HGF Presents
Regulatory Exclusivity for Medicinal Products in Europe
September 2025
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.
