Ranbaxy, Pfizer sign truce over Lipitor

Exactly a week after the promoters of Ranbaxy Laboratories sold their shareholding to Japanese drug maker Daiichi Sankyo, the Indian drug maker and US giant Pfizer announced that they have reached an out-of-court settlement on their litigation over the world’s largest selling drug, Lipitor (Atorvastatin). According to the settlement, Ranbaxy will launch its generic version of Lipitor, the $12.7-billion cholesterol-lowering medicine, and combination drug Caduet in November 30, 2011 in the US with exclusive marketing rights for 180 days, along with the innovator company. Industry estimates peg Ranbaxy’s revenue upside from the settlement for Lipitor at $1.5 billion over a four-year period up to May 2012. Ranbaxy (subject to litigation) was on course to launch its generic version of Lipitor in the US in March, 2010, 15 months ahead of its patent expiry in June, 2011. The settlement pushes back the launch date by 20 months, even though it eliminates all uncertainty regarding the launch date. In addition, Ranbaxy will also not receive any upfront payment from the out-of-court settlement. Says Prabhudas Lilladher’s pharma analyst Ranjit Kapadia: “The settlement brings certainty to Ranbaxy’s launch and will cut down litigation cost for Ranbaxy from tomorrow itself. However, the drug’s launch has been pushed back by 20 months, which means that Pfizer will get additional sales of around $20 billion during the extended period.”
Ranbaxy has described the deal as a win-win situation. “This is the largest and the most comprehensive out-of-court settlement ever in the pharma industry covering a total revenue of over $13 billion. The revenues will start kicking in from this year as we will be launching generic version of Lipitor in Canada this calendar year,” Ranbaxy Laboratories CEO and MD Malvinder Singh told ET. A senior Pfizer executive said the agreement clearly reaffirms the value and importance of intellectual property. The settlement was announced after Indian stock exchanges closed on Wednesday. Ranbaxy shares moved up 2.9% to Rs 598 during the day. According to industry estimates, Ranbaxy will get a revenue upside of around $1.5 billion from the Lipitor generic over a four-year period up to May 2012. Bulk of this revenue will be backloaded and is expected to accrue when Ranbaxy launches the drug in the US market in November, 2011. Lipitor generates annual sales of $8 billion in the US alone. In Canada, the drug rakes in about a $1 billion in sales every year. Caduet, a combination drug of Lipitor and hypertension drug Norvasc, has annual global sales of $400 million. In addition to the US and Canada, the Indian drug maker will also have the licence to sell Atorvastatin in six more countries - Belgium, Netherlands, Germany, Sweden, Italy and Australia - on different dates. Ranbaxy can launch its Atorvastatin 2-4 months ahead of patent expiry in these countries. Ranbaxy and Pfizer have also resolved their disputes regarding Atorvastatin in Malaysia, Brunei, Peru and Vietnam.