ManagementDr Reddy's plans to launch Lipitor's generic version in US
Drug maker Dr Reddy’s Laboratories plans to launch generic version of the world’s largest selling anti-cholesterol medicine ‘Lipitor’ in the US market in the next 2-3 years.
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Lipitor, an anti- cholesterol drug from pharma major Pfizer Inc’s portfolio, has an annual market sales of over $12 billion (over Rs 56,000 crore).
“We have filed an application for approval from the US Food and Drug Administration"s for atorvastatin (the chemical name of Lipitor). Once we get the approval, we would launch it in the US market,” the Hyderabad-based Dr Reddy’s Laboratories COO Satish Reddy told reporters here.
According to company officials, the application is not a Para IV filing. Under the new drug application submitted to the US drug regulator"s approval, Para IV filing are those which seeks nod for launching the drug before expiry of patent.
Indian pharma major Ranbaxy has resolved a patent dispute with Pfizer and has planned to launch the same drug in the US market in November 2011 with an 180-day exclusive period.
Though, Dr Reddy’s Lab would not get the exclusivity for Lipitor but the company is hopeful about its sales in the US, the world’s largest drug market.
“There are still opportunities in Lipitor,” Reddy said.
According to industry experts, after the expiry of Lipitor"s patent, the sale value of drug would significantly come down from the existing $12 billion annually but in terms of volume it would be one of the best attractive proposition for the generic company.