Ranbaxy sued US FDA over withdrawal of approvals for generic drugs Nexium and Valcyte

Indian drug maker Ranbaxy Laboratories Ltd on 14 November 2014 sued the U.S. Food and Drug Administration (US FDA) over withdrawal of approvals for generic copies of anti-ulcer drug Nexium and HIV infection drug Valcyte.

Ranbaxy filed the suit in the District Court for the District of Columbia on the ground that the move of FDA was violative of constitutional rights and exceeded the agency's statutory authority. Further the revoking order was arbitrary, capricious, and otherwise contrary to law.

Ranbaxy also requested the court to restrain FDA from approving any other generic versions of Valcyte or Nexium until its six-month market exclusivity on the launch of the drugs ends.

Meanwhile, FDA after revoking Ranbaxy's tentative approvals, granted final approval to another Indian generic drug maker Dr Reddy's Laboratories Ltd and U.S.-based Endo International Plc to launch copies of Valcyte.

Ranbaxy was expected to hugely benefit from the launch of the generic versions of the two drugs.

According to market analysts, generic version of Nexium was expected to contribute about 150 million US dollars to Ranbaxy's revenue in the first six months of market exclusivity, while Valcyte was expected to bring in 40 million US dollars to 50 million US dollars.

Background

Earlier on 4 November 2014, US FDA had revoked the previously granted approval for these two drugs. Besides, FDA also had revoked six-month market exclusivity for Valcyte in US market.

Since 2008, Ranbaxy, which was acquired by Sun Pharmaceuticals for 3.2 billion US dollars, has been looking for revival after FDA had banned its Indian manufacturing plants Poanta Sahib in Himachal Pradesh and Mohali in Punjab from exporting to that market due to failure in manufacturing standard compliances.