Where’s Generic Diovan? Ranbaxy’s Valsartan ANDA In Limbo As Novartis’ Patent Expires
This article was originally published in The Pink Sheet Daily
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.
You may also be interested in...
A Closer Look: Ranbaxy’s $500 Million Settlement Includes Criminal Penalties
The generic drug maker’s Ranbaxy USA Inc. subsidiary pleads guilty to seven felony counts brought in connection with a longstanding government investigation into data integrity issues and manufacturing violations at two Indian sites, but while the settlement eliminates some worries for the firm, operations still face the weight of a FDA consent decree.
Ranbaxy’s $500 Million Settlement Includes Criminal Penalties
The generic drug maker’s Ranbaxy USA Inc. subsidiary pleads guilty to seven felony counts brought in connection with a longstanding government investigation into data integrity issues and manufacturing violations at two Indian sites, but while the settlement eliminates some worries for the firm, operations still face the weight of a FDA consent decree.
Provigil Generic Exclusivity Dispute Keeps Lawyers Up At Night
Teva dropped its suit when FDA conceded the firm has 180-day marketing exclusivity for generic Provigil; Mylan then sued the agency claiming Teva lost its exclusivity rights with its acquisition of Cephalon.