Ranbaxy Hurt in Bid to Reclaim Generic Nexium, Valcyte Approvals

A federal judge has sided with the FDA in its decision to strip Ranbaxy of generic approval and first-filer rights to Nexium and Valcyte, meaning company’s efforts to control the generic market for the two drugs could be over unless it appeals.

The U.S. district court judge for the District of Columbia on granted a request for summary judgment from the FDA opposing Ranbaxy’s bid to overturn the agency’s decision. The judge also denied Ranbaxy’s motion for a preliminary injunction against the FDA’s ability to implement the approval revocation. That, too, can be appealed.

Few details were available on the decision at press time because the judge’s rationale is sealed pending proposals for redactions from the opposing parties.

Ranbaxy has been fighting to reclaim its rights to generic Nexium (esomeprazole magnesium) and Valcyte (valganciclovir HCl) since the FDA determined that its tentative approval of the drugs was in error. According to the agency, the drugs should never have been approved in the first place due to rampant GMP problems at Ranbaxy’s India plants.

In response, Ranbaxy sued, arguing the FDA can’t rescind tentative approval over manufacturing quality issues. Other generics makers who stood to gain from marketing generic Nexium in the absence of a six-month exclusivity period joined the lawsuit, Ranbaxy Laboratories, Ltd. et al v. Burwell et al, to oppose Ranbaxy’s bid.

Generics of both Nexium and Valcyte have since hit the market.

Ranbaxy did not respond to a request for comment by press time. — Bryan Koenig