ABSTRACT

CONTENTS 30.1 Introduction ......................................................................................................................533 30.2 R&D Costs for a New Drug Introduction ....................................................................535 30.3 The Hatch-Waxman Act: Balancing Innovative and Initiative Competition ..........536 30.4 Generic Competition Since the Act ................................................................................538 30.5 Are the Innovations and Imitation Costs of New Biotech Entities Different? ........539 30.6 Returns on R&D for New Drug Introductions ............................................................541 30.7 Conclusions and Policy Considerations ........................................................................543 References ....................................................................................................................................544