What the FDA requires of a generic medicine, what can differ from the brand-name version, and what to check when your medicine looks different.
What is a generic medicine?
When a company develops a new medicine, it usually sells it under a brand name while it holds patents and other exclusivity rights. Once those expire, other manufacturers can apply to make the same medicine. These versions are called generic medicines, and they are usually sold under the name of the active ingredient – for example ibuprofen rather than a brand name.
What the FDA requires
In the United States, a generic medicine must be approved by the Food and Drug Administration (FDA) before it can be sold. An approved generic must:
- Contain the same active ingredient as the brand-name medicine
- Have the same strength, dosage form (such as a tablet or capsule) and route of administration (such as by mouth)
- Be bioequivalent – it delivers the same amount of active ingredient into the bloodstream in the same amount of time
- Be made and tested to the same quality standards as brand-name medicines
That is why the FDA considers an approved generic to work in the same way, and to provide the same clinical benefit, as its brand-name version.
What can be different
- Inactive ingredients – fillers, colors and coatings can differ. If you have an allergy or intolerance to an inactive ingredient, such as a dye or lactose, check the label or ask a pharmacist.
- Appearance – trademark rules mean a generic can't look exactly like the brand-name medicine, so the shape, color or markings may be different.
- Price – generics usually cost less, partly because their manufacturers don't need to repeat the original clinical trials.
Over-the-counter products
The same idea applies to many over-the-counter products. Store-brand and brand-name products list their active ingredients and strengths in the Drug Facts label, so you can compare them directly.
If your medicine looks different
A tablet that looks different from your last supply often just means it comes from a different manufacturer. It is still worth checking: if you are unsure, or your prescriber has asked for a specific brand, ask your pharmacist before you take it.