A generic drug duplicates a brand-name drug in dosage, safety, strength, quality and performance.
Are generic drugs as safe as brand-name drugs?
Yes. The FDA requires that all drugs be safe and effective. Additionally, the FDA requires that the generic pharmaceutical manufacturer must prove that their generic version of the product:
contains the same active ingredient
is identical in strength, dosage form and route of administration
has the same indications, dosing and labeling
is bioequivalent
meets the same batch-to-batch requirements for strength, purity and quality
is manufactured under the same strict good manufacturing practice regulations as the branded pharmaceutical.
Do generic drugs take longer to work in the body?
No. Generic drugs work in the same amount of time and in the same manner as the brand version.
If brand-name drugs and generic drugs have the same active ingredients, why do they look different?
Trademark law does not allow a generic drug to look exactly like the brand-name drug. However, a generic drug must contain the same active ingredients even though colors, flavors and certain other inactive ingredients may be different.
Why are generic drugs less expensive than brand counterparts?
Generic drugs are less expensive because their manufacturers do not have the investment costs of developing a new drug from "scratch". New drugs are developed under patent protection. The patent is designed to help promote investment in research and development, marketing and promotion - by giving the company the sole right to sell the drug while the patent is in effect. As patents near expiration, manufacturers can apply to the FDA to sell generic versions. Because generic manufacturers do not have the same development costs, they can sell their product at substantially lower costs. Today, almost half of all prescriptions are filled with generic drugs.
Where can I find additional information on generic drugs?
Your physician, pharmacist and insurance company are the best sources for information on generic drugs. There are also online resources available such as the FDA at http://www.fda.gov/cder/ogd/index.htm
