Monday 1 June, 2009

Montelukast (Singulair) 10 mg tablets: Mylan announced tentative approval

Generic player Mylan has got tentative approval (as per Mylan press release Here ) to market Montelukast 10 mg tablets. Mylan got tentative approval on May 27, 2009. Mylan's generic version is bioequivalent to innovator Merck's Montelukast (Singulair) 10 mg tablets. As per IMS, Montelukast (Singulair) 10 mg tablets had total U.S. sales of approximately $2.6 billion for the 12 months ending March 31.

Mylan woyuld be able to market this product after the expiry of product patent US5565473 (in 2012).


Earlier, first para IV filer Teva got Tentative approval from USFDA on this product.


Earlier news of IP Pharma doc on this product Here

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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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