Dictionary

The Dictionary provides concise definitions of health economics terms, arranged alphabetically for quick reference. Use it to understand unfamiliar terminology or confirm the meaning of a specific term.

7 terms matching “Orphan Drug”

O

Orphan DrugRare Disease Drug, Orphan Medicine
A treatment developed specifically for a rare disease below a specified population threshold, eligible for special regulatory designation and incentives.
Orphan Drug DesignationODD, Special Regulatory Status, Orphan Designation
A regulatory status for a rare disease treatment, giving development incentives such as tax credits, fee waivers, and extended market exclusivity.
Orphan Drug IncentivesRare-Disease Incentives, Orphan Development Incentives
The regulatory and financial benefits offered to manufacturers developing rare disease treatments, including trial expense tax credits and extended exclusivity.
Orphan Drug PricingOrphan Pricing, Rare-Disease Drug Pricing
The pricing strategies applied to rare disease treatments, frequently priced far higher per patient than common-condition treatments given the smaller patient population.
Orphan Drug ThresholdOrphan Threshold, Higher Rare-Disease Threshold
The population size threshold defining a disease as rare or orphan for regulatory designation, varying somewhat across countries and jurisdictions.
Orphan ExclusivityOrphan Market Exclusivity, Orphan Drug Exclusivity
A market exclusivity period following orphan drug approval during which regulators generally will not approve a similar competing product for the same rare indication.

U

Ultra-Orphan DrugUltra-Orphan Medicine, Very-Rare-Disease Drug
A treatment for an extremely rare disease, an even smaller subset of orphan diseases, posing particularly acute evidentiary challenges.