Sun Pharmaceutical Industries Ltd. has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic version of Gleevec®, Imatinib Mesylate tablets 100mg and 400mg. Gleevec® is the registered trademark of Novartis Pharmaceuticals Corporation.
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 approximately US$ 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.
