Sun Pharmaceutical announces USFDA approval to market generic Ethyol ® (With 180 day marketing 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 USFDA approval to market generic Ethyol® Receives 180 day marketing exclusivity on a first-to-file ANDA with para IV certification Mumbai, March 15, 2008: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted approval for the Abbreviated New Drug Application (ANDA) to market a generic version of MedImmune’s Ethyol®, amifostine f or injection 500mg. This generic amifostine for injection is therapeutically equivalent to MedImmune’s Ethyol® amifostine for injection 500mg. 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. Amifostine is used as an adjuvant in cancer treatment. Sun Pharma’s amifostine for injection will be indicated for the reduction of kidney damage in patients who have ad vanced ovarian cancer and are being given repeat doses of cisplatin. 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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