The Impact of Data Exclusivity on the Pharmaceutical Industry

• Main Authors: Hsiao Fen Fan, 范曉雰
• Other Authors: Cherng Lee
• Format: Others
• Language: zh-TW
• Published: 2010
• Online Access: http://ndltd.ncl.edu.tw/handle/02461378896921359229

碩士 === 東海大學 === 管理碩士在職專班 === 98 === The products of pharmaceutical industry play an important role in human health, so governments have attached great importance to the pharmaceutical industry. Long-term development needs of pharmaceutical research and development and a variety of preclinical studies and clinical trials, in addition takes time, research and development costs staggering, there are very high risk of failure. An average time-consuming drug development needs of 12-15 years, about 5-10 million dollars into R & D costs, and market opportunities for successful new drug is only 1/5000. Governments are developed to improve the pharmaceutical industry will in order to enhance the pharmaceutical standards and improving the public health, in addition to patents, also provides the pharmaceutical industry many protections. This article by the pharmaceutical industry and the development process about, to gain insight into the pharmaceutical industry to get the exclusive, according to the system and the duration of the market. By further analysis of the U.S. domestic surveillance in the Orange Book and drug information to understand the data exclusivity in the United States and the domestic situation, and make recommendations on data exclusivity. The first chapter is an introduction, explains the motive and purpose, method and scope. The second chapter was to explore the development of the pharmaceutical industry, inspection and registration with various protection systems. Chapter third is to analyze the United States and domestic surveillance in the Orange Book in order to understand the new drug ingredient's role in new drug data exclusivity. Chapter fourth is devoted to domestic manufacturers of original brand and the exclusive rights to the information in response. Chapter five is the conclusions and recommendations.