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The US Food & Drug Administration (FDA) has approved Sun Pharmaceutical Industries Ltd’s abbreviated new drug application (ANDA) for imatinib mesylate tablets (100 mg and 400 mg), a generic version of Novartis’ Gleevec.
As per IMS MAT August 2015, these tablets have annual sales of approximately $ 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 US on February 1, 2016.
