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

Meanwhile, litigation for all three filings are in various stages. The latest first-to-file status was granted for Ezetimibe in April this year. Zetia (Ezetimibe) is manufactured by Schering-Plough and had annual sales of $1.5 billion in the US in 2008.

Tarka (Trandolapril + Verapamil) is manufactured by Abbott and Sanofi Aventis, for which the opportunity is $72 million in sales, while Cutivate (Fluticasone lotion) is manufactured by Nycomed, and has a market of $37 million.

When contacted, a Glenmark spokesperson confirmed the development but declined to comment on the issue as the matter was subjudice.

Glenmark is also looking to tap the over-$300 million psoriasis relieving drug market but has been taken to court in the US by Medicis Pharmaceuticals, a specialty pharma company, over its attempt to manufacture generic versions of Medicis’ drug Vanos (fluocinonide cream). In a case filed in the US District Court of New Jersey in June, Medicis claims that Glenmark violated two of its patents related to Vanos, which have patent protection till 2021 and 2023.

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