Generic Drug Facts

A generic drug is a medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics.

Generic medicines work the same as brand-name medicines

A generic medicine works in the same way and provides the same clinical benefit as its brand-name version. This standard applies to all FDA-approved generic medicines. A generic medicine is the same as a brand-name medicine in dosage, safety, effectiveness, strength, stability, and quality, as well as in the way it is taken and should be used.

The FDA Generic Drugs Program conducts a rigorous review to make sure generic medicines meet these requirements. In addition, FDA conducts 3,500 inspections of manufacturing plants a year, ensuring compliance with the agency's regulations on good manufacturing practices.

FDA staff also continually monitor drug products to make certain the medicines at all levels of the supply chain, from active pharmaceutical ingredients (API) to products being sold to consumers, are safe, effective, and high quality. In the event of reports of negative patient side effects or other reactions, the FDA investigates and, when appropriate, may require changes in how a medicine (both brand-name and generic versions) is used or manufactured.

Generic drugs must meet high standards to receive FDA approval

FDA requires drug companies to demonstrate that the generic medicine can be effectively substituted and provide the same clinical benefit as the brand-name medicine that it copies. The abbreviated new drug application (ANDA) submitted by drug companies must show the generic medicine is the same as the brand-name version in the following ways:

• The active ingredient in the generic medicine is the same as in the brand-name drug/innovator drug.
• The generic medicine has the same strength, use indications, form (such as a tablet or an injectable), and route of administration (such as oral or topical).
• The inactive ingredients of the generic medicine are acceptable.
• The generic medicine is manufactured under the same strict standards as the brand-name medicine.
• The container in which the medicine will be shipped and sold is appropriate, and the label is the same as the brand-name medicine's label.