The FDA has revoked two tentative generic drug approvals from manufacturer Ranbaxy Laboratories, for heartburn med Nexium (esomeprazole magnesium) and antiviral Valcyte (valganciclovir). Ranbaxy has had tentative approval to make these generics since 2008, but the final approvals were delayed due to long-standing issues with quality and compliance.
Earlier this year, the FDA banned all output from Ranbaxy’s India-based facilities due to quality concerns (see our previous post here), leaving only their New Jersey plant to produce highly anticipated generics like valsartan (generic Diovan). The ban and the shift to US-only production caused a significant delay in the availability of the Diovan generic.
The pulled approvals mean that Ranbaxy has lost their six-month exclusivity on the Valcyte generic, and likely on generic Nexium as well. When generic manufacturers apply for approval, the “first to file” is often given six months before any other companies are allowed to make a generic for the same drug. This is why you may not see generic prices start to drop until after a drug has had a generic available for a little while.
Now, what does this mean for you? First, there will definitely continue to be a delay in the release of both generics for the time being. Since it appears that Ranbaxy has lost their exclusivity period in both cases, other companies could file for approval and make them instead. It’s possible there will be generic versions of Nexium and Valcyte in the next year or two. However, Ranbaxy may try to hold on to their six month lead, particularly for Nexium.
Update: The FDA has granted full (not tentative) approval for generic Valcyte to two manufacturers: Dr. Reddy’s and Roche. The FDA also clarified that no companies have exclusivity for valgancicvlovir any longer. There isn’t a launch date available yet, but expect to see generic valganciclovir in pharmacies sooner rather than later.