Market protection: period in which generics cannot be marketed
Market protection is the period after data exclusivity ends during which a generic or biosimilar can be authorised but not placed on the market.
Under Article 10(1) of Directive 2001/83/EC it runs for two years after the eight years of data exclusivity, ending ten years after the reference product's first EU authorisation. It extends by one year, to eleven, if a new indication with significant clinical benefit is authorised within the first eight years. Generic companies use these years to complete their procedures and launch on the first possible day.
What goes wrong: assuming the extra year applies without checking that the indication was authorised in time and accepted as a significant benefit, and confusing market protection with patent or SPC expiry, which can fall later.
Under the new pharma package (not yet in force), baseline market protection falls from two years to one; extensions for unmet need, qualifying new active substances or a new indication allow up to 11 years in total; see exclusivity changes.
Used in
Generic and originator teams map protection expiry and plan market entry in the loss-of-exclusivity workflow.
Related terms
- Data exclusivity: regulatory data protectionData exclusivity is the eight years after a reference product's first EU authorisation in which generics cannot rely on its preclinical and clinical data.
- 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.
Last updated