FDA insists Indian companies to adopt quality culture
Singapore: Novartis Pharmaceuticals has reported to settle its litigation with US subsidiary of India based Sun Pharmaceutical Industries relating to Novartis patents covering the use of certain polymorphic forms of Gleevec (imatinib mesylate), which expire in 2019.
The basic compound patent for Gleevec expires in the U.S. on July 4, 2015. As a result of the settlement, Novartis will permit Sun Pharma's subsidiary to market a generic version of Gleevec in the United States on February 1, 2016.
Sun Pharma's subsidiary has received tentative approval from the US Food and Drug Administration (FDA) for its generic version of imatinib mesylate.
