Ranbaxy's Lipitor copy fate next week

NEW DELHI: A US court will decide next week if Ranbaxy Laboratories can launch its low-priced version of the world's best selling drug Lipitor in the American market in November.

A favourable ruling to India's largest drugmaker will mean a 180-day marketing exclusivity for selling its low-priced version of the cholesterol-lowering medicine in the US, which can result in sales of around $600 million in the first six months alone.

Ranbaxy's share price closed Rs 456.20, up 0.70% at the Bombay Stock Exchange in a weak Mumbai market on Friday.

American drugmaker Mylan moved the US District Court of Columbia early this month to get Ranbaxy's application of marketing exclusivity rejected, since it filed its application from Poanta Sahib plant in Himachal Pradesh (India).

Mylan said since US Food and Drug Administration (FDA) has banned products made in Poanta Sahib plant citing fabrication of data by Ranbaxy as a ground, the regulator must reject the Indian company's application. Ranbaxy is yet to get FDA's approval to launch the product.

Following a settlement with the original drugmaker Pfizer in 2008, Ranbaxy is allowed to start selling its generic version of Lipitor from November this year in the US, the world's largest drug market. Mylan and other generic drugmakers, including India's Dr Reddy's, plan to start selling their low-priced versions after Ranbaxy's six month exclusivity ends.