Regulatory Exclusivity

Time-limited marketing protections granted by regulatory agencies that prevent approval of competing generic or biosimilar products, independent of patent status. Incentivizes pharmaceutical innovation by guaranteeing a period of market exclusivity. Types include New Chemical Entity exclusivity (5 years), Orphan Drug exclusivity (7 years), and Biologic exclusivity (12 years) in the US.

예시

• NCE 5-year exclusivity for new molecular entities
• 7-year orphan drug exclusivity for rare diseases
• 3-year new clinical investigation exclusivity for new indications