Sun Pharma Launches Generic Version of Novartis’ GleevecBy
Sun Pharma has launched imatinib mesylate tablets, a generic version of Novartis’ anticancer therapy, Gleevec. Sun Pharma received final approval for imatinib mesylate from the US Food and Drug Administration in December 2015. Being a first-to-file product, it was granted 180 days of marketing exclusivity by the FDA from the time of its launch.
Sun received FDA approval for the drug for various indication, including as treatment for newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
Gleevec/Glivec was Novartis’ top-selling oncology drug in 2015 with sales of $4.66 billion.
In 2015, in the US, Novartis Pharmaceuticals Corporation settled its litigation with a subsidiary of Sun Pharmaceutical Industries Ltd. relating to Novartis patents covering the use of certain polymorphic forms of Gleevec/Glivec, which expire in 2019 (including pediatric exclusivity). The basic compound patent for Gleevec/Glivec expired in the US on July 4, 2015. As a result of the settlement, Novartis is allowing Sun's subsidiary to market a generic version of Gleevec/Glivec in the US commencing on February 1, 2016, according to Novartis’ fourth-quarter 2015 and 2015 earnings release.