Research on the first generic drug system and the patent challenge strategy of USA
LIN Tao-xi
YU Na
HUANG Lu
Abstract：This paper introduces the first generic drug system of the United States from the perspectives of Drug Price Competition and Patent Term Restoration Act and the pharmaceutical patent linkage system,and briefly explains the patent term extension,marketing exclusivity,Orange Book,ANDA system,and patent challenging system.On this basis,this paper briefly introduces the patent strategy for development of first generic drugs from three aspects:project initiation,strategy,and paragraph statement confirmation.At last,this paper points out the enlightenment of the first generic drug system of USA for Chinese pharmaceutical enterprises which attempt to seize the first generic drug market of the United States.
Keywords：first generic drugBolar exceptionpharmaceutical patent linkage systempatent term extensionpatent challengepatent challenge strategy
Publication Date：2016-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)