Market exclusivity in orphan medicines in Europe Union

Published by EMA

Orphan IncentivePaediatric IncentiveMarket ExclusivityIncentive

This guide provides an incentive of EMA. Orphan medicines once they receive a marketing authorisation in EU, they benifit additional 10 years of market exclusivity regardless patent expiration. This incentive is to encourage the development of medicines for rare diseases to prevent from other competitors selling similar medicines for similar diseases. If the orphan medicines are intended for paediatric population, the market exclusivity is extended by two additional years for an orphan designated condition.

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