Frequently asked questions about generic medicines
- What is a brand-name drug?
- What is a generic drug?
- How do generic drugs differ from the brand-name drug?
- What is an authorized generic?
- What is an authorized generic from GREENSTONE?
- Why choose GREENSTONE?
What is a brand-name drug?
A brand-name drug:
- is submitted to the Food and Drug Administration (FDA) under a New Drug Application (NDA). An NDA is a submission that officially requests the approval of a new drug by the FDA1
- is supported by clinical trial data. Clinical trials are studies that explore whether a drug is safe and effective1,2
- may have some form of exclusivity. Exclusivity protects the drug from being sold by other companies for a certain amount of time.3 When a brand-name drug loses exclusivity, pharmaceutical companies may sell an FDA approved generic version3
What is a generic drug?
A generic drug is identical—or bioequivalent—to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.4
To gain FDA approval, a generic drug must4:
- contain the same active ingredients as the innovator drug (inactive ingredients may vary)
- be identical in strength, dosage form, and route of administration
- have the same use indications
- be bioequivalent
- meet the same batch requirements for identity, strength, purity, and quality
- be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products
How do generic drugs differ from the brand-name drug?
There are generic drugs approved by the FDA under an Abbreviated New Drug Application (ANDA). An ANDA is a submission that officially requests the approval of a generic drug by the FDA.4 An ANDA must prove that the generic drug is bioequivalent to the brand-name drug.4
ANDA generic drugs must contain the same active ingredients as the brand-name drug, and have to be identical in strength, dosage form and route of administration.4 However their inactive ingredients may vary.4 Some generics may also be a different size, shape, color, and/or flavor than the brand-name drug.3
Creating a drug costs lots of money. Since generic drug makers do not develop a drug from scratch, the costs to bring the drug to market are less; therefore, generic drugs are usually less expensive than brand-name drugs.4 But generic drug makers must show to the FDA that their product performs in the same way as the brand-name drug.4
What is an authorized generic?
An authorized generic drug is identical to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.4
In general, an authorized generic is made and sold under an NDA. It has the same efficacy and safety profiles, and contains the same active ingredients and inactive ingredients as the brand-name drug. An authorized generic and the brand-name drug both are identical in strength, dosage form and route of administration. They act the same way in the body as the brand-name drug.1 The differences between authorized generics and brand-name drugs are typically characteristics such as markings on the tablets, labeling, and packaging.5
What is an authorized generic from GREENSTONE?
GREENSTONE authorized generics not only have the same efficacy and safety profiles as the brand-name drugs, but are also the same in
- Active ingredients
- Inactive ingredients
- Route of administration
- Dosage form
GREENSTONE authorized generic tablets and capsules are identical to the brand-name drug in their appearance, except for minor changes like markings on the product, labeling, and packaging.
Why choose GREENSTONE?
For more than 20 years, GREENSTONE has been committed to quality, value, and excellence in everything we do—from the standards of our generics to our dedication to reliable customer service—with the goal of helping patients live healthier lives.
GREENSTONE authorized generics are readily available at many pharmacies in the United States. Talk to your pharmacist to learn more about GREENSTONE authorized generics.
References: 1. US Food and Drug Administration. Drugs: New Drug Application (NDA). Drugs. Updated March 29, 2016. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm. Accessed May 6, 2016.
2. National Heart, Lung, and Blood Institute. What Are Clinical Trials? Clinical Trials. http://www.nhlbi.nih.gov/studies/clinicaltrials/. Accessed May 6, 2016.
3. US Food and Drug Administration. Facts About Generic Drugs. http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/UCM219406.pdf. Accessed May 6, 2016.
4. US Food and Drug Administration. Generic Drugs: Questions and Answers. Drugs. Updated January 7, 2015. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm. Accessed May 6, 2016.
5. US Food and Drug Administration. FDA List of Authorized Generic Drugs. Drugs. Updated April 1, 2016. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm126389.htm. Accessed May 6, 2016.