Ranbaxy to have exclusive Lipitor generic launch
pharmafile | June 19, 2008 | News story | Sales and Marketing | generics
Ranbaxy has secured a highly lucrative out-of-court settlement with Pfizer that allows it to launch a generic version of Lipitor ahead of any other company.
The deal is part of a larger agreement intended to end a long-running legal battle in which Ranbaxy has tried to overturn Lipitor (atorvastatin) patents in countries across the world.
The Indian generics company has taken an aggressive approach to challenging patents on some of the industry's biggest drugs, and the strategy seems to have now paid off in part.
The company stands to seize a huge tranche of the market from Pfizer from November 2011, and be the only producer of generic atorvastatin for the first three months in the US, with similar provisions in some other markets.
Malvinder Mohan Singh, chief executive of Ranbaxy, said: "This comprehensively settles outstanding issues between Ranbaxy and Pfizer, bringing to closure a number of ongoing patent disputes.
"It also provides certainty and visibility to the launch of Ranbaxy's generic atorvastatin, with 180-day market exclusivity in the US and an early entry in other markets. 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."
Ranbaxy will also have a license to sell atorvastatin on varying dates in seven other countries: Canada, Belgium, Netherlands, Germany, Sweden, Italy and Australia. Ranbaxy and Pfizer have also resolved their disputes regarding atorvastatin in Malaysia, Brunei, Peru and Vietnam.
Ranbaxy mounted its first patent challenges to Lipitor in 2003, but has now agreed to drop most of its legal proceedings.
The atorvastatin patents involved in this agreement are the basic compound patent, which expires in the United States in 2010; the enantiomer patent, which expires in the United States in 2011; and various process and crystalline form patents, which expire in 2016 and 2017; and the combination patent for fixed-dose combination product which expires in 2018.
The agreement also covers the fixed-dose combination of Atorvastatin-Amlodipine besylate (presently marketed as the brand Caduet, which also contains crystalline Form I atorvastatin), a fixed-dose combination product indicated for patients suffering from both high blood pressure and high levels of cholesterol. The patent for the fixed-dose combination expires in 2018.
The settlement also resolves additional patent litigation between the companies involving the branded drugs Accupril (in the US) and Viagra (in Ecuador) and all patent litigation with Ranbaxy relating to generic formulation of quinapril hydrochloride in the United States and sildenafil in Ecuador.
The companies could not agree to settle all of their patent battles over the drug, however. Litigation between Pfizer and Ranbaxy will continue in five other European countries – Finland, Spain, Portugal, Denmark and Romania.
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