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Where’s Generic Diovan? Ranbaxy’s Valsartan ANDA In Limbo As Novartis’ Patent Expires

This article was originally published in PharmAsia News

Executive Summary

Apparent first-filer Ranbaxy failed to receive ANDA final approval upon expiration of Novartis’ compound patent for the antihypertensive, raising questions as to whether the Indian company’s opportunity on generic Diovan will be compromised by its GMP consent decree with FDA.

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