<em>Nexium</em> Generics: Ranbaxy’s Exclusivity Loss Is Teva’s Gain

Nexium Generics: Ranbaxy’s Exclusivity Loss Is Teva’s Gain

02 Feb 2015

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.

FDA’s declaration that Ranbaxy Laboratories Ltd. forfeited its generic marketing exclusivity rights on AstraZeneca PLC’s Nexium was triggered by a competitor’s readiness for approval; both developments suggest the growing importance of generic application quality for the agency.

On Jan. 26, FDA approved an ANDA submitted by Teva Pharmaceuticals USA Inc. subsidiary Ivax Pharmaceuticals Inc. for...