RANBAXY-PFIZER GLOBAL SETTLEMENT

 

Pfizer and Ranbaxy both companies agreed to keep copies of  Lipitor off (an cholesterol drug) for an extra 20 month which would generate extra 20 $ billion for innovator company.  Under the agreement with Pfizer, Ranbaxy will introduce the copycat version of Lipitor and fixed dose combination of Atorvastatin -Amlodipine (Caduet in US) after Nov 2011. Earlier analyst had projected the entry of Ranbaxy’s generic product into the American Market after Mar 2010 when main patent expires, while Pfizer was seeking to delay the generic competition till 2016 (Crystalline form patent). Under the agreement, Ranbaxy will also have a license to sell Atorvastatin on varying dates in an additional 7 countries, including: Canada, Belgium, Netherlands, Germany, Sweden, Italy and Australia prior to 2-4 month of the main patent expiry. Ranbaxy and Pfizer have also resolved their disputes regarding Atorvastatin in Malaysia, Brunei, Peru and Vietnam. Such kind of settlement will generate revenue about 2.5 $ billion for the Indian company.

 

In addition, the lawsuits between Pfizer and Ranbaxy regarding Atorvastatin will be dismissed in select countries and the lawsuits between Pfizer and Ranbaxy regarding the fixed dose combination product containing Atorvastatin and amlodipine will be dismissed in the U.S. and Ranbaxy will no longer contest the validity of Pfizer's patents in such countries. Such patent challenges by Ranbaxy regarding Lipitor have been underway in numerous markets since 2003.

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 under 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 U.S.) 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.

Litigation between Ranbaxy and Pfizer relating to Lipitor will continue in five other European countries -- Finland, Spain, Portugal, Denmark and Romania.