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.
E
- EvergreeningExclusivity Extension, Lifecycle Patent Extension
- A strategy extending a product's effective market exclusivity beyond its original patent term, often through patents on minor formulation or indication changes.
M
- Market ExclusivityMarketing Exclusivity, Data Exclusivity Period
- A period during which regulators will not approve a competing generic or biosimilar, arising from patent protection, regulatory provisions, or both.
O
- 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 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.
P
- Paediatric ExclusivityPediatric Exclusivity, Paediatric Extension
- An additional market exclusivity period granted for conducting requested paediatric studies of an already-approved product, incentivising paediatric-specific safety and efficacy data.
S
- Supplementary Protection CertificateCertificate of Supplementary Protection, Drug Patent Extension
- Additional EU intellectual property protection extending a patented drug's effective market exclusivity to compensate for time lost during regulatory review.