Sun Pharmaceutical Industries Ltd today announced the signing of a settlement deal with US drug major Novartis allowing Sun Pharma's subsidiary to launch a generic version of the patented cancer drug Gleevec in the United States.
Sun Pharma said one of its subsidiaries executed the agreement with Novartis Pharmaceuticals 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 1 February 2016.
Sun Pharma said the other terms of the agreement are confidential and that 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 $2 billion in the US.
Sun Pharma, based in India, is an international specialty pharmaceutical company with over 72 per cent of its sales from global markets. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as
well as generics in the US, India and several other markets across the world.
For the year ended 31 March 2013, the company reported overall revenues of $2.1 billion, of which US contributed $1.1 billion.
In India, the company is a leader in niche therapy areas of psychiatry, neurology, cardiology, nephrology, gastroenterology, diabetology, orthopedics and ophthalmology.