Sun Pharmaceutical Industries' subsidiary has executed a settlement agreement with Novartis Pharmaceuticals Corporation stipulating a dismissal of the lawsuits filed in the United States against the company regarding submission of an ANDA for a generic version of Gleevec, imatinib mesylate tablets. These tablets are indicated for the treatment of chronic myeloid leukaemia.
Under the terms of the settlement agreement, Sun Pharma’s subsidiary may launch its version of generic Gleevec in the US on February 1, 2016. The other terms of the agreement are confidential. The agreement is subject to customary regulatory approvals.
Sun Pharma’s subsidiary holds a tentative approval from the US FDA for its ANDA for a generic version of Gleevec. As per IMS, Gleevec had annual sales of approximately US$ 2 billion in the US. Gleevec is the registered trademark of Novartis Pharmaceuticals Corporation.