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Source: FDA.gov / CDER (Center for Drug Evaluation and Research)
The FDA is a U.S. Government agency which regulates the production of
food, drugs and cosmetics and protects the consumer from unsafe
products.
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.
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.
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 drugs made in more modern facilities?
No.
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 and generic drugs 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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