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Facts About Generic Drugs Infographic PDF

Generic drugs make up nearly 8 in 10 prescriptions filled in the U.S. Generic drugs must have the same active ingredients, strength, dosage form, and route of administration as the brand name drug. The generic manufacturer must prove its drug is bioequivalent to the brand name drug through testing. On average, generic drugs cost 80-85% less than their brand name counterparts, saving $158 billion in 2010 alone. While lower in price, generic drugs do not mean inferior quality as they must meet the same standards as brand name drugs. The FDA monitors generic drugs for safety and adverse events.

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402 views3 pages

Facts About Generic Drugs Infographic PDF

Generic drugs make up nearly 8 in 10 prescriptions filled in the U.S. Generic drugs must have the same active ingredients, strength, dosage form, and route of administration as the brand name drug. The generic manufacturer must prove its drug is bioequivalent to the brand name drug through testing. On average, generic drugs cost 80-85% less than their brand name counterparts, saving $158 billion in 2010 alone. While lower in price, generic drugs do not mean inferior quality as they must meet the same standards as brand name drugs. The FDA monitors generic drugs for safety and adverse events.

Uploaded by

bimu
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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FACTS ABOUT

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

SAME QUALITY &


GENERIC BRAND
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.
ALL FDA-APPROVED GENERIC DRUGS
MUST BE EQUIVALENT TO THE BRAND-NAME DRUG.
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.

80-85% LESS
Average cost of a generic drug
vs. its brand-name counterpart
$$$ $

$$$
In 2010 alone, the use of FDA-approved
generics saved $158 billion.
$
$3 billion saved every week!
Sun Mon Tues Wed Thurs Fri Sat
THE LOWER PRICE
DOESN’T MEAN INFERIOR.
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.

FDA MONITORS ADVERSE EVENTS


REPORTS FOR GENERIC DRUGS.
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.

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.

Davit et al. Comparing generic and innovator drugs:


1

a review of 12 years of bioequivalence data from the United States Food and Drug Administration.
Ann Pharmacother. 2009;43(10):1583-97.

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