A period from the initial authorisation of a medicine during which the marketing authorisation holder benefits from the exclusive rights to the results of preclinical tests and clinical trials on the medicine. After this period, the marketing authorisation holder is obliged to release this information to companies wishing to develop generic versions of the medicine. In the European Union, there is data exclusivity of eight years (as of 2025).
Last update: 20 May 2025
Source: EMA 2025