US court rejects Mylan plea against Ranbaxy

NEW DELHI: A US court has dismissed Mylan Inc’s attempt to prevent Ranbaxy Laboratories from launching a low-cost version of the world’s bestselling drug Lipitor in November , expected to bring $550-600 million windfall for the Indian firm. Mylan sought rejection of Ranbaxy’s application to US drug regulators as the Indian firm had filed its application for the medicine from its Poanta Sahib plant that is under scrutiny.

Ranbaxy wants six-month exclusivity to market its generic version of Pfizer’s drug Lipitor. US Foods and Drug Administration (FDA) had earlier penalised India’s largest drugmaker saying it fabricated data for applications made from the plant located in Himachal Pradesh.

Judge James Boasberg of the US District Court of Columbia said that Mylan's lawsuit was premature and had no legal standing as it did not suffer an immediate injury. He noted that Mylan wasn't the first to file an application to market a generic version of Lipitor and hasn't received tentative FDA approval of its application.

Both US FDA and Ranbaxy had opposed Mylan’s move. The Ranbaxy spokesman said the firm concurs with court’s ruling. But, this does not mean Ranbaxy has secured the US FDA nod to sell its drug as scheduled from November end. Although Ranbaxy has already entered into a patent suit settlement with the original drugmaker Pfizer Inc, the FDA is yet to approve its low-priced drug. US FDA has told the court that it would reach a decision as soon as practicable.