US approval of heartburn drug after Ranbaxy version was withdrawn by regulators

The US Food and Drug Administration (FDA) has approved the first generic competitor to AstraZeneca’s Nexium (esomeprazole). The copycat version will be marketed by Ivax Pharmaceuticals, a subsidiary of Israeli generic behemoth Teva.

Generic competition for Nexium has been delayed because the FDA had granted a tentative approval – including 180 days’ market exclusivity – to Indian generics firm Ranbaxy. However, Ranbaxy also faces US import bans on products made in several of its Indian factories, meaning it couldn’t actually get its esomeprazole to the US to exercise this exclusivity.

In November 2014, the FDA withdrew Ranbaxy’s approval for both generic esomeprazole and a copy of Roche’s antiviral drug Valcyte (valganciclovir), opening the door to other generics manufacturers.

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