ARTICLE
5 September 2025

Regulatory Exclusivity For
Medicinal Products In Europe (Video)

HL
HGF Ltd

Contributor

HGF is one of Europe's largest firms of intellectual property specialists in Europe, with 21 offices across the UK, The Netherlands, Germany, Austria, Switzerland and Ireland. The firm's trade mark attorneys, patent attorneys and IP solicitors provide an integrated IP solution for clients.
8 years of data exclusivity, followed by 2 years of market exclusivity.
United Kingdom Intellectual Property

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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.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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