未來(lái)5年內(nèi)全球有超過(guò)70個(gè)暢銷的專利藥陸續(xù)到期，這將為通用名藥市場(chǎng)帶來(lái)巨大的商機(jī)。橙皮書（Orange Book）是美國(guó)FDA為適應(yīng)《Hatch-Waxman法案》而設(shè)立的新藥專利鏈接制度。簡(jiǎn)要介紹橙皮書制度及相關(guān)通用名藥的簡(jiǎn)化新藥申請(qǐng)（abbreviated new drug application，ANDA）制度，并從嚴(yán)格制定認(rèn)證標(biāo)準(zhǔn)、尋求與品牌藥合作“授權(quán)仿制藥”、突破專利封鎖等方面分析橙皮書制度對(duì)我國(guó)制藥企業(yè)發(fā)展通用名藥市場(chǎng)的啟示。

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.