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 "authorised generic" pharmaceuticals in the drug marketplace has been the subject of congressional concern. An "authorised 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 "authorised copy" is ordinarily lower than that of the brand-name drug. Some sources refer to authorised generics as "branded," "flanking," or "pseudo" generics." This book presents an analysis of the innovation and public health issues relating to authorised 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.