Generic

Generic refers to a term used in the pharmaceutical industry to describe drugs that are marketed without a brand name, under their chemical name. These drugs are usually less expensive than brand-name drugs and are considered bioequivalent to the brand-name version in terms of dosage, strength, quality, performance and intended use.

Overview

A generic drug is a medication that has exactly the same active ingredients as the brand-name drug and yields the same therapeutic effect. It is the same in dose, strength, route of administration, quality, performance characteristics, and intended use. The Food and Drug Administration (FDA) describes generic drugs as being identical, or bioequivalent, to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.

Cost of Generic Drugs

Generic drugs are usually less expensive than their brand-name counterparts because they do not carry the same development costs as the brand-name drugs. The manufacturers of generic drugs do not have to repeat the costly clinical trials of new drugs and generally do not pay for costly advertising, marketing, and promotion. In addition, multiple generic companies are often approved to market a single product, which creates competition in the marketplace, often resulting in lower prices.

Safety and Effectiveness

The FDA requires that all drugs be safe and effective. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risk-benefit profile as their brand-name counterparts.

Bioequivalence

Bioequivalence does not mean generic drugs must be exactly the same as the brand-name product (pharmaceutical equivalent). They must be equivalent in terms of pharmacokinetics and pharmacodynamics properties. This means that the generic drug must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the brand-name drug.

See Also

• Brand-name drug
• Pharmaceutical industry
• Food and Drug Administration
• Pharmacokinetics
• Pharmacodynamics

Generic Resources
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