Sun Pharmaceutical settles litigation for generic Gleevec in US

Sun Pharmaceutical Industries’ one of its subsidiaries 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 Abbreviated New Drug Application (ANDA) for a generic version of Gleevec, Imatinib Mesylate tablets. These tablets are indicated for the treatment of chronic myeloid leukemia. Under the terms of the settlement agreement, Sun Pharma’s subsidiary may launch its version of generic Gleevec in the United States on February 01, 2016. The agreement is subject to customary regulatory approvals. Sun Pharma’s subsidiary holds a tentative approval from the USFDA for its ANDA for a generic version of Gleevec. As per IMS, Gleevec had annual sales of approximately $2 billion in the US.