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DeliverinG Answers

Frequently asked questions about generic medicines

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 the same as a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.3

To gain FDA approval, a generic drug must meet certain FDA requirements, including containing the same active ingredients as the innovator (brand-name) drug (inactive ingredients may vary); having the same conditions of use, dosage form, strength, route of administration, and (with certain permissible differences) labeling; and meeting the same manufacturing and quality requirements as the brand-name drug.4

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, meaning it gets to the part of the body where the drug works at the same time and in the same amount.3,4

ANDA generic drugs must contain the same active ingredients as the brand-name drug and must be identical in strength, dosage form, and route of administration.3 However, their inactive ingredients may vary.3 Some generics may also be a different size, shape, color, and/or flavor than the brand-name drug.3,5

Alternatively, an “authorized generic drug” (described in greater detail below) is marketed under a brand-name drug’s NDA and is the exact same drug as the branded drug. An authorized generic may be marketed by the brand-name drug company or by another company with the brand-name drug company’s permission.4

Since generic drug makers can rely on the innovator’s evidence of safety and effectiveness, it is generally less costly to obtain approval of a generic drug than a brand-name drug. Therefore, generic drugs are usually less expensive than brand-name drugs.3

What is an authorized generic?

According to the FDA, an authorized generic drug is the exact same as a brand-name drug. The only difference is that authorized generics do not include the brand name on their labels.4As opposed to a generic drug, which may have certain differences from the brand-name product, like inactive ingredients, an authorized generic drug is identical in both active and inactive ingredients to a brand-name drug.4

An authorized generic may be marketed by the original brand-name drug company or it may provide another company permission to do so.4 In some cases, a company may choose to sell the authorized generic at a lower cost than its brand-name drug even though it is the same drug.4

An authorized generic is marketed under the brand-name drug’s NDA. It is considered to be therapeutically equivalent to the brand-name drug because it is the same drug.4 This means it has the same clinical efficacy and safety profile.6

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
  • Size
  • Shape
  • Strength

GREENSTONE authorized generic drugs are identical to the brand-name drug, except for minor differences in their appearance like markings on the product, coloring, 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. New drug application (NDA). http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm. Accessed November 29, 2017.
2. National Heart, Lung, and Blood Institute. What are clinical trials? http://www.nhlbi.nih.gov/studies/clinicaltrials. Accessed November 29, 2017.
3. US Food and Drug Administration. Generic drugs: Questions and answers. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm. Accessed November 29, 2017.
4. US Food and Drug Administration. FDA list of authorized generic drugs. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm126389.htm. Accessed November 29, 2017.
5. US Food and Drug Administration. Size, shape, and other physical attributes of generic tablets and capsules: guidance for industry. https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm377938.pdf. Published June 2015. Accessed November 29, 2017.
6. US Food and Drug Administration. Approved drug products with therapeutic equivalence evaluations. 37th edition. https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/UCM071436.pdf Accessed November 29, 2017.