Regulatory Exclusivity for
Medicinal Products in Europe

Video overview:

New Medical Products

8 years of data exclusivity, followed by 2 years of market exclusivity.
+1 year market exclusivity possible for a new indication showing significant clinical benefit.
No exclusivity granted for new formulations or routes of administration of the same active substance.

Orphan Drugs

10 years of exclusivity for treating rare diseases.
Exclusivity is indication-specific — multiple periods are allowed for different orphan indications.

Paediatric Exclusivity

Completing a Paediatric Investigation Plan (PIP):
Adds 6 months to the product’s SPC.
Or 2 years added to orphan exclusivity.

General Principles

Up to 11 years of protection for preclinical and clinical data used in marketing authorisation.
Regulatory exclusivity is independent of patents, offering a separate layer of protection.
Critical to assess exclusivity status when evaluating loss of protection or generic entry risk.