Pfizer, Ranbaxy settle Lipitor patent suit, delaying U.S. generic sales five years

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Pfizer and Ranbaxy finally resolve longstanding Lipitor battle. Source:  

Pfizer and generic drug manufacturer Ranbaxy Laboratories of Mumbai, India, and certain of its affiliates have entered an agreement to settle substantially all their patent litigation worldwide involving Lipitor, the popular cholesterol-lowering medicine.

Under the terms of the agreement, Ranbaxy will have a license to sell generic versions of Lipitor and Caduet in the U.S. effective Nov. 30, 2011. Caduet combines the active ingredients of Lipitor and Norvasc to treat high blood pressure and high cholesterol.

For the first time, the settlement provides shareholders of Pfizer and Ranbaxy, as well as patients, with substantial certainty regarding the date – Nov. 30, 2011 – for entry of a generic version of Lipitor in the U.S., according to the New York City-based Pfizer.

In addition, Pfizer said that the agreement provides a license for Ranbaxy to sell generic versions of Lipitor on varying dates in seven additional countries: Canada, Belgium, Netherlands, Germany, Sweden, Italy and Australia. Pfizer and Ranbaxy have also resolved their disputes regarding Lipitor in Malaysia, Brunei, Peru and Vietnam.

The lawsuits between Pfizer and Ranbaxy regarding Lipitor and Caduet will be dismissed in the specified countries, and Ranbaxy will no longer contest the validity of Pfizer’s patents in the specified countries, including the U.S., according to the agreement. Pfizer said the settlement also resolves all U.S. patent litigation with Ranbaxy relating to the hypertension drug Accupril.

The Lipitor patents involved in the agreement are the basic compound patent, which expires in the U.S. in 2010; the enantiomer patent, which expires in the U.S. in 2011; as well as various process and crystalline form patents, which expire in 2016 and 2017; and the combination patent for Caduet, which expires in 2018, according to Pfizer.

The patent infringement litigation between Pfizer and Ranbaxy relating to Lipitor will continue in five European countries -- Finland, Spain, Portugal, Denmark and Romania.

Pfizer’s Lipitor remains the largest selling drug of any kind worldwide – accounting for around 40 percent of the market for cholesterol management drugs by value, according to Research & Markets.