A balancing act in the United States Drug Industry: pioneer and generic drugs, the Orange Book, marketing protection and the US consumer

Abstract

This article reviews the range of laws and requirements that surround the creation, testing and marketing of pharmaceutical materials in the USA. It focuses in particular on the Orange Book––more formally Approved Drug Products with Therapeutic Equivalence Evaluations––and its role in the process of providing safe and effective drugs at reasonable cost for the consumer, while ensuring that the corresponding research and development in creating new drug products is rewarded. Specific topics covered include: the history and purpose of the `Orange Book', the legislative background, safety and effectiveness, therapeutic equivalence, Waxman-Hatch legislation, the patent position, various forms of exclusivity of marketing rights––such as orphan, Waxman-Hatch, and pediatric, and patent certification as part of an abbreviated new drug application.