美国橙皮书制度给我国发展通用名药的启示  

Revelation of Chinese generic drugs development from USA Orange Book

作　　者：陈娇[1,2] 王玉丽[1] 徐为人[1] 汤立达[1] 

机构地区：[1]天津药物研究院天津市新药设计与发现重点实验室,天津300193 [2]天津医科大学,天津300070

出　　处：《现代药物与临床》2012年第5期484-487,共4页Drugs & Clinic

摘　　要：未来5年内全球有超过70个畅销的专利药陆续到期,这将为通用名药市场带来巨大的商机。橙皮书(Orange Book)是美国FDA为适应《Hatch-Waxman法案》而设立的新药专利链接制度。简要介绍橙皮书制度及相关通用名药的简化新药申请(abbreviated new drug application,ANDA)制度,并从严格制定认证标准、寻求与品牌药合作"授权仿制药"、突破专利封锁等方面分析橙皮书制度对我国制药企业发展通用名药市场的启示。In the next five years, more than 70 best-selling patented drugs will be expired, which would bring the huge opportunities for the development of generic drugs market. The Orange Book is the new drug linkage system established by USA FDA to adapt to the Hatch-Waxman Act. This article gives a brief description of this system and the related abbreviated new drug application （ANDA）. Revelation of Chinese generic drug development from USA Orange Book is analyzed by making strict certification standard, seeking cooperation with the brand-name drug companies, and breaking the patent blockade.

关 键 词：橙皮书 通用名药 品牌药 简化新药申请 

分 类 号：R926[医药卫生—药学] R951