Novartis Pharmaceuticals Corporation has settled its litigation with the United States subsidiary of Sun Pharmaceutical Industries Ltd. relating to Novartis patents covering the use of certain polymorphic forms of the anticancer drug Gleevec (imatinib mesylate), which expire in 2019 (including pediatric exclusivity). The basic compound patent for Gleevec expires in the US 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. The terms of the settlement agreement are otherwise confidential. Sun Pharma’s subsidiary has received tentative FDA approval for its generic version of imatinib mesylate.

Gleevec/Glivec had global sales of $4.69 billion in 2013.

Source: Novartis