Research and Reference of the Authorized Generic Drug System in the US

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.

Brief introduction for application of USA authorized generic drugs

The authorized generic drugs(AGs)are drug products marketed in the USA with the permission of sponsor or holder of the approved brand name drug(usually refers to an innovator drug).Other than the fact that it does not have the brand name on its label,it is the exact same drug product as the brand name product.In China,for those published comparator products of generic drug products,the market availability is the first question to affect the smooth development and investigation for the process of the re-evaluation of the generic drugs.In the present paper,we systemically elaborated the definition,classification and relevant background of the AGs,as well as their differences to the generic drugs.At the same time,by taking drug products,which are adopted in the Chinese comparator product directories for generic medicinal products(first batch)and sourced from USA orange book,as examples,we introduced the searching process of the AGs with the integration of FDA listing of AGs,the USA orange book and the USA national drug code directory.It can facilitate the domestic and foreign pharmaceutical enterprises to search,identify and purchase the corresponding AGs of the designated comparator product when question emerges to its market availability.