Mumbai-based Glenmark Pharmaceuticals has become the first company to get tentative approval from the US Food and Drug Administration (USFDA) to sell the generic version of Schering-Plough and MSP Singapore Company LLC’s cholesterol-lowering drug, Zetia (Ezetimibe).
Glenmark is expected to get 180 days marketing exclusivity for the drug upon patent expiry.
Sources said Zetia had sales of $1.5 billion in 2008 and the main patent for this drug would expire in 2014. The tentative approval has been granted for 10 mg generic tablets of Ezetimibe.
Glenmark said the product launch was dependent on final approval of its abbreviated new drug application (ANDA) by the FDA and the resolution of litigation currently pending in the US district court of New Jersey.
Under US rules for selling generic drugs, the first company to challenge the patent of the innovator drug, through a Paragraph IV certified marketing application, gets 180 days marketing exclusivity on the expiry of the patent. The innovator has to sue the generic company within 45 days of the Para IV challenge to get a 30-month stay on final marketing approval.
Glenmark filed an ANDA with the FDA seeking regulatory approval to market the generic version of Ezetimibe on October 25, 2006. Following this, Schering-Plough sued Glenmark in the US for challenging the patent of this drug.
Glenmark, through its US subsidiary, Glenmark Generics, currently markets around 40 generic drugs in the US. Glenmark sources said it currently had over 40 ANDAs filed with the US FDA pending approval and many of these were believed to have first-to-file status.
Its share price rose 0.6 per cent to Rs 198.15 at the close of trading on the Bombay Stock Exchange.
