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.
A
- Advanced Innovation Assessment
- An innovation assessment applying sophisticated methods, such as patent citation analysis or technology forecasting, to evaluate a new technology's significance.
D
- Data Exclusivity
- A period during which regulators cannot rely on an originator's trial data to approve a generic or biosimilar competitor, distinct from patent protection.
E
- Evergreening
- A strategy extending a product's effective market exclusivity beyond its original patent term, often through patents on minor formulation or indication changes.
F
- First Generic Entry
- The introduction of the first generic competitor after a brand-name drug's patent and exclusivity expire, typically bringing a substantial initial price cut.
L
- Lifecycle Plan
- A roadmap outlining a product's anticipated evolution over its market life, including planned label expansions and eventual patent expiration management.
- Lifecycle Pricing
- The strategy governing how a treatment's price is managed over its entire market life, from launch through patent expiry and generic competition.
M
- Market Exclusivity
- A period during which regulators will not approve a competing generic or biosimilar, arising from patent protection, regulatory provisions, or both.
P
- Paragraph Iv Certification
- A patent certification filed by a generic manufacturer asserting a listed patent is invalid or not infringed, initiating a process affecting generic entry timing.
- Patent
- A government-granted legal right conferring exclusive control over an invention, such as a new drug compound, for a defined period.
- Patent Application
- A formal legal request to a national patent office seeking exclusive rights to an invention, such as a new drug compound, for a defined period.
- Patent Challenge
- A legal action by a generic or biosimilar manufacturer disputing a reference product's patent validity, often a precursor to earlier market entry.
- Patent Cliff Management
- A manufacturer's strategic planning to manage expected revenue decline following patent expiry and generic competition for a key product.
- Patent Examination
- The formal review process by a patent office to determine whether a patent application meets requirements for novelty, non-obviousness, and utility.
- Patent Expiry
- The date on which a patent's legal protection ends, after which competitors are generally free to market equivalent products without infringement.
- Patent Extension
- An additional period of patent protection compensating a manufacturer for time lost during regulatory approval, delaying generic competition and price reductions.
- Patent Grant
- The formal act by which a patent office confers exclusive rights to an inventor for a defined period, following successful examination.
- Patent Life
- The total length of time a patent remains in force from filing to expiry, typically twenty years, though effective exclusivity is usually shorter.
- Patent Settlement
- An agreement between a brand manufacturer and a generic competitor resolving patent litigation, sometimes setting a negotiated generic entry date.
- Patent Term
- The total duration a granted patent provides exclusive rights, typically twenty years from filing, subject to extensions for regulatory review time.
- Price Erosion
- The gradual decline in a drug's price over time, most commonly following generic or biosimilar competition after patent exclusivity is lost.
S
- Supplementary Protection Certificate
- Additional EU intellectual property protection extending a patented drug's effective market exclusivity to compensate for time lost during regulatory review.