Sun Pharmaceutical Industries Ltd, the country’s largest drugmaker by market capitalisation, has signed a settlement agreement with international drug major Novartis Pharmaceuticals Corporation to launch a generic drug in the US, the company informed the stock exchange on Thursday.
“Under the terms of the agreement, Sun Pharma’s subsidiary may launch its version of generic Gleevec in the US on February 1, 2016,” the announcement said.
The Mumbai-based drug major had applied in 2007 for marketing approval for generic imatinib mesylate tablets, which is sold by Novartis as Gleevec. India has denied patent to Novartis for this drug in 2006. It is used for treatment of chronic myeloid leukemia.
According to the release, Sun Pharma could launch the generic copy of the drug in the US in February 2016 subject to regulatory approvals.
The other terms of the agreement are confidential, the company said in the release.
At present, Sun Pharma holds a tentative approval from US FDA for its ANDA for a generic version of Gleevec. The drug has sales of around $2 billion in US, according to IMS.
“The deal has put clarity on the launch of the product and would fully reflect in the FY2017 financials. On a conservative basis, the product can contribute around $250 million and $75 million on sales and net profit, respectively, for the six-month exclusivity period,” said Sarabjit Kour Nangra, VP-Research, Pharma at Angel Broking.
(Edited by Joby Puthuparampil Johnson)