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Generic and Brand Name Drugs
by Youmasu J. Siewe, Ph.D, MPH.
We have all used drugs or medications at some time
in our lives. Some of us must use them on a daily basis to stay alive.
Some drugs are must be prescribed by healthcare providers, while others
can be purchased over the counter. In a question and answer format, this
article will highlight on the therapeutic or legally intended use of
drugs.
A drug must be investigated or tested and retested
before marketed, and retains three different names in the process: 1). the
chemical name; 2) the generic or nonproprietary name and 3) the trade,
brand or proprietary name. Chemical names of drugs represent the exact
description of the drug’s chemical composition. These names are usually
meaningful only to the Chemist, and of little importance to the regular
consumer. A generic name of a drug is assigned by the manufacturer with
the US Adopted Name (USAN) council of the USP. Generic names are simpler
than chemical names and derived from the chemical name itself. Trade or
brand names of drugs are copyrighted and given by the company selling the
drug. This means other companies can not sell a copyrighted drug by that
name. Trade or brand names are usually proper nouns with capitalized first
letters.
What is a drug? A drug (medication) is defined as
any substance, except food that alters one of more body functions, such as
digestive, circulatory, neurological, and other body functions. A drug
passes through rigorous investigational stages to be accepted and marketed
in the United States.
- What are generic drugs? A generic drug is a copy
that is the same as a brand-name drug in dosage, safety, strength, how
it is taken, quality, performance and intended use.
- Are generic drugs as safe as brand-name drugs?
Yes. The US Food and Drug Administration (FDA) require that all drugs be
safe and effective. Manufacturers of generic drugs are required to use
the same active ingredients (the part of the drug that does the job);
this makes the generic name drug to work the same way in the body. They
also have the same risks and benefits as their brand-name counterparts.
- Are generic drugs as strong as brand-name drugs?
Yes. FDA requires generic drugs to have the same quality, strength,
purity and stability as brand-name drugs.
- Do generic drugs take longer to work in the body?
No. Generic drugs work in the same way and in the same amount of time as
brand-name drugs.
- Why are generic drugs less expensive? Generic
drugs are less expensive because generic manufacturers don’t have the
investment costs of the developer of a new drug. New drugs are developed
under patent protection. The patent protects the investment-including
research, development, marketing, and promotion-by giving the company
the sole right to sell the drug while it is in effect. As patents near
expiration, manufacturers can apply to the FDA to sell generic versions.
Because those manufacturers don’t have the same development costs, they
can sell their product at substantial discounts. Also, once generic
drugs are approved, there is greater competition, which keeps the price
down. Today, almost half of all prescriptions are filled with generic
drugs.
- Are brand-name drugs made in more modern facilities than
generic drugs? No. Both brand-name and generic drug facilities must meet
the same standards of good manufacturing practices. FDA won’t permit
drugs to be made in substandard facilities. FDA conducts about 3,500
inspections a year to ensure standards are met. Generic firms have
facilities comparable to those of brand-name firms. In fact, brand-name
firms are linked to an estimated 50 percent of generic drug production.
They frequently make copies of their own or other brand-name drugs but
sell them without the brand name.
- Why do brand-name drugs and generic drugs look different if they have
the same active ingredients? Trademark laws in America do not allow a
generic drug to look exactly like the brand-name drug. However, a
generic drug must have the same active ingredient. Colors, flavors, and
certain other inactive ingredients may be different.
- Does every brand-name drug have a generic
counterpart? No. Brand-name drugs are generally given patent protection
for several years from the date of submission of the patent. This
provides protection for the innovator who made the initial costs
(including research, development, and marketing expenses) to develop the
new drug. However, when the patent expires, other drug companies can
introduce competitive generic versions, but only after they have been
thoroughly tested by the manufacturer and approved by the FDA.
- How else can one get information about generic
drugs? Contact your physician, pharmacist, nurse or insurance company
for information on your generic drugs.
Youmasu J. Siewe, Ph.D., MPH, is State Specialist
for Public Health Education, Oklahoma Cooperative Extension Service at OSU
in Stillwater.
For Questions, call (405) 744 6825.
For online access to
Extension/Community Health Column, please check “articles” on the web at:
http://www.fcs.okstate.edu/health/. |