Can now launch a generic version of Gleevec

Pharmaceutical major Sun Pharmaceutical Industries has announced a settlement agreement with Novartis Pharmaceuticals Corporation to dismiss lawsuits filed in the U.S. against Sun with regard to its launch of the generic version of Novartis’ Gleevec.

A statement from Sun said its subsidiary had submitted the abbreviated new drug application (ANDA) for the Gleevec (Imatinib Mesylate tablets) generic version. Gleevec is used in the treatment of chronic myeloid leukemia.

Sun Pharma’s subsidiary has tentative approval from the U.S. regulator, US FDA (Food and Drug Administration), for the generic version of Gleevec.

Under the agreement, Sun Pharma’s subsidiary can launch its version of generic Gleevec in the U.S. market on February 1, 2016. The agreement is subject to customary regulatory approvals and the other terms of the agreement are confidential, Sun said.

As per IMS data, Gleevec had annual sales of about $2 billion in the U.S.. “We had factored launch of generic Gleevec in July 2015 and had factored revenues of $174 million for a nine-month period,” according to Rahul Sharma, a pharmaceutical sector analyst with Karvy Broking.

“With certainty of launch, we factor $82 million sales for a two-month period based on 30 per cent price erosion and a 35 per cent market share for a two-month period. We are prudent in our market share estimates as this is an oncology product and scale up may be slower.”

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