Frequently asked questions
- What is a generic?
- Are quality standards the same for generic and innovator (branded) drugs?
- What is the difference between an authorized generic (AG) and other generic drugs?
- What is the advantage of an authorized generic (AG)?
- How long does it take to "relaunch" an innovator drug as an authorized generic (AG)?
- What is an Abbreviated New Drug Application (ANDA) generic product?
- When were Abbreviated New Drug Application (ANDA) generics introduced in the United States?
What is a generic?
A generic drug is a medicine that is the unbranded equivalent of an innovator (branded) drug. By law, generic drugs must contain the same active ingredients as the original, although inactive ingredients (eg, colorings, flavorings, binders) may vary. Approval to market a generic drug may be requested from the US Food and Drug Administration (FDA) shortly before (or after) patent exclusivity for an innovator drug expires.1,2
Are quality standards the same for generic and innovator (branded) drugs?
Yes. The US Food and Drug Administration (FDA) maintains the same rigid standards for branded and generic products. Among other FDA approval requirements, a generic drug must: a) contain the same active ingredients as the innovator (branded) drug; b) be identical in strength, dosage form, and route of administration; and c) meet the same batch requirements for identity, strength, purity, and quality specified by the FDA's good manufacturing practices.1
What is the difference between an authorized generic (AG) and other generic drugs?
Technically, authorized generics (AGs) are marketed under the auspices of the New Drug Application (NDA) originally submitted to the US Food and Drug Administration (FDA) for the innovator brand. On a practical level, an authorized generic is the innovator drug without the brand name, which the innovator drug company (the drug's inventor) markets through a subsidiary or in partnership with another firm.3
Authorized generics contain the same active ingredients as the originals, as well as the same inactive ingredients (eg, colorings, flavorings, binders).3 Typically, the authorized generics available from Greenstone are the same sizes, shapes, colors, and dosage strengths as the originals.
What is the advantage of an authorized generic (AG)?
The American Medical Association offers detailed recommendations on refilling prescriptions with a substitute that deviates in appearance (eg, size, shape, color) from what a patient is accustomed to taking. The visual consistency typically offered by an authorized generic may help reduce patient confusion and concern, and more importantly, dosing errors.4
How long does it take to "relaunch" an innovator drug as an authorized generic (AG)?
At Greenstone, our experience is that it can take a few quarters to several years to bring a product extension of an innovator brand to market. For more information on an authorized generic partnership with Greenstone, please click here.
What is an Abbreviated New Drug Application (ANDA) generic product?
An ANDA product is a generic drug that has the same active ingredients as its corresponding innovator brand (although inactive ingredients may vary). US Food and Drug Administration (FDA) reviews of these products are abbreviated because generic drug manufacturers are generally not required to repeat the clinical research included in the original (innovator) drug application. As with any generic drug, ANDA products are subject to FDA approval requirements and quality standards. ANDA products may not infringe on patent protections for the original brand.1
When were Abbreviated New Drug Application (ANDA) generics introduced in the United States?
The driving force behind ANDA products was the Hatch-Waxman Act, formally known as The Drug Price Competition and Patent Term Restoration Act of 1984. The law modified patent protections for new drugs, and authorized the US Food and Drug Administration (FDA) to permit abbreviated new drug applications for generic versions of products losing exclusivity. By eliminating the requirement to duplicate the clinical research originally conducted on the innovator drug, the new application process removed a major economic barrier for generic drug marketers. Today, the Congressional Budget Office estimates that generic drugs save American consumers $8 billion to $10 billion annually at retail pharmacies.1
References: 1. What are generic drugs? US Food and Drug Administration Web site. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm144456.htm. Accessed April 26, 2012. 2. Reiffen D, Ward MR. “Branded generics” as a strategy to limit cannibalization of pharmaceutical markets. Federal Trade Commission Web site. http://www.ftc.gov/be/healthcare/wp/12_Reiffen_BrandedGenericsAsAStrategy.pdf. Published May 2005. Accessed May 8, 2012. 3. FDA efforts to expedite generic drug approvals. US Food and Drug Administration Web site. http://www.fda.gov/NewsEvents/Testimony/ucm161497.htm. Accessed April 26, 2012. 4. Report 2 of the Council on Science and Public Health (A-07): generic substitution of narrow therapeutic index drugs. American Medical Association Web site. http://www.ama-assn.org/resources/doc/csaph/csaph2a07-fulltext.pdf. Accessed April 26, 2012.