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FDA Approves First Generic Drug for Leukemia

Update Date: Dec 05, 2015 09:33 AM EST

The U.S. Food and Drug Administration (FDA) has approved the first ever generic version of the drug Gleevec, which is used to treat leukemia.

The federal agency will allow a subsidiary of Sun Pharmaceutical Industries Ltd. to sell imatinib meyslate in the 100-mlligram and 400-milligram pill forms. This drug will be used to treat chronic myeloid leukemia and unlike Gleevec, it will not set patients back $10,000 per month (for the 400 once-a-day milligram pill).

Sun Pharmaceuticals, which is based in Mumbai, India, announced that it will start selling the pill starting on Feb. 1 2016 in the U.S. Sun Pharmaceuticals is one of the top generic drugmakers in the world.

Gleevec has been sold by Novartis AG since it was approved a decade ago. It is the Swiss drugmaker's highest-selling drug, bringing in $4.75 billion in global sales last year. $2.5 billion was from the U.S. alone.

In order to prevent all patients from switching to imatinib meyslate, Novartis will try to limit the total number of patients who will be allowed to make the change.

Per The New York Times:

"Novartis, the world's biggest drug maker by revenue and a leader in cancer medicines, is aiming to limit the number of U.S. patients who immediately defect to generic Gleevec. 

Employing a common strategy of brand-name drugmakers whose blockbusters are going off patent, Novartis is offering patients with private insurance discount cards that set their monthly copayment at $10, with Novartis covering up to $30,000 a year of the pharmacy bill. Insurers would be on the hook for the remainder. The program isn't available to patients paying cash or insured under government health programs."

Pharmaceutical Suns can sell the generic version exclusively for six months.

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