MUMBAI, India and BALTIMORE, October 3, 2013 /PRNewswire/ --
Pharma Major Lupin Limited (Lupin) announced today that its US subsidiary, Lupin Pharmaceuticals, Inc. (LPI), has launched its generic Gatifloxacin Ophthalmic Solution, 0.5%. Lupin had earlier received final approval from the United States Food and Drugs Administration (US FDA) to market a generic version of Allergan Inc.'s Zymaxid™ Ophthalmic Solution, 0.5%.
Lupin's Gatifloxacin Ophthalmic solution 0.5% is the generic equivalent of Zymaxid™ Ophthalmic Solution of Allergan and is indicated for the treatment of bacterial conjunctivitis. Zymaxid™ Ophthalmic Solution, 0.5%, had annual U.S sales of approximately US$ 62.3 million (IMS MAT Jun 2013). Lupin was the first applicant to file an ANDA for Zymaxid™ Ophthalmic Solution and as such will be entitled to 180 days of marketing exclusivity.
Commenting on the approval, Nilesh Gupta, Managing Director, Lupin Limited, said, "Having received approval earlier, we are happy to now launch this product. The product is the first of the ophthalmic products that Lupin is bringing to the market and bears testimony to our continued commitment to serving our customers and patients by bringing high quality, affordable medicines."About Lupin Limited Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded and generic formulations and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership positions in the Anti-TB and Cephalosporin segment. Lupin is the 5th largest and fastest growing top 5 generics player in the US (5.3% market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by sales. The Company is also the fastest growing top 10 generic pharmaceutical players in Japan and South Africa (IMS). For the financial year ended March 2013, Lupin's Consolidated turnover and Profit after Tax were Rs. 94,616 million ( USD 1.74 billion) and Rs. 13,142 million ( USD 242 million) respectively. Please visit http://www.lupinworld.com for more information. Headquartered in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality, affordable generic medicines and branded formulations trusted by healthcare professionals and patients across geographies. For more information, visit http://www.lupinpharmaceuticals.com Safe Harbor Statement * Zymaxid™ is the registered trademark of Allergan Inc.