Today, nearly 8 in 10prescriptions filled in the U.S. are for generic drugs.

FACTS ABOUT

GENERIC DRUGS

GENERIC SAME QUALITY &

PERFORMANCE

FDA requires generic drugs to have the same active ingredient, strength, dosage form, and route of administration as the brand-name drug.

The generic manufacturer must prove its drug is the same (bioequivalent) as 

the brand-name drug. 

All manufacturing, packaging, and testing sites must pass the same quality 

standards as those of brand-name drugs.

Many generic drugs are made in the same manufacturing plants as the 

brand-name drugs.

BRAND
Any generic drug modeled after a single, brand 

name drug must perform approximately the same 

in the body as the brand name drug. There will 

always be a slight, but not medically important, 

level of natural variability just as there is for one 

batch of brand name drug compared to the next 

batch of brand name product.

This amount of difference would be expected and 

acceptable, whether for one batch of brand name 

drug tested against another batch of the same 

brand, or for a generic tested against a brand 

name drug.

ALL FDA-APPROVED GENERIC DRUGS

MUST BE EQUIVALENT TO THE BRAND-NAME DRUG.

$ $$$

$$$ $

In 2010 alone, the use of FDA-approved 

generics saved $158 billion.

80-85% LESS

Average cost of a generic drug 

vs. its brand-name counterpart

 Sun Mon Tues Wed Thurs Fri Sat

$3 billion saved every week!
FDA MONITORS ADVERSE EVENTS

REPORTS FOR GENERIC DRUGS.

Generic manufacturers are able to sell their products for lower 

prices because they are not required to repeat the costly 

clinical trials of new drugs and generally do not pay for costly 

advertising, marketing, and promotion  In addition, multiple 

generic companies apply to FDA to approve a generic for the 

same brand name drugs. Multiple generic companies are 

often approved to market a single product. Competition in the 

market place, often results in lower prices.

The monitoring of adverse events for all drug products, 

including generic drugs, is one aspect of the overall FDA

effort to evaluate the safety of drugs after approval. Many 

times, reports of adverse events describe a known

reaction to the active drug ingredient.

Reports are monitored and investigated, when appropriate. 

Investigations may lead to changes in how a product is used 

or manufactured.

THE LOWER PRICE 

DOESN’T MEAN INFERIOR.

$ $$$

FDA IS ACTIVELY ENGAGED IN

MAKING GENERIC DRUGS SAFER.

FDA is aware that there are reports that some people may experience an undesired 

effect when switching from a brand name drug to a generic formulation or from 

one generic drug to another generic drug. FDA wants to understand what may 

cause problems with certain formulations if, in fact, they are linked to specific 

generic products.

FDA is encouraging the generic industry to investigate whether, and under what 

circumstances, such problems occur. The Agency does not have the resources to 

perform independent clinical studies and lacks the regulatory authority to require 

industry to conduct such studies. FDA will continue to investigate these reports to 

ensure that it has all the facts about these treatment failures and will make 

recommendations to healthcare professionals and the public if the need arises.

1

Davit et al. Comparing generic and innovator drugs:

a review of 12 years of bioequivalence data from the United States Food and Drug Administration.

Ann Pharmacother. 2009;43(10):1583-97.