TOKYO - Daiichi Sankyo Company announced on Thursday that Daiichi has prevailed in a patent infringement litigation in which Apotex was seeking the right to sell a generic version of Daiichi's antibiotic ear drop medicine FLOXIN Otic. FLOXIN Otic is the first antibiotic ear drop medicine ever approved by the Food and Drug Administration (FDA) for treating bacterial ear infections in pediatric and adult patients with a perforated eardrum.
The United States District Court for the District of New Jersey Judge William G. Bassler held that Daiichi's method of treatment patent (US Patent No. 5,401,741) is valid, enforceable and infringed by the generic manufacturer's product.
The decision, which is subject to appeal, prohibits Apotex from launching a generic version of ofloxacin otic solution, 0.3% until after the March 27, 2012 expiration date of the patent.
Daiichi Sankyo Company Ltd was established on September 28, 2005 as the joint holding company of two major Japanese pharmaceutical companies - Sankyo Co., Ltd. and Daiichi Pharmaceutical Co., Ltd. DAIICHI SANKYO is a Global Pharma Innovator, continuously generating innovative drugs and services and maximizing its corporate value.
