Frequently Asked Questions About Generics

Generic pharmaceutical manufacturers must prove to the FDA that their version of a drug:

• Contains the same active ingredient
• Is identical in strength, dosage form, and route of administration
• Has the same indications, dosing, and labeling
• Provides the same efficacy and safety profile to patients (“bioequivalent”)

Generic medicines have to be safe and effective to be approved by the FDA. The FDA also requires generic manufacturers to:

• Meet the same batch-to-batch requirements for strength, purity, and quality as the original manufacturer
• Follow the same strict “Good Manufacturing Practices” rules

U.S. trademark laws don’t allow generic drugs to look exactly the same as another drug already on the market. For that reason, the color and shape of a generic pill may be different than the brand-name. Sometimes it will have a different coating or flavor. These “inert ingredients” also are carefully considered by the FDA. Differences in taste or appearance do not affect the drug’s safety or effectiveness.

Some brand-name manufacturers charge customers higher prices in the United States than they do in other countries, where drug prices are regulated. Drug research is costly, and patent protection gives brand-name manufacturers a number of years with exclusive product rights to recover those costs-costs that generic manufacturers do not have. Brand-name manufacturers collectively spend billions of dollars in marketing new drugs to doctors and the public; they send their representatives to visit with doctors in their offices; and they pay for physicians’ trips to meetings and conferences to talk about their drugs with other doctors. Generic manufacturers rarely spend money on promotional activities that brand companies undertake – another important way they keep their costs down.

The easiest way to find out is to simply ask your doctor or pharmacist. There are also online resources.

Find Out More Information for Consumer: Generic Drugs

Questions and Answers
From Food And Drug Administration (FDA)
https://www.fda.gov/drugs/buying-using-medicine-safely/generic-drugs