Mylan Inc sues USFDA to block Ranbaxy’s Lipitor bid

In a bid to block India's Ranbaxy Laboratories Ltd's bid to gain exclusive 180-day exclusive marketing rights to sell a generic version of Pfizer Inc's cholesterol pill Lipitor, Mylan Inc is suing the US Food and Drug Administration. Lipitor is the world's best-selling medicine.

In a complaint filed 18 March, in federal court in Washington, Mylan contends that it and other generic-drug makers should be allowed to enter the market as soon as Pfizer's patent expired. In an e-mail statement, Ranbaxy declined to offer comment on the lawsuit.

Ranbaxy, in which the Tokyo-based Daiichi Sankyo Co, holds a 64-per cent stake, was down the most in a month in Mumbai on speculation the US based company's move would hurt its prospects to sell the medicine in the world's largest drug market in November. According to the company, it is entitled to 180 days of marketing exclusivity as a reward for mounting the first challenge on Lipitor patents.

In an agreement with Pfizer in 2008, the Gurgaon-based company had obtained the right to sell copies of the medicine beginning in November. It has, though, not yet received the final regulatory approval on its application to sell the drug.

Mylan states in its case that Ranbaxy was not eligible for the marketing exclusivity because it had submitted false and unreliable data about its manufacturing facility in Paonta Sahib, India, where the Lipitor copies would be produced.

The company said it wrote to the FDA in January and February, and on 14 February met with agency officials to ask whether Ranbaxy's claim to the marketing exclusivity or the entire application would be denied due to improper information. According to the company, the FDA had failed to answer those questions.