Ranbaxy working with US regulators for Lipitor launch
Ranbaxy Laboratories Wednesday said it is still working with US regulators to remove the ban imposed on it so that it can sell generic version of cholesterol lowering drug Lipitor in the American market, though it has less than three weeks left for the start of its marketing exclusivity.
New Delhi: Ranbaxy Laboratories Wednesday said it is still working with US regulators to remove the ban imposed on it so that it can sell generic version of cholesterol lowering drug Lipitor in the American market, though it has less than three weeks left for the start of its marketing exclusivity.
Being the first to file for a generic copy for Lipitor, the world's largest selling drug, Ranbaxy had got approval from USFDA to sell its version of the drug from November 30 with 180-days of exclusive marketing rights following expiry of Pfizer's patent.
"From our side we are working with both the regulators. If the resolution comes we would welcome and that's the way we would keep it for the time being," Ranbaxy CEO and Managing Director Arun Sawhney said during an investor conference call.
Ranbaxy and Pfizer had settled all of their litigations worldwide over the Lipitor patent in 2008. Pfizer had also granted Watson the right to sell an authorised generic version of Lipitor.
However, Ranbaxy ran into problems after the US Food and Drug Administration (USFDA) banned 30 generic drugs produced by it at the Dewas (Madhya Pradesh), and Paonta Sahib and Batamandi unit in Himachal Pradesh, citing gross violation of approved manufacturing norms in 2008.
Unless, Ranbaxy resolves the issues, it will not be able to launch its generic version of Lipitor in the US market.
While declining to give a specific reply on what the company plans to do in case the issue is not resolved, Sawhney said: "On regulatory front, Ranbaxy continues to cooperate and negotiate with the US regulators for a comprehensive resolution."
The company is working with US Food and Drug Administration (USFDA) and the Department of Justice for a comprehensive settlement to address its regulatory issues.
A blockbuster drug, Lipitor had sales of over USD 7.2 billion for the year ended September, 2010.
Sawhney said the company expects to launch an anti malaria drug in India towards the end of 2011 or early 2012.
"This will be the first ever new drug to be developed and launched by any Indian pharma company," he said.