首仿药的概念,最早来自美国,起源于1984年9月24日颁布的药品价格竞争与专利期补偿法案(Drug Price Competition and Patent Term Restoration Act,又称HatchWaxman法案)。该法案规定,在“专利无效或者批准正在申请的药物不会侵犯专利”的情况下,第一个向美国食品药品管理局(FDA)递交简化新药申请(Abbreviated New Drug Application,简称ANDA)的申请者将拥有180天的市场独占期。在这180天内,仿制药企业可以快速收回投资,并在市场被其他仿制药充斥之前确立其地位。因此, The concept of the first imitation drug, originally from the United States, originated from the Drug Price Competition and Patent Term Restoration Act (HatchWaxman Act) of September 24, 1984. The act states that the first to file an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) under the condition that “the patent is invalid or approves that the drug being applied does not infringe the patent” Of the applicants will have 180 days of market exclusivity. Within these 180 days, generic companies can quickly recover their investments and establish their position before the market is flooded with other generic drugs. therefore,