thereby providing a potential of 180-days of marketing exclusivity.

Glenmark would have the earliest opportunity among any competitors to gain market share from the branded product Zetia which achieved sales of USD 1.5 billion in 2008. Product launch is dependent upon receipt of final approval of its ANDA from the US FDA and resolution of litigation currently pending in the US district court of New Jersey.

The company will be vertically integrated by manufacturing the active pharmaceutical ingredient for its ezetimibe tablets.

Glenmark filed an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration (FDA) seeking regulatory approval to market a generic version of ezetimibe on October 25, 2006. Glenmark's ANDA included a Paragraph IV certification with respect to patents listed by Schering in the FDA "Orange Book."

Glenmark's current portfolio consists of around 40 generic products authorized for distribution in the US market. The company currently has over 40 ANDA's filed with the US FDA pending approval. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.