FDA Regulatory Exclusivity for Drugs and Biologics: Overview | Practical Law
An overview of regulatory exclusivity for drugs and biologics approved by the Food and Drug Administration in new drug applications or biologics license applications. This Practice Note discusses new chemical entity exclusivity, new product exclusivity, qualified infectious disease product exclusivity, reference product exclusivity, orphan exclusivity, and pediatric exclusivity. It does not discuss exclusivity available for generic drugs or biosimilars.