India's leading drug maker Sun Pharmaceutical Industries is expected to make an additional revenue of $250-300 million from the generic version launch in the US of well-known blood cancer drug Gleevec.
Sun Pharma on Friday said one of its subsidiaries has received final approval from the US drug regulator FDA (Food and Drugs Administration) for its Abbreviated New Drug Application (ANDA) for generic version of Gleevec (Imatinib Mesylate) tablets 100 mg and 400 mg. The US Patents for Gleevec is with Swiss drug major Novartis.
"On a conservative basis, the product can easily contribute sales of around $250-300 million during the six-month exclusivity and net profit of around $75-90 million during the period", said Sarabjit Kour Nangra, Vice President, Research - Pharma at Angel Broking.
Under the terms of a settlement agreement with Novartis, the Sun Pharma subsidiary is permitted to launch its generics in the US on February 1, 2016.
Gleevec had made global headlines a few years ago following the Indian Patent office's decision to not allow a patent in India, citing it an incremental innovation. Novartis had a protracted court battle against the Indian Government, but lost finally in the Supreme Court.
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. Para IVs are marketing applications challenging the patent of a drug. The first generic company successfully challenging a patent will get six month exclusive sales in the US, upon patent expiry, as per the rules for generic drug sales in the US.
As per global drug sales tracking agency IMS, these tablets, indicated for the treatment of chronic myeloid leukemia, have annual sales of approximately $2.5 billion in the US.