Novartis settles patent litigation on Gleevec® (imatinib mesylate) with Sun Pharma subsidiary

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 Gleevec® (imatinib mesylate), which expire in 2019 (including pediatric exclusivity). 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. The terms of the settlement agreement are otherwise confidential. Sun Pharma’s subsidiary has received tentative approval from the US Food and Drug Administration (FDA) for its generic version of imatinib mesylate.

Patents are vital to the ability of innovative companies like Novartis to invest in high-risk research to advance breakthrough treatments for patients without treatment options. This settlement validates the Novartis patents while allowing Sun Pharma’s subsidiary to enter the market with its generic product.

Novartis is the first healthcare company with a global leadership position in both patented prescription and generic pharmaceuticals. Offering high-quality generics through its Sandoz division plays a critical role in the Novartis strategy of offering a complete range of treatment options to patients, physicians and healthcare providers worldwide.