Glenmark Pharmaceuticals has received first-to-file status for three of its abbreviated new drug applications (ANDA) that have combined revenue of over USD 2 billion in the US, reports Economic Times.

The company has received first-to-file status for Zetia (generic name Ezetimibe), Tarka (Trandolapril + Verapamil) and Cutivate (Fluticasone lotion).

First-to-file status typically recognizes a generic company as being the first to file a para IV application challenging a particular patent and seeking to manufacture generic versions of a drug which, at present, does not have generic competition.

With the first-to-file status, comes a 180-day marketing exclusivity (from the date of approval of the ANDA), during which the Food and Drug Administration may not approve another ANDA for such generic product.

During this period, the first-to-file generic company can reap huge benefits on the sale of the generic drug, which is typically sold at a price ranging from 70-80% of the brand product price.

This would be before other generic equivalents enter the market following the expiration of the 180-day exclusivity period.

Shares of the company closed up Rs 9.3, or 4.44%, at Rs 218.90. The total volume of shares traded at the BSE was 547,909 (Thursday).