FAQs
1. What are generic drugs? 2. Are generic drugs as safe as brand-name drugs? 3. Are generic drugs as strong as brand-name drugs? 4. Can I request a generic drug? 5. Why are generic drugs less expensive? 6. If brand-name and generic drugs have the same active ingredients, why do they look different? 7. Why does it take so long for a generic drug to become available? 8. Does every brand-name drug have a generic counterpart? 9. Who manufactures generic drug products? 10. How are generic drugs approved for use?
1. What are generic drugs? When a brand-name drug's patent protection expires, generic versions of the drug can be approved for sale. A new drug is given two names: (1) a generic name, also known as a chemical name describing its chemical makeup, and (2) a brand name, which is what the manufacturer calls the product in advertisements.
2. Are generic drugs as safe as brand-name drugs? Yes. The U.S. Food and Drug Administration (FDA) requires that all drugs be safe and effective, whether they are generic or brand-name products.
3. 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. The FDA also requires the active ingredient in the generic drug be released and absorbed at about the same rate as in the brand-name drug.
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4. Can I request a generic drug? Absolutely. When your provider prescribes a drug, ask if a generic is available and appropriate for you.
5. Why are generic drugs less expensive? Generic manufacturers can sell their product at substantial discounts because they don't have to repeat all the clinical tests conducted for brand-name drugs. Plus, competition among generic manufacturers helps keep the price down.
6. If brand-name and generic drugs have the same active ingredients, why do they look different? U.S. trademark laws don't allow generic drugs to look exactly like other drugs already on the market. However, they must duplicate the active ingredient. Colors, shapes, flavors and certain other inactive ingredients may vary.
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7. Why does it take so long for a generic drug to become available? Manufacturers of brand-name drugs usually receive patent protection after spending the time and money to research and develop a drug. That protection prevents other companies from making and selling their own version of the drug until the patent expires. Most drug patents are protected for 20 years from the patent's submission date. After a patent expires, other companies can create and market their own version of a drug, once they receive FDA approval.
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. If a drug's patent hasn't expired, other drug companies cannot introduce competitive generic versions.
9. Who manufactures generic drug products? In some instances, the same drug companies that manufacture brand-name products also manufacture the generic versions and sell them to other generic manufacturers. According to the FDA, brand-name manufacturers are responsible for producing 50 percent of generic drugs.
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10. How are generic drugs approved for use? The FDA reviews all brand-name and generic products for safety and effectiveness. Before a generic drug is approved for use in the U.S., its manufacturer must provide the FDA with proof that the product has the identical active ingredient when compared to the brand-name product. The generic product also must meet the FDA's standards for the amount of active ingredient and speed of absorption into the body. When these standards are met, the drug is considered equivalent. The FDA also conducts periodic inspections of the manufacturing plant and monitors drug quality, once the drug is approved.
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