Ranbaxy sues the US FDA for revoking two key drug approvals

Washington, 24 Mar, 2015: The Indian drug manufacturer Ranbaxy, based in Haryana, has sued the US Food & Drug Administration (US FDA) for allegedly wrongfully revoking the approvals to two of its key drugs — Valcyte (Roche) and Nexium (AstraZeneca) – which they claim is blocking “hundreds of millions of dollars in anticipated revenue.”

The FDA decision wrongfully punishes Ranbaxy for manufacturing deficiencies found at two Indian facilities in 2006 and 2008, Ranbaxy said in a complaint filed November 14 in federal court in Washington, and reported by Bloomberg.

Business Standard reported that Ranbaxy also named in the suit US Health Secretary Sylvia Burwell.

Ranbaxy had planned to start selling generic Nexium last May, when the drug lost patent protection. AstraZeneca, which had Nexium sales of $3.9 billion last year, had been bracing for competition that hasn’t materialized and the London-based drugmaker on November 6 boosted its financial forecasts as a result. Roche’s Valcyte, whose patent expires in March, had sales of $748 million last year, reported Bloomberg.

The FDA said on November 4 that it made a mistake in 2008 by granting Ranbaxy tentative approval to make the generics, according to the complaint. The FDA also rescinded Ranbaxy’s 180-day period to exclusively sell generic Valcyte, which treats a virus that afflicts transplant patients and people with AIDS.

“FDA has no power to correct an alleged ’mistake’ it made six years ago,” Ranbaxy said in the complaint. “Senior FDA officials — at the agency’s highest levels, in multiple offices of the agency — specifically considered and determined that those products were eligible” for tentative approval “despite the known compliance issues at the relevant facilities.”

Ranbaxy had struck a deal with AstraZeneca in 2008 to settle a patent infringement lawsuit, under which it gained the right to sell the generic version of Nexium. Patents on Nexium expire from this year to 2019, AstraZeneca has said.

The FDA finding also helped two of Ranbaxy’s competitors, according to the complaint. The exclusive sales period the company lost was granted to Hyderabad, India-based Dr. Reddy’s (DRRD) Laboratories Ltd. and the U.S. unit of Dublin-based Endo International Plc (ENDP), a decision Ranbaxy seeks to reverse in the lawsuit, the Bloomberg report said.

In the lawsuit, Ranbaxy said the US FDA’s move was arbitrary, capricious, contrary to law and in violation of constitutional rights. It also exceeded the agency’s statutory authority, the company added, said the standard.

“The agency issued its decision with no prior notice to Ranbaxy. It gave Ranbaxy no opportunity to comment on the issues raised. And, the agency had no power to issue its decision,” the lawsuit said.

Ranbaxy could have earned $200 million with six-month exclusivity for both drugs.

Last month, the company had agreed to pay $40 million in a case related to Texas Medicaid program.