drugset / Press release

Sun Pharma announces settlement of litigation for generic Gleevec® in US

2014-05-15 · Sun Pharmaceutical Industries, Inc. · original sunpharma.com ↗

Sun Pharmaceutical Industries Ltd. 17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (East), Mumbai 400 093 India Tel.: (91-22) 6645 5645 Fax.: (91-22) 6645 5685 CIN: L24230GJ1993PLC019050 www.sunpharma.com Registered Office : SPARC, Tandalja, Vadodara – 390 020. India Corporate Office : Acme Plaza, Andheri – Kurla Road, Andheri (East), Mumbai – 400 059. India FOR IMMEDIATE RELEASE Sun Pharma announces settlement of litigation for generic Gleevec ® in US Mumbai, May 15, 2014: Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) today announced that one of its subsidiaries has executed a settlement agreemen t with Novartis Pharmaceuticals Corporation stipulati ng 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 o f 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 1, 2016. The other terms of the agreement are confidential. The agree ment 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. About Sun Pharma Established in 1983, listed since 1994 and headquartere d in India, Sun Pharmaceutical Industries Ltd. (Reute rs: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) is an international specialty pharmaceutical company with over 72% sales from global markets. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in US, India and several other marke ts across the world. For the year ending March 2013, overall revenues were at US$2.1 billion, of which US contributed US$ 1.1 billion. In India, the company is a leader in nic he therapy areas of psychiatry, neurology, cardiology, nephrology, gastro enterology, diabetology, orthopedics and ophthalmology . The company has strong skills in product development, process c hemistry, and manufacturing of complex dosage forms. Mo re information about the company can be found at www.sunpharma.com. Contacts Nimish Desai Frederick Castro Tel +91 22 6645 5645, Xtn 5717 Tel +91 22 6645 5645, Xtn 5964 Tel Direct +91 22 6645 5717 Tel Direct +91 22 6645 5964 Mobile +91 -98203 30182 Mobile +91 9 9206 65176 E mail nimish [email protected] E mail frederick .castro @sunpharma.com

The release as fetched from its publisher. sunpharma.com ↗