Saturday 30 May, 2009

Montelukast (Singulair) 10 mg tablets: Teva got tentative approval

Generic pharma giant Teva Pharma has got tentative approval to market Montelukast 10 mg tablets. Teva got tentative approval on May 21, 2009. Teva's generic version is bioequivalent to innovator Merck's Montelukast (Singulair) 10 mg tablets. Teva can market this product after the expiry of product patent (in 2012).
Further, innovator and Teva are in litigation on this product. Also, USPTO will re-examine innovator Merck's Orange Book listed patent. In case of favorable decision from USPTO or Court, Teva would be able to launch this product earlier in US market.

Posted by ADKS at 12:48 pm

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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