Sun Pharma announces USFDA approval to market generic Trileptal® Tablets, 180 day marketing exclusivity
2007-10-10 · Sun Pharmaceutical Industries, Inc. · original sunpharma.com ↗
17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (East), Mumbai 400 093 India Tel.: (91-22) 6645 5645 Fax.: (91-22) 6645 5685 Corporate Office : Acme Plaza, Andheri – Kurla Road, Andheri (East), Mumbai – 400 059. FOR IMMEDIATE RELEASE Sun Pharma announces USFDA approval to market generic Trileptal® Tablets Company gets 180 day marketing exclusivity on a first-to-file ANDA with para IV certification Mumbai, October 10, 2007: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted final approval for the company’s Abbreviated New Drug Application (ANDA) to market its generic version of Novartis Trileptal®, oxcarbazepine tablets. These generic oxcarbazepine tablets are AB-rated equivalent of Novartis Trileptal ® Tablets and include three strengths: 150 mg, 300 mg and 600 mg. These strengths of Trileptal ® have annual sales of approximately USD 640 million in the US. Sun Pharma, being one of the first-to-file an ANDA for generic Trileptal ® with a para IV certification, shares a 180- day marketing exclusivity. No action for patent infringement has been brought against Sun Pharma. Oxcarbazepine is indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures. The Company expects to reach the market shortly with these products. Trileptal ® is a registered trademark of Novartis. About Sun Pharma Established in 1983, listed since 1994 and headquartered in Indi a, Sun Pharma (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 formulations as branded generics as well as generics in India, US and several other markets across the world. In India, the company is a leader in niche therapy areas of psychiatry, neur ology, cardiology, diabetology, gastroenterology, and orthopedics. The company has strong skills in product development, process chemistry, and manufacturing of complex API, as well as dosage form s. 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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