Data exclusivity: regulatory data protection
Data exclusivity is the eight years after a reference product's first EU authorisation in which generics cannot rely on its preclinical and clinical data.
It is set in Article 10(1) of Directive 2001/83/EC and Article 14(11) of Regulation (EC) No 726/2004. After eight years a generic application can be filed, but the product cannot be marketed until market protection ends, giving the familiar 8+2+1 formula. Separate one-year protection applies to data for a new indication of a well-established substance (Article 10(5)) and to data supporting a change of supply status (Article 74a).
Mistakes include counting from a national approval date rather than the first EU authorisation, and assuming a new strength or form restarts the period.
Under the new pharma package (not yet in force), data protection stays at eight years while market protection falls to one, with conditional extensions; see exclusivity changes.
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Planning teams research protection periods and document generic entry dates in the loss-of-exclusivity workflow.
Related terms
- Market protection: period in which generics cannot be marketedMarket protection is the period after data exclusivity ends during which a generic or biosimilar can be authorised but not placed on the market.
- Reference product: reference medicinal productThe reference medicinal product is the product, authorised in the EU on a full dossier, whose data a generic or hybrid application relies on.
- 8+2+1: EU data and market protection formula8+2+1 is the EU regulatory protection formula: eight years of data exclusivity, two years of market protection and one more year for a new indication.
- LoE: loss of exclusivityLoss of exclusivity (LoE) is the date when the last regulatory or patent protection on a medicine ends and generics or biosimilars can be marketed.
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