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Generic Drugs

Generic Drugs Approximately 85% of all prescriptions filled in the United States are for generic drugs. What Are Generic Drugs? Once a new drug is approved, the pharmaceutical company receives an exclusive right to market that drug for a guaranteed minimum of 5 to 7 years. Most new drugs are also protected by patents that last 20 years from the first discovery of the molecule before its clinical testing. Altogether, new drugs receive about 12 to 14 years of market exclusivity. Market exclusivity periods allow companies to get a return on their investment into development of that drug and to make a profit. When the market exclusivity period is over, other companies can apply for approval of their versions of the product containing the same active ingredient. The active ingredient is the chemical substance that carries the effect of the medication. Generic drugs can be much cheaper than brand-name drugs because they create competition in the marketplace, and generic companies do not need to account for as high of development costs. Effectiveness of Generic Drugs Generic drugs are identical to their brand-name comparison drugs in terms of active ingredients, but their inactive ingredients can vary. Inactive ingredients do not affect the chemical activity of a drug and are added during manufacturing for stability and preservation purposes or to achieve a certain consistency, form, color, or taste. Generic drugs are approved by the US Food and Drug Administration based on testing demonstrating the drugs’ safety, purity, and effectiveness. This means that a generic drug is interchangeable with a brand-name drug. A study that compared a group of generic heart medications with their brand-name counterparts found no evidence that brand-name drugs were superior to generic drugs. Advantages and Disadvantages The most significant advantage of using generic drugs is the cost, which can be up to 85% less than that of a brand-name drug. Lower-cost generic drugs have been shown to increase the likelihood that patients take essential medications prescribed by their doctors and to improve patients’ health outcomes. If you are using a brand-name drug, ask your doctor whether a generic form of that same medication—or a generic form of another medication in the same class—is available. A disadvantage of generic drugs is that their appearance may change if the manufacturer supplying your pharmacy changes, although variations in appearance should not affect the effectiveness or safety of the drug. Some people report new or different symptoms when they switch from a brand-name drug to a generic form or from a generic drug to another generic drug. Although such experiences may not be related to the generic drug, you should consult with your doctor to discuss any symptoms. Box Section Ref ID For More Information US Food and Drug Administration www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm To find this and previous JAMA Patient Pages, go to the Patient Page link on JAMA’s website at www.jama.com. Spanish translations are available in the supplemental content tab. The JAMA Patient Page is a public service of JAMA. The information and recommendations appearing on this page are appropriate in most instances, but they are not a substitute for medical diagnosis. For specific information concerning your personal medical condition, JAMA suggests that you consult your physician. This page may be photocopied noncommercially by physicians and other health care professionals to share with patients. To purchase bulk reprints, call 312/464-0776. Back to top Article Information Sources: Kesselheim AS, Misono AS, Lee JL, et al. Clinical equivalence of generic and brand name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA. 2008;300(21):2514-2526. Gagne JJ, Choudhry NK, Kesselheim AS, et al. Comparative effectiveness of generic and brand-name statins on patient outcomes. Ann Intern Med. 2014;161:400-407. Topic: Medications http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Generic Drugs

Razmaria, Aria A.
JAMA , Volume 315 (24) – Jun 28, 2016
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Generic Drugs

Abstract

Approximately 85% of all prescriptions filled in the United States are for generic drugs. What Are Generic Drugs? Once a new drug is approved, the pharmaceutical company receives an exclusive right to market that drug for a guaranteed minimum of 5 to 7 years. Most new drugs are also protected by patents that last 20 years from the first discovery of the molecule before its clinical testing. Altogether, new drugs receive about 12 to 14 years of market exclusivity. Market exclusivity periods...
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Publisher
American Medical Association
Copyright
Copyright © 2016 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2016.3990
Publisher site
See Article on Publisher Site

Abstract

Approximately 85% of all prescriptions filled in the United States are for generic drugs. What Are Generic Drugs? Once a new drug is approved, the pharmaceutical company receives an exclusive right to market that drug for a guaranteed minimum of 5 to 7 years. Most new drugs are also protected by patents that last 20 years from the first discovery of the molecule before its clinical testing. Altogether, new drugs receive about 12 to 14 years of market exclusivity. Market exclusivity periods allow companies to get a return on their investment into development of that drug and to make a profit. When the market exclusivity period is over, other companies can apply for approval of their versions of the product containing the same active ingredient. The active ingredient is the chemical substance that carries the effect of the medication. Generic drugs can be much cheaper than brand-name drugs because they create competition in the marketplace, and generic companies do not need to account for as high of development costs. Effectiveness of Generic Drugs Generic drugs are identical to their brand-name comparison drugs in terms of active ingredients, but their inactive ingredients can vary. Inactive ingredients do not affect the chemical activity of a drug and are added during manufacturing for stability and preservation purposes or to achieve a certain consistency, form, color, or taste. Generic drugs are approved by the US Food and Drug Administration based on testing demonstrating the drugs’ safety, purity, and effectiveness. This means that a generic drug is interchangeable with a brand-name drug. A study that compared a group of generic heart medications with their brand-name counterparts found no evidence that brand-name drugs were superior to generic drugs. Advantages and Disadvantages The most significant advantage of using generic drugs is the cost, which can be up to 85% less than that of a brand-name drug. Lower-cost generic drugs have been shown to increase the likelihood that patients take essential medications prescribed by their doctors and to improve patients’ health outcomes. If you are using a brand-name drug, ask your doctor whether a generic form of that same medication—or a generic form of another medication in the same class—is available. A disadvantage of generic drugs is that their appearance may change if the manufacturer supplying your pharmacy changes, although variations in appearance should not affect the effectiveness or safety of the drug. Some people report new or different symptoms when they switch from a brand-name drug to a generic form or from a generic drug to another generic drug. Although such experiences may not be related to the generic drug, you should consult with your doctor to discuss any symptoms. Box Section Ref ID For More Information US Food and Drug Administration www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm To find this and previous JAMA Patient Pages, go to the Patient Page link on JAMA’s website at www.jama.com. Spanish translations are available in the supplemental content tab. The JAMA Patient Page is a public service of JAMA. The information and recommendations appearing on this page are appropriate in most instances, but they are not a substitute for medical diagnosis. For specific information concerning your personal medical condition, JAMA suggests that you consult your physician. This page may be photocopied noncommercially by physicians and other health care professionals to share with patients. To purchase bulk reprints, call 312/464-0776. Back to top Article Information Sources: Kesselheim AS, Misono AS, Lee JL, et al. Clinical equivalence of generic and brand name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA. 2008;300(21):2514-2526. Gagne JJ, Choudhry NK, Kesselheim AS, et al. Comparative effectiveness of generic and brand-name statins on patient outcomes. Ann Intern Med. 2014;161:400-407. Topic: Medications

Journal

JAMA – American Medical Association

Published: Jun 28, 2016

Keywords: generic drugs,pharmaceutical economics

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