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About Generic Drugs
1. 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.
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2. Are generic drugs as safe as
brand-name drugs?
Yes. FDA requires that all drugs be
safe and effective. Since generics use the same active
ingredients and are shown to work the same way in the
body, they have the same risks and benefits as their
brand-name counterparts.
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3. 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.
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4. 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.
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5. 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.
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6. 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.
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7. If brand-name drugs and generic
drugs have the same active ingredients, why do they look
different?
In the United States, trademark laws
do not allow a generic drug to look exactly like the
brand-name drug. However, a generic drug must duplicate
the active ingredient. Colors, flavors, and certain
other inactive ingredients may be different.
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8. Does every brand-name drug have
a generic counterpart?
No. Brand-name drugs are generally
given patent protection for 20 years from the date of
submission of the patent. This provides protection for
the innovator who laid out 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.
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9. What is the best source of
information about generic drugs?
Contact your physician, pharmacist, or
insurance company for information on your generic drugs.
You can also visit the FDA website at
http://www.fda.gov/cder/ogd/index.htm for more
information.
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