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Mylan gains tentative OK on generic Benicar HCT

This article was originally published in Scrip

Executive Summary

The US FDAhas granted tentative approval to Mylan Laboratories’ ANDA for a generic version of Daiichi Sankyo's antihypertensive Benicar HCT (olmesartan medoxomil/HCTZ tablets) in three strengths. The product had annual US sales of about $535 million for the 12 months ending June 30th, and Mylan believes it has first-filer status and thus a potential 180 days of market exclusivity upon final FDA approval. Mylan's ANDA, filed in February 2007, contains a paragraph IV certification that the US olmesartan patent, expiring in April 2016, is invalid or will not be infringed. Daiichi Sankyo sued for infringement last year, and the patent litigation continues. Separately, Mylan gained tentative approval for its generic version of Sanofi-Aventis's Uroxatral ER (alfluzosin HCl extended release tablets), which had US sales of $168 million for the 12 months ending June 30th.

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