US FDA approves India’s Sun Pharma for Novartis' Gleevec generic creation

The U.S. Food and Drug Administration approved Sun Pharmaceutical Industries Ltd to create a generic version of Novartis AG's Gleevec.

India's largest drugmaker announced Friday that it can now manufacture Gleevec, which the International Business Times describes as a treatment for a rare form of blood cancer called chronic myeloid leukemia. This drug accounted for $4.7 billion of Novartis' worldwide sales in 2014. It is considered as the drug makers best-seller.

Bloomberg has reported that Sun filed the application for the drug first, giving it eligibility to market the cancer treatment exclusively in the U.S. for six months. Sun's shares went up 3.9 percent to 754.95 rupees Friday 11:17 a.m. local time. Under the agreement with Novartis, Sun can roll out its generic version of drugs on February 1 next year.

Sun Pharma applied for the sale of Gleevec generic in the U.S. back in 2007. However, it was challenged by Novartis. Sun recently made an agreement with Novartis May. Sun's stock increased over 5 percent in the S&P BSE trading index Friday, after the approval was announced.

According to the Business Standard, the US patent of Novartis for Gleevec has expired July, which is why Sun was given the approval to sell in the country, where it gets half of its total revenue from.

Angel Broking vice-president Sarabjit Kour Nangra said that the product can easily bring $250-300 million and $75-90 million in sales and net profit respectively in the six-month exclusivity period, on a conservative basis. She said, "The product can easily enhance the earnings per share of the company in 2016-17 by eight to nine per cent."

As of February 1 2015, Gleevec made an annual sales of $2.5 billion in the United States alone.

Meanwhile, Dr. Reddy's Laboratories Ltd., which is another Indian drug manufacturer, also entered into an agreement with Novartis, launching the generic version of the Drug after Sun rolls out its own drug, according to Chief Operating Officer Abhijit Mukherjee.