Lawsuit Alleges Ranbaxy Filed Bogus ANDAs to Block Generic Competitors

Ranbaxy is being accused in federal court of filing ANDAs with false documentation in an effort to block generic competitors from coming to market.

The lawsuit, filed in the U.S. District Court for the District of Massachusetts, alleges that Ranbaxy exploited ANDA shortcuts to secure the coveted first-to-file generic status with its lucrative 180-day exclusivity period so that it could profit from undeserved monopolies, regardless of whether the drugmaker could promptly bring its generics to market.

For years, Ranbaxy filed ANDAs with the FDA based on false, fraudulent or forged data that omitted the fact that the company’s manufacturing processes couldn’t produce consistent generic products meeting required specifications, the complaint, Meijer, Inc. et al v. Ranbaxy Inc, et al, contends.

In 2007 and 2008, Ranbaxy misleadingly told the FDA that it was on the verge of bringing its Paonta Sahib, India, plant into compliance with current good manufacturing practices, but the problems were so extensive that plant remains out of compliance today, the complaint adds.

Meijer notes that the FDA obtained a consent decree against Ranbaxy in 2012 to address some of its compliance issues and the Justice Department imposed a $500 million criminal fine and civil penalty against the company in 2013.

The suit seeks monetary relief on behalf of direct purchasers who overpaid for Roche’s transplant drug Valcyte and Novartis’ heart drug Diovan because Ranbaxy’s wrongful conduct delayed generic entry of valganciclovir hydrochloride and valsartan.

Ranbaxy did not respond to a request for comment by press time. — Jonathon Shacat