Nexium Patent Battle Could Switch To Generic Vs. Generic Fight
This article was originally published in The Pink Sheet Daily
Executive Summary
Teva obtains a license from AstraZeneca to begin marketing generic Nexium in May 2014 but may be delayed by Ranbaxy's exclusivity; Teva also withdraws appeal of ruling that upheld Merck's Singulair patent.
You may also be interested in...
Nexium Generics: Ranbaxy’s Exclusivity Loss Is Teva’s Gain
Teva’s readiness for approval prompts FDA conclusion that Ranbaxy forfeited its rights to 180-day exclusivity for AstraZeneca’s proton pump inhibitor; Ranbaxy is still making its case in court, but episode is suggestive of FDA’s increasing emphasis on application quality.
Ranbaxy Exclusivity Implosion Pushes Valcyte Generics Towards Launch; Nexium Remains ‘Very Hazy’
FDA rescinds Ranbaxy’s esomeprazole and valganciclovir ANDA tentative approvals because of GMP compliance issues; firm loses its 180-day marketing exclusivity for valganciclovir but not for esomeprazole.
Ranbaxy Exclusivity Implosion Pushes Valcyte Generics Towards Launch; Nexium Remains ‘Very Hazy’
FDA rescinds Ranbaxy’s esomeprazole and valganciclovir ANDA tentative approvals because of GMP compliance issues; firm loses its 180-day marketing exclusivity for valganciclovir but not for esomeprazole.