Sun Pharmaceutical Industries Ltd.

Sun Pharmaceutical Industries’ subsidiary has received final approval from US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for generic version of Gleevec, Imatinib Mesylate tablets 100mg and 400mg.

Imatinib Mesylate tablets, 100 mg and 400 mg are therapeutic equivalents of Novartis’ Gleevec tablets. As per IMS MAT August 2015, these tablets have annual sales of around $2.5 billion in the US. These tablets are indicated for the treatment of chronic myeloid leukemia.

The Sun Pharma subsidiary, being the first-to-file an ANDA for generic Gleevec with a para IV certification, is eligible for 180-days marketing exclusivity in the US. Under the terms of a settlement agreement with Novartis, the Sun Pharma subsidiary is permitted to launch its version of generic Gleevec in the United States on February 1, 2016. The commercial launch of this product is scheduled for February 1, 2016.

Sun Pharma is the fifth largest specialty generic pharmaceutical company in the world. The company provides high quality, affordable medicines trusted by healthcare professionals and patients in over 150 countries worldwide.