Generic drug
A bioequivalent copy of a small-molecule drug after its patent and exclusivity expire.
Definition
A generic drug contains the same active ingredient, dosage form, strength, route of administration, and intended use as a brand-name drug. It must demonstrate bioequivalence (typically Cmax and AUC within 80–125% of the reference) and is approved via an Abbreviated New Drug Application (ANDA), avoiding repeat efficacy trials.
See also
- Biosimilar — A biologic product highly similar to an already-approved reference biologic.
- ANDA — The FDA pathway for approving a generic copy of a previously-approved small-molecule drug.
- Paragraph IV — A generic manufacturer's certification that a brand drug's patents are invalid or not infringed.