Authorized Generic Drugs

Rising health care costs have for many years focused congressional attention upon the development and availability of prescription drugs. Recently, the presence of &quote;authorized generic&quote; pharmaceuticals in the drug marketplace has been the subject of congressional concern. An &quote;authorized generic&quote; is a pharmaceutical that is marketed by or on behalf of a brand-named drug company, but is sold under a generic name. The brand-name firm may distribute the drug under its own auspices or via a license to a generic drug company. The price of this &quote;authorized copy&quote; is ordinarily lower than that of the brand-name drug. Some sources refer to authorized generics as &quote;branded,&quote; &quote;flanking,&quote; or &quote;pseudo&quote; generics.&quote; This book presents an analysis of the innovation and public health issues relating to authorized generic drugs beginning with a review of the procedures through which independent generic drug companies receive government permission to market their products and resolve patent disputes with brand-name firms and consumer welfare.