Glenmark Pharmaceuticals announced that it has received tentative approval from the U.S. Food and Drug Administration (FDA) to sell the generic version of Schering Plough and MSP Singapore Company LLC’s hypercholesterolemia treatment Zetia (ezetimibe) in the United States.

Glenmark, which has got sanction for 10-milligram tablets of the drug, is likely to get 180 days marketing exclusivity for the drug upon patent expiry.

Zetia recorded sales of $1.5 billion during the last year (2008), the drug maker said in a statement.

In an announcement, the company's US arm Glenmark Generics stated that this is the first tentative approval given by the FDA for a generic version of the drug.

However, Glenmark said that the launching of the product is contingent upon receipt of final nod of its Abbreviated New Drug Application, or ANDA from the US FDA and resolution of legal action presently pending in the US district court of New Jersey, the company said in a release.

It should be noted that, Glenmark had registered its Abbreviated New Drug Application with FDA in quest of regulatory sanction to sell a generic version of Ezetimibe on October 25, 2006.

Glenmark's ANDA included a Paragraph IV certification relating to patents named by Schering. The company will also be vertically integrated by making the active pharmaceutical component for its Ezetimibe tabs.

Glenmark's existing portfolio comprises around 40 generic products authorized for distribution in the US market.

At present, the company has more than 40 ANDA's filed with the U. S. FDA pending approval.