Generic Drug
A medication that contains the same active ingredient, dosage, and form as a brand-name drug, approved after the original's patent expires — typically costing 80-95% less.
How It Works
Generic drugs must prove bioequivalence to the brand-name drug through an Abbreviated New Drug Application (ANDA). The FDA requires that generics perform the same way in the body — same active ingredient, same strength, same dosage form, same route of administration. Inactive ingredients (fillers, binders, colors) may differ, which is why a generic pill may look different from the brand. Generic drugs account for about 90% of all prescriptions filled in the U.S. but only about 18% of total drug spending — a testament to how much cheaper they are. Every dollar spent on generic drugs saves the U.S. healthcare system approximately $8.50 compared to brand-name prices.
Related Terms
- Abbreviated New Drug Application (ANDA) — The FDA application pathway for generic drugs, which requires proving bioequivalence to the brand-name drug rather than repeating full clinical trials.
- Bioequivalence — A regulatory standard proving that a generic drug delivers the same amount of active ingredient to the bloodstream at the same rate as the brand-name drug.
- Patent Expiration — The date when a drug's patent protection ends, allowing generic or biosimilar manufacturers to produce competing versions.
Explore Drug Data
About This Definition
This definition is part of the DrugPrice Drug Pricing Glossary — 34 terms explaining how prescription drug pricing works in the United States. All definitions are written in plain language for patients, caregivers, journalists, and healthcare professionals.