Asian Journal Of Social Pharmacy

Abstract: Objective To study the significance of authorized generic drugs due to the successive relevant documents issued by China’s government in recent years, which clearly stipulated that China should establish a drug patent linkage system. Methods The authorized generic drugs play an important role in keeping the balance between brandname drugs and generic drugs in the US. Therefore, this system was investigated, focusing on its difference from independent generics, marketing procedures, application in patent litigation and legitimacy analysis through case evidence. This analogy analysis could provide a reference for the research of authorized generic drug systems in China. Results and Conclusion As an important factor affecting the balance between brand-name drugs and generic drugs, authorized generic drugs should be comprehensively analyzed and discussed, and a suitable system for China’s national conditions should be established by referring to the experiences of the US.

Key words: authorized generic drug, patent linkage system, drug, settlement, patent litigation