India’s Sun Pharmaceutical enters $2.5B US market with its generic version of Gleevec

Sun Pharmaceutical Industries, largest India-based generic pharmaceutical companies, has received approval from the US FDA for its Abbreviated New Drug Application (ANDA) for generic version of Novartis’ Gleevec.

Imatinib Mesylate tablets are therapeutic equivalents of Novartis’ tablets. Sun Pharmaceuticals said Friday that as per IMS MAT August 2015, these tablets have annual sales of approximately $2.5 billion in the U.S.

Under the terms of 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, when the company scheduled the commercial launch of this product.