![]() We estimated additional years of exclusivity per drug per orphan approval using mixed-effects negative binomial regression. Drug costs throughout this time period were measured using IQVIA claims data. We analyzed a retrospective cohort of US orphan drug approvals filed between 19. We determined the prevalence of drugs with multiple orphan approvals, the duration for which manufacturers are able to maintain exclusivity using this mechanism, and the budget impact of these additional exclusivity periods on US spending on orphan drugs. By extending market exclusivity, manufacturers can forestall generic competition. ![]() The Orphan Drug Act extends exclusivity of branded drugs by 7 years for each rare disease approval.
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