Sun Pharmaceutical on Friday announced that one of its subsidiaries has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic version of Gleevec, which is used in treatment of chronic myeloid leukemia.
The Sun Pharma subsidiary 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.
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.
At 10.57 am, shares of the company were trading 4.43 per cent up at Rs 759.10.