The practice of "authorised generics" has recently been the subject of considerable attention by the pharmaceutical industry, regulators, and members of Congress alike. An "authorised generic" (sometimes termed a "branded", "flanking", or "pseudo" generic) is a pharmaceutical that is marketed by or on behalf of a brand name drug company, but is sold under a generic name. Although the availability of an additional competitor in the generic drug market would appear to be favourable to consumers, authorised generics have nonetheless proven controversial. Some observers believe that authorised generics potentially discourage independent generic firms both from challenging drug patents and from selling their own products. This book presents an analysis of the innovation and public health issues relating to authorised generic drugs. The book begins 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.
It also provides detailed background information pertaining to the concept of authorised generics and assesses their potential impact upon patent challenges and consumer welfare, as well as a summary of congressional issues and possible alternatives.