Case Details

Year Initiated/Committed


Year Resolved


Settlement Amount




Docket Number

Assurance 14-034

Lead State


Participating States



Ranbaxy Pharmaceuticals, Inc.; Teva Pharmaceuticals USA

Case Description

Ranbaxy, a pharmaceutical company, was the first to seek to market a generic statin (atorvastatin calcium) equivalent to Lipitor. The FDA suspended scientific review of Ranbaxy drugs manufactured at certain facilities and Ranbaxy was concerned that it would not be able to market its generic atorvastatin. Ranbaxy entered into an agreement with another generic manufacturer, Teva, under which Teva would be allowed to launch its generic atorvastatin and the two companies would share the profits. However, this agreement also contained a provision providing that neither company would challenge any of each other’s abbreviated new drug applications (ANDAs), rather than just the ANDA for generic atorvastatin, for a period lasting for several years. The state alleged that this was the equivalent of an agreement not to compete or a market division agreement. The parties agreed to drop the provision relating to challenges to ANDAs and not to enter into similar agreements with other generic companies. They also agreed to make a payment to the state “in consideration of the making and execution of the Assurance.”