Generic drug

A medicine equivalent to a brand-name drug in active ingredient, strength, dosage form, and intended use. Regulators generally require evidence of comparable quality and performance before approving it.

Bioequivalence: A demonstration that two drug products deliver their active ingredient at sufficiently similar rates and amounts. It is the central evidence that a generic performs comparably to its reference drug.
Generic substitution: The replacement of a prescribed brand-name medicine with an equivalent generic product. It is the practical route by which generic approval can lower medicine costs.
Drug patent: A time-limited intellectual-property right that can protect an invention related to a medicine. Patent protection can delay generic entry even after a drug is developed.
Brand-name drug: A medicine marketed under a proprietary name, often by the company that first developed or licensed it. It is the reference category against which a generic is commonly described.
Pharmaceutical pricing: The processes and policies that determine the prices paid for medicines. Generic competition is one major force shaping medicine prices.
Pharmacokinetics: The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body. These measurements establish whether the generic produces comparable drug exposure.
Therapeutic equivalence: A determination that drug products are expected to have the same clinical effect and safety under labeled conditions. It guides whether a specific generic can substitute for its reference product.
Patent cliff: A sharp decline in revenue that can follow the loss of market exclusivity for a medicine. Generic competition often intensifies when key protections expire.
Authorized generic: A generic version marketed by the brand-name drug's original manufacturer, often with the same formulation as the branded product. It competes as a generic while originating from the brand manufacturer.
Pharmaceutical market exclusivity: A regulatory period during which a drug's sponsor receives protection from certain forms of competing approval. Exclusivity can postpone generic competition independently of patent rights.

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