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

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.

Patent expiration for one of the biggest branded products to lose exclusivity this year, Novartis AG’s Diovan (valsartan), came and went Sept. 21 without the launch of a competing generic for the single-ingredient antihypertensive agent.

The situation has raised questions about the ability of Ranbaxy Laboratories Ltd

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