Ranbaxy Laboratories, India's largest drugmaker, will launch a generic version of Pfizer's Lipitor, the world's top-selling cholesterol control drug, in the US by November, Tosumuto Ume, Ranbaxy chairman and chief executive of Daiichi Sankyo, Ranbaxy's majority owner, said in Tokyo on Thursday.
This opens up a big opportunity of around $500 million business for Ranbaxy, since it enjoys a six-month exclusivity period, Ume told the Nikkei newspaper.
After a studied silence on the issue of the US Food & Drugs Administration's permission, Ume finally made a positive, confident comment.
Ume said, "The company aims to start selling the generic version of Pfizer's cholesterol pill Lipitor on schedule in November and the quantum of fine would be much less than $1 billion.'' He denied reports that the marketing rights would be sold to a third party.
The Daiichi chief did not give any indications on the status of the FDA inspections, only saying that his statement on the scheduled launch was enough to boost confidence of shareholders. In fact, Ranbaxy's shares closed 4.37 per cent up on the Bombay Stock Exchange.
While it was the first time the company spoke of scheduled timelines for the drug, analysts feel the opportunity may still be muted due to the FDA penalty that looms large.