MUMBAI: Glenmark Pharmaceuticals has got tentative approval from the USFDA for the generic version of Schering Plough and MSP Singapore Company LLC's hypercholesterolemia treatment Zetia (ezetimibe). The company's US subsidiary Glenmark Generics, said this is the first tentative approval granted by the FDA for a generic version of the drug. Glenmark said it has first-to-file status on Ezetimibe tablets, giving it a potential of 180-days of marketing exclusivity.
Glenmark would have the earliest opportunity among any competitors to gain market share from the branded product Zetia which achieved sales of $1.5 billion in 2008. Product launch is dependent upon receipt of final approval of its Abbreviated New Drug Application, or ANDA from the US FDA and resolution of litigation currently pending in the US district court of New Jersey, the company said in a release.
Glenmark filed an ANDA with the USFDA seeking regulatory approval to market a generic version of Ezetimibe on October 25, 2006. Glenmark's ANDA included a Paragraph IV certification with respect to patents listed by Schering The company will also be vertically integrated by manufacturing the active pharmaceutical ingredient for its Ezetimibe tablets.
Glenmark's current portfolio consists of around 40 generic products authorized for distribution in the US market. The company currently has over 40 ANDAs filed with the USFDA pending approval. | |
No comments:
Post a Comment