Rising health care costs have for many years focused congressional attention upon the development and availability of prescription drugs. Recently, the presence of "authorized generic" pharmaceuticals in the drug marketplace has been the subject of congressional concern. An "authorized generic" 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 "authorized copy" is ordinarily lower than that of the brand-name drug. Some sources refer to authorized generics as "branded, " "flanking, " or "pseudo" generics." 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.
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