Data exclusivity is a period during which a medicines regulator may not rely on the clinical trial data submitted by an originator to approve a competitor’s generic or biosimilar version. It is distinct from patent protection and runs independently of it: a product whose patent has expired or was never granted can still be shielded, because the barrier is the regulator’s inability to use the dossier rather than any right over the invention. That makes it a creature of each country’s own medicines law, and the periods, the scope and even whether the protection exists vary by jurisdiction. There is no international instrument defining it — the nearest treaty language concerns protection of undisclosed test data against unfair commercial use, which is not the same obligation and is read differently by different states. Establish the regime in the market you care about; nothing generalises.
Why this entry carries no source list. This lexicon cites an official primary source wherever one exists and says plainly where none does. No body defines this term. Pointing at a regulator that happens to use it, or at a ratings provider’s methodology, would present one participant’s usage as a general rule.