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, India, 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 India, 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, neurology, cardiology, diabetology, gastroenterology, 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.