generic drug
Noun: A generic drug is a medication that contains the same active pharmaceutical ingredient, is identical in dosage form, strength, route of administration, quality, and intended use as a previously patented brand-name drug. It is marketed after the patent and exclusivity rights for the original brand-name drug have expired.
A generic drug is approved for sale after demonstrating it is bioequivalent to the brand-name drug. This means it delivers the same amount of the active ingredient into a patient's bloodstream in the same amount of time. The term is used to distinguish these post-patent medications from their original, brand-name counterparts. - Generic drugs are subject to regulation by health authorities, such as the U.S. Food and Drug Administration (FDA).
- Generic Drug Approval Process: The regulatory pathway, often called an Abbreviated New Drug Application (ANDA) in the United States, which focuses on proving bioequivalence rather than repeating extensive clinical trials.
- Generic Drug Interchangeability: In many jurisdictions, pharmacists are permitted or required to dispense a generic version unless the prescriber specifically indicates "dispense as written."
- Generic (adjective): Referring to the non-branded, general class. (e.g., , ).
- Brand-name drug (noun): The original, patented drug sold under a proprietary trademark.
- Bioequivalent (adjective): Having the same biological effect in terms of rate and extent of absorption.
- Pharmaceutical equivalent (noun): A drug product that contains the same active ingredient(s) and is identical in strength, dosage form, and route of administration.
- Generic medication
- Generic pharmaceutical
- Non-proprietary drug
- "Go generic": When a brand-name drug loses patent protection and generic versions enter the market.
- The cholesterol medication is expected to go generic next year, which will lower costs significantly.
- "Generic substitution": The practice of dispensing a generic drug in place of a prescribed brand-name drug.
- State laws govern generic substitution at the pharmacy counter.
- when the patent protection for a brand-name drug expires generic versions of the drug can be offered for sale if the FDA agrees
- generic drugs are usually cheaper than brand-name drugs