NEW YORK (AP) -- Pfizer Inc. and India's Ranbaxy Laboratories Ltd. said Wednesday they have settled their patent dispute over the blockbuster cholesterol drug Lipitor, delaying the release of generic versions in the United States until Nov. 30, 2011.
Pfizer's Lipitor is the world's best-selling drug, generating nearly $13 billion in 2007 sales.
''The agreement provides patients with access to a generic product much earlier than if Ranbaxy were unsuccessful in obtaining approval for its product and overcoming the relevant patents,'' said Ian Read, president of worldwide pharmaceutical operations for Pfizer. He said it gave more certainty to the timing of the entry of a generic version of Lipitor.
Under terms of the deal, Ranbaxy will also be able to sell generic versions of Lipitor in Canada, Belgium, the Netherlands, Germany, Sweden, Italy and Australia. Pfizer and Ranbaxy have also resolved their disputes regarding Lipitor in Malaysia, Brunei, Peru and Vietnam, and regarding hypertension drug Accupril in the United States and Viagra in Ecuador.
The settlement provides Ranbaxy with licenses to all the patents it needs to make the generic version and enables Ranbaxy to make and launch a generic before Lipitor's crystalline and amorphous patents expire in 2016 and 2017.
''This comprehensively settles outstanding issues between Ranbaxy and Pfizer bringing to closure a number of ongoing patent disputes,'' said Malvinder Mohan Singh, chief executive of Ranbaxy. ''This will make the world's largest selling drug more accessible to patients who will gain from the timely availability of an affordable quality option.''
Pfizer and Ranbaxy have been locked in dispute regarding Lipitor patents since 2003. As the first generic challenger to Lipitor patents, Ranbaxy wins rights to 180 days of marketing exclusivity in the U.S.
Patent infringement litigation between Pfizer and Ranbaxy over Lipitor will continue in Finland, Spain, Portugal, Denmark and Romania.
