Sun Pharmaceutical announces launch of generic Ethyol ® (180 days exclusivity)

17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (East), Mumbai 400 093 India Tel.: (91-22) 6645 5645 Fax.: (91-22) 6645 5685 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 Pharmaceutical announces launch of generic Ethyol® Enjoys 180 day marketing exclusivity on this first-to-file ANDA with para IV certification Mumbai, March 31, 2008: Sun Pharmaceutical Industries Ltd. announced today that it has commercially launched generic Amifostine for injection 500mg, which is therapeutically equivalent to MedImmune’s Ethyol®. Sun Pharma’s product is being sold in the United States by it s marketing partner Caraco Pharmaceutical Laboratories. Sun Pharma had received a USFDA approval for this earlier in Mar 2008. Ethyol® has annual sales of approximately USD 80 million in the US. Sun Pharma, being the first-to-file an ANDA for generic Ethyol® with a para IV certification, has a 180-day marketing exclusivity. Ethyol® is covered under 3 patents - ‘471 (July 31, 2012), ‘731 (July 31, 2012) and ‘409 (Dec 8, 2017). This ANDA was filed with para IV certification against all the patents. Medimmune filed a suit in the District Court of Maryland and the case is under litigation. Ethyol® is a registered trademark of MedImmune Oncology, Inc. About Sun Pharmaceutical Industries Ltd. Established in 1983, listed since 1994 and headquartered in Indi a, Sun Pharmaceutical Indust ries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) is an international, integrated, speciality pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulat ions as branded generics as well as generics in India, US and several other markets across the world. In India, the compan y is a leader in niche therapy areas of psychiatry, neurology, cardiology, diabetology, gastro enterology, and orthopedics. The company has strong skills in product development, process chemistry, and manufacturing of complex API, as well as dosage forms. More information about the company can be found at www.sunpharma.com. Contacts Uday Baldota Mira Desai Tel +91 22 6645 5645, Xtn 605 Tel +91 22 6645 5645, Xtn 606 Tel Direct +91 22 66455605 Tel Direct +91 22 66455606 Mobile +91 98670 10529 Mobile +91 98219 23797 E mail [email protected] E mail [email protected]

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