ABSTRACT
Introduction ............................................................................................................ 334 Citizen Petitions and Legal Challenges to Generic Drug Approvals ..................... 335 Exclusivity Issues ................................................................................................... 337
Five-Year New Chemical Entity Exclusivity .................................................... 337 Three-Year Exclusivity for Product “Improvements” ....................................... 338 Seven-Year Orphan Drug Exclusivity ...............................................................340 180-Day Generic Drug Exclusivity ...................................................................340
