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.
出处
《现代药物与临床》
CAS
2012年第5期484-487,共4页
Drugs & Clinic
关键词
橙皮书
通用名药
品牌药
简化新药申请
Orange Book
generic drug
brand-name drug
abbreviated new drug application （ANDA）
