Sun Pharma saw its shares rally 4% in a falling market, after one of the company's subsidiaries received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic version of Gleevec.
Imatinib Mesylate tablets 100mg and 400mg are the terapeutic 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.
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