drugset / Press release

Sun Pharma announces USFDA approval to market generic Protonix Tablets - Company gets its first 180 day marketing exclusivity on a first-to-file ANDA with para IV certification

2007-09-11 · 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 Protonix ® Tablets Company gets its first 180 day marketing exclusivity on a first-to-file ANDA with para IV certification Mumbai, September 11, 2007: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted final approval for the company’s Abbreviated New Drug Applicat ion (ANDA) to market its generic version of Wyeth’s Protonix ®, pantoprazole tablets. These generic pantoprazole tablets are AB-rated equivalent of Wyeth’s Protonix ® Delayed Release Tablets and include two strengths: 20 mg (base) and 40 mg (base). These strengths of Protonix ® have annual sales of approximately USD 2.3 billion in the US. Sun Pharma, being one of the first-to-file an ANDA for generic Protonix ® with a para IV certification, shares a 180- day marketing exclusivity. Pantoprazole is indicated for short term treatment of erosive esophagitis associated with GERD, maintenance of healing of erosive esophagitis and for treatment of hypersecretory conditions. The Company is currently evaluating its launch options. PROTONIX ® is a registered trademark of Wyeth Pharmaceuticals Inc 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 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]

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