Market exclusivity: orphan medicines
Orphan medicines benefit from ten years of market exclusivity once they receive a marketing authorisation in the European Union (EU). This measure is intended to encourage the development of medicines for rare diseases, by protecting them from competition from similar medicines with similar indications, which cannot be marketed during the exclusivity period.
Market exclusivity is an orphan incentive awarded by the European Commission to a specific clinical indication with an orphan designation.
Each indication with an orphan designation confers ten years' market exclusivity for the particular indication.
A medicine that has multiple orphan designations for different conditions will benefit from separate market exclusivity periods pertaining to its different orphan designations.
To benefit from market exclusivity, a medicine must maintain its orphan designation at the time of marketing authorisation. For more information, see Applying for marketing authorisation of an orphan medicine.
Extension of market exclusivity period
The market exclusivity period is extended by two additional years for an orphan-designated condition when the results of specific studies are reflected in the summary of product characteristics (SmPC) addressing the paediatric population and completed in accordance with a fully compliant paediatric investigation plan (PIP).
The European Commission grants the extension based on a positive compliance check from the Paediatric Committee and opinion from the Committee for Medicinal Products for Human Use (CHMP), and includes this information in the Community register of orphan medicinal products.
For more information, see:
- Rewards and incentives for paediatric medicines
- Questions and answers on the procedure of PIP compliance verification at EMA, and on paediatric rewards
Review of market exclusivity period
Article 8(2) of the Orphan Regulation establishes the possibility for Member States to request that the market exclusivity be reduced from ten to six years, under certain circumstances. For more information see:
- Guideline on aspects of the application of Article 8(2) of Regulation (EC) No 141/2000 of the European Parliament and of the Council: Review of the period of market exclusivity of orphan medicinal products
Expiry of market exclusivity
When the period of market exclusivity for an indication ends, the orphan designation for that indication expires and the European Commission removes it from the Community register of orphan medicinal products.
Once all of the orphan designations associated with an approved medicine have expired or been withdrawn by the sponsor, the medicine ceases to be classified as an orphan medicine and no longer benefits from the orphan incentives.