Ranbaxy’s fight over generics with US FDA fails to block rivals

Ranbaxy filed lawsuit against USFDA on 11 Nov 2014 in the District of Columbia in the US over withdrawing tentative approvals for two drugs and to not allow other generic makers enter the market. After US FDA withdrew Ranbaxy approvals, the US drug regulator had granted Dr Reddy's Laboratories and US-based Endo International Plc the approval for making generic version of Valcyte.

Ranbaxy in its filing against the USFDA had sought the court’s temporary approval to overturn the FDA’s decision and also not allow Dr Reddy’s and Endo Pharmaceuticals the exclusivity period for marketing Valcyte which is used for treating viral eye infections in AIDS patients. A US district judge denied the company’s request to not allow other generic makers enter the market.

Ranbaxy was granted tentative approval for making exact copy of two drugs-Nexium and Valcyte in 2008 by US FDA. However earlier this month it was cited by FDA that the approval was granted in error and Ranbaxy’s Plant did not follow GMP. Hence FDA took the decision to withdraw tentative approvals. Apart from quashing the tentative approvals 180 day exclusivity period for Valcyte have also been taken back by USFDA which could have fetched Ranbaxy, sales of around $50 million in 180 days.

As per the US Federal Court "the Federal Food, Drug and Cosmetic Act doesnot permit FDA to revoke the issuance of a [tentative approval], and even if the agency did have such authority, it was not timely exercised.

Another case over the heartburn treatment Nexium in a pay-for-delay case is being fought by Ranbaxy at the Massachusetts Federal court. In this case AstraZeneca had agreed to accept hugely discounted damages payout for Teva's launch of drug Prilosec at $9 million against $20-30 million and in turn the agreement asked Teva to delay launching the generic for Nexium until May 2014. Until then Ranbaxy held the 180 day exclusivity and hence allegedly conspired with two companies so that no generic players enter the Nexium market. According to the law reports "shifting stance on the nature of the generic maker's antitrust liability" had led Ranbaxy to enter the case.