Facts about Generic Drugs
You have probably heard of generic drugs and wondered whether or not you should take them. Before deciding, you should know:
What is the Background of a Drug?
How are Generic Drugs Approved?
What are the Manufacturing Standards for Generic Drugs?
Does a Generic Drug Look the Same as its Branded Equivalent?
Why Choose Generic Drugs?
Additional Information
- What is the Background of a Drug?
The life cycle of a drug begins when a brand-name manufacturer submits a patent for an Active Pharmaceutical Ingredient (API) which has a life of 20 years. From the API, the manufacturer then develops a New Drug Application (NDA) which is submitted to the Food and Drug Administration (FDA). The NDA presents clinical trials to determine safety, efficacy and effective dose, and adverse reactions. Should FDA find the drug safe and effective for its intended use, the manufacturer is awarded final approval and the drug is marketed.
The manufacturer then conducts post-marketing surveillance to accumulate information addressing the occurrence and frequency of any new or known adverse reactions to the drug product. This information is reported to FDA who then shares it with healthcare professionals.
- How are Generic Drugs Approved?
Upon expiration of the brand-name product's patent protection, generic pharmaceutical manufacturers may be approved to market generic versions of the drug product. The generic product must use the identical API and show bioequivalence (the drug must work the same as the brand-name product).
Upon approval by FDA and the expiration of the patent of the brand-name product, the generic drug may then be marketed.
- What are the Manufacturing Standards for Generic Drugs?
Generic drugs are manufactured in modern facilities that are required to meet the same FDA standards of good manufacturing practices as brand-name products. Manufacturing facilities are inspected by FDA to ensure these practices are followed.
FDA will not allow a drug to be manufactured in facilities that do not meet these standards.
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- Does a Generic Drug Look the Same as its Branded Equivalent?
The appearance of a brand-name drug is trademarked, so the generic product cannot look exactly like the brand. Differences may include shape, color, flavor, and some other inactive ingredients. The active ingredients must be identical.
- Why Choose Generic Drugs?
Generic drugs are lower in cost than comparable brand-name products, saving consumers money and making drugs accessible to those who might otherwise be unable to afford them.
Healthcare providers and consumers can be assured that approved generic drugs meet the same rigid standards as their brand-name counterparts. Since the time to develop a generic drug is shorter, and clinical trials were already conducted, the cost is less than the brand-name product. Therefore, generic manufacturers typically sell their generic drugs at a lower price. This cost benefit is passed on to consumers.
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Additional Information
For more information on generic drugs, please visit the following links:
U.S. Food and Drug Administration, Center for Drug Evaluation & Research, Office of Generic Drugs
http://www.fda.gov/cder/ogdGeneric Pharmaceutical Association
http://www.gphaonline.org/7957