Glenmark gets first-to-file status for 3 drugs in US

Glenmark Pharmaceuticals Ltd. | Pharmaceuticals & Drugs | Healthcare | BSE: 532296 | NSE: GLENMARK

03 Jul 2009 Evaluate

Glenmark Pharmaceuticals has received first-to-file status for three of its abbreviated new drug applications (ANDA) that have combined revenues of over $2 billion (about Rs 9,600 crore at current exchange rates) in the US. 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 recognises 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 Adminstration 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.

The latest first-to-file status was granted for Ezetimibe in April this year. Litigation for all three filings is in various stages, but if Glenmark wins, it will get a 180-day exclusive marketing period. Six month marketing exclusivity periods are much sought after, as it gives a company an edge over the competition in gaining market share before the space becomes highly competitive.

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