Generic Drug

A medication that is bioequivalent to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. Generics are typically sold under their chemical name rather than a brand name and are often less expensive than their branded counterparts.

 

Bioequivalence

Refers to the similarity in the rate and extent of absorption of the active ingredient(s) of a generic drug compared to a brand-name drug when administered at the same dose under similar conditions.

 

Active Ingredient

The chemical component responsible for the therapeutic effects of a medication. In generics, the active ingredient is identical to that of the brand-name drug.

 

FDA Approval

The process through which the U.S. Food and Drug Administration (FDA) evaluates the safety, efficacy, and quality of generic drugs before allowing them to be marketed and sold to consumers.

 

Patent Expiry

The point at which the patent protection for a brand-name drug expires, allowing generic versions to enter the market. This typically leads to increased competition and lower prices.

 

Therapeutic Equivalence

The concept that generic drugs have the same therapeutic effect as their brand-name counterparts when administered to patients under the same conditions.

 

Formulation

The specific combination of active and inactive ingredients, as well as the dosage form (e.g., tablet, capsule, injection), used to produce a medication. Generic drugs must have the same formulation as the brand-name drug to ensure bioequivalence.

 

Quality Control

The processes and procedures implemented by pharmaceutical manufacturers to ensure that generic drugs meet strict quality standards for safety, purity, and potency.

 

Cost Savings

The potential economic benefit of choosing generic drugs over brand-name drugs, as generics are typically priced lower due to reduced research and development costs.

 

Interchangeability

The ability of a generic drug to be substituted for its brand-name counterpart without compromising therapeutic effectiveness or safety. This concept is regulated by health authorities and may vary depending on the jurisdiction.