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. The FDA won't permit drugs to be made in substandard facilities. The 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.
Are generic drugs as safe as brand-name drugs?
Yes. The FDA requires that all drugs be safe and effective. Because generics contain 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.
Are generic drugs as strong as brand-name drugs?
Yes. The 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. According to the FDA, generic drugs work in the same way and in the same amount of time as brand-name drugs.
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.
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.
What are generic drugs?
A generic drug is a copy of a brand-name pharmaceutical that contains the same active ingredient and is equivalent in dosage, safety, strength, how it is taken, quality, performance and intended use.
What is an ANDA?
An Abbreviated New Drug Application (ANDA) contains data that provides for the review and approval of a generic drug product by the FDA. In the application, generic manufacturers must scientifically prove that their products are bioequivalent to the brand products.
What is bioequivalence?
It is an FDA requirement that the active ingredient of a generic drug be absorbed into the body and metabolized in approximately the same amount over approximately the same period as the active ingredient of the innovator drug. Bioequivalence is demonstrated in two ways. Dissolution testing determines if the generic drug product dissolves in approximately the same amount of time as the innovator product. Blood-level testing is done by giving the generic drug product to humans and measuring how much of the drug enters the bloodstream, how fast it does so, and how long it takes to leave the body.
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 visit the FDA website
for more information.
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, more than half of all prescriptions are filled with generic drugs.