Dr Reddy’s Dragged to Court by Pfizer

Drug manufacturer Pfizer took Dr Reddy’s Laboratories (DRL) to court to delay the launch of the Indian drug maker’s low-cost version of atorvastatin in the US market. Pfizer had filed a its filing before a local court in Delaware (US) on 27 December 2010 alleging that Dr Reddy’s plan to launch a generic version of the world’s best-selling medicine, sold under the Lipitor brand, will infringe upon its patent. Pfizer initiated the legal action after Dr Reddy’s notified that it had filed an ANDA with the American drug regulator to sell atorvastatin calcium tablets in 80 mg dosage forms. Pfizer asked the court to withhold approval of Dr Reddy’s drug until one of its many patents for Lipitor expires in January 2017. Pfizer had earlier sued Dr Reddy’s for alleged infringement of the same patent when the Indian drug maker sought the US Food and Drugs Administration’s nod to sell generic versions of atorvastatin calcium tablets in 10 mg, 20 mg, and 40 mg dosage forms. That case is pending with the same US court.

The world’s largest drug maker Pfizer earns over $12 billion from the global sale of Lipitor.

Pfizer had earlier tried to block Ranbaxy Laboratories from launching a generic version of Lipitor in the US, the world’s biggest drug market. Pfizer had in June 2008 settled for an out-of-court agreement with Daiichi Sankyo-owned Ranbaxy, allowing it to sell a low-priced version of the medicine from November 2011, when one of its key patents on the same drug expires. Ranbaxy now holds a six-month marketing exclusivity for its low-cost version of the product, as it was the first generic drug maker to challenge Pfizer’s patent for Lipitor.