Glenmark gets tentative USFDA approval for Zetia
Glenmark gets tentative USFDA approval for generic version on Zetia. It is Schering Plough’s $ 1.5 billion Cholestrol lower drug. Zetia is an anticholestrol drug sold by Schering Ploughand MSP Singapore. It expects 180 days of marketing exclusivity for its version of the drug. Global market size for the drug is $ 1.8 billion.
The PARA IV litigation with the innovator is still on in the courts. Glenmark filed for ANDA in Oct 2006 and the court has to pass the order within 30 months of the filing which means it could be coming anytime soon. Having said that, only if Glenmark wins the case it will get to sell the drug. If it loses the case, this tentative approval from FDA is of no consequence. So, company is not giving any expectation as such.
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