Helpful information about generic medicines

Frequently asked questions

What is a brand name drug?
A brand name drug is a drug marketed under a proprietary, trademark-protected name.1 It is often protected with a patent from being manufactured by other companies.2 Generally speaking, when the drug loses exclusivity, other companies may market a generic version.2

What is a generic drug?
A generic drug is bioequivalent to the brand name drug.3 The active ingredients, dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use must be the same.3

One route to marketing a generic drug is to get FDA approval by filing an Abbreviated New Drug Application (ANDA) containing a study that proves bioequivalence to the already approved brand name drug. The manufacturer is not required to generate clinical trial data for safety and effectiveness, and use those from the original New Drug Application (NDA),3 so the path to approval may not be as long or as costly. An NDA is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States.4 This is one of the reasons why generic drugs may be sold for less than the brand name drugs.3

Are quality standards the same for generic and brand name drugs?
Yes. In addition to being required to be bioequivalent to the brand name drug, generic drug manufacturers are held to the same strict standards of the FDA’s good manufacturing practice regulations as are brand name drug manufacturers. Generic drug manufacturers must meet the same batch requirements for identity, strength, purity, and quality, as well as contain the same active ingredients and be identical in strength, dosage form, and route of administration as the brand name drug.3

How do generic drugs differ from the brand name drug?
While a generic drug must contain the same active ingredients as the brand name drug, the inactive ingredients may vary among the brand name drug and generic drugs.3 This means that most generics are a different size, shape, color, and/or flavor than the brand name drug.

Generic drugs must be bioequivalent to the brand name drug. Bioequivalence refers to the equivalent release of the same drug substance from 2 or more drug products or formulations. If a drug product contains a drug substance that is chemically identical and is delivered to the site of action at the same rate and extent as another drug product, it is equivalent and can be substituted for that drug product.5

What is an authorized generic?
Authorized generics contain the same active ingredients and are identical to the brand name drug in strength, dosage form, and route of administration.3 They also have the same inactive ingredients and are typically the same size, shape, and color as the brand name drug. The differences are typically characteristics such as the markings on the tablets, labeling, and packaging.6

Why use an authorized generic from GREENSTONE?
GREENSTONE authorized generics, like all authorized generics, are manufactured under the NDA of the brand name drug, not under an ANDA for the secondary approval like most generic drugs. They contain the same active3 and inactive ingredients, and have the same safety profiles as the brand name drugs. GREENSTONE authorized generic tablets and capsules are identical to the brand name drug in look and feel, except for minor changes like the imprint or embossing on the product.

GREENSTONE is committed to delivering trust, partnership, and a consistent supply of the authorized generics you need, backed by a dedication to excellence in customer service. GREENSTONE authorized generics and ANDA products are readily available at many pharmacies in the United States.

Additional information about generic drugs is available from the FDA at:
Listing of authorized generics
Understanding generic drugs

These websites are neither owned nor controlled by GREENSTONE. GREENSTONE does not endorse and is not responsible for the content or services of these sites.


References: 1. US Food and Drug Administration. Drugs@FDA Glossary of Terms. February 2012. http://www.fda.gov/drugs/
informationondrugs/ucm079436.htm
. Accessed March 24, 2014. 2. US Food and Drug Administration. Facts about generic drugs.
http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/UCM219406.pdf.
Accessed March 24, 2014. 3. US Food and Drug Administration. Generic drugs: questions and answers. Drugs. September 3,
2013. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm. Accessed March 24, 2014. 4. US
Food and Drug Administration. Drugs: New Drug Application (NDA). Drugs. February 21, 2013. http://www.fda.gov/Drugs
/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm
. Accessed
April 2, 2013. 5. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,
Office of Pharmaceutical Science, Office of Generic Drugs. Approved Drug Products With Therapeutic Equivalence Evaluations. 34th ed.
2014. 6. US Food and Drug Administration. List of Authorized Generic Drugs. http://www.fda.gov/Drugs/DevelopmentApprovalProcess
/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm126389.htm
. Accessed
March 24, 2014.

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Visit www.fda.gov/medwatch or call 1-800-FDA-1088.