What are generic drugs?

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What are Generic Drugs?

A generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, generic drugs are typically sold at substantial discounts from the branded price. According to the Congressional Budget Office, generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies. Even more billions are saved when hospitals use generics.

Health professionals and consumers can be assured that FDA approved generic drugs have met the same rigid standards as the innovator drug. To gain FDA approval, a generic drug must: contain the same active ingredients as the innovator drug (inactive ingredients may vary) be identical in strength, dosage form, and route of administration have the same use indications be bioequivalent meet the same batch requirements for identity, strength, purity, and quality be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products.

What’s the difference between a generic and brand-name drug?

Not much, except for name and price. A generic drug is called by its chemical name; a manufacturer assigns a brand name. The products have the same ingredients.

Standard practice and most state laws require that a generic drug be generically equivalent to its brand-name counterpart. That is, it must have the same active ingredients, strength, and dosage form—pill, liquid, or injection. Generic drugs also must be therapeutically equivalent—it must be the same chemically and have the same medical effect.

Do all drugs have generic equivalents?

Standard practice and most state laws require that a generic drug be generically equivalent to its brand-name counterpart. That is, it must have the same active ingredients, strength, and dosage form—pill, liquid, or injection. Generic drugs also must be therapeutically equivalent—it must be the same chemically and have the same medical effect.


 

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