The 1984 Drug Price Competition and Patent Term Restoration Act (the Waxman-Hatch Act) is unique in many ways. This Law was the first change in U.S. patent terms since 1861. It simultaneously lowered the barrier to entry for generic drug firms and increased patent terms for new drugs delayed by...

We develop a simultaneous equations estimation framework to understand the interactions among generic entry, prices, and market shares. We base our estimates on a panel data sample of 40 brand-name drugs that first experienced generic competition during the period July 1992-January 1998. We find...

Patents for several blockbuster biological products are expected to expire soon. The Food and Drug Administration is examining whether biologics can and should be treated like pharmaceuticals with regard to generics. In contrast with pharmaceuticals, which are manufactured through chemical...