What are generic drugs?

A generic drug is a medication created to work in the same way as an already marketed brand-name medicine. It has the same dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. Generic drugs are medications that let you save money and get the same benefits as brand-name drugs.

How does FDA ensure generic medicines work the same as brand-name medicines?

The generic medicine must have no clinically meaningful difference from the brand-name medicine in dosage, form and route of administration, safety, effectiveness, strength, and labeling. Generic medicine must also meet the same high standards of quality and manufacturing as brand-name products, and it must be taken and used in the same way.

medicines contain the same active ingredients as brand-name medicines. Therefore, they also have the same risks and benefits as the brand-name medicines do. The FDA’s generic drugs program is rigorous, among other things inspecting manufacturing plants and monitoring drug safety after the generic medicine has been approved.

is important to mention that there will always be a minor, but not medically substantial, level of expected inconsistency—just as there is for one batch of brand-name medicine compared with the next batch of brand-name product. This variability can and typically does occur during producing, for both brand-name and generic drugs.

Why does a generic drug look different from the brand drug?

Unfortunately, in the United States, a generic medication cannot look exactly like a brand-name medicine due to trademark laws. Although, Generic medicines and brand-name medications have the identical active compounds.

Why do generic medicines often cost less than the brand-name medicines?

Generic drugs tend to cost less than their brand-name competitors because generic drug applicants do not have to repeat the same animal and clinical (human) studies that were required of the brand-name medicines to demonstrate safety and effectiveness as brand-name applicants have already approved the effectiveness of the active ingredients.

decrease in upfront research costs means that, although generic medicines have the same beneficial effect as their branded equivalents, they are typically sold at significant discounts, an estimated 80 to 85% less, compared with the price of the brand-name medicine.

Where can I find more information about generic medicines?

Contact your doctor, pharmacist, or other health care provider for information on generic medicines. For more information, you can also:

Visit the FDA Generic Drugs Program

Call 1-888-INFO-FDA