US Pharm. 2020;45(6):23.

ABSTRACT: As you fill prescriptions with generic medications, it’s important to know that there’s a category of generic drugs—Authorized Generics—that you may not be familiar with.

What Are Authorized Generics and How Are They Different From Other Generics?

Authorized Generics are a category of generic drugs made by the manufacturer of the brand name drug. They are the same as the brand name drug but do not use the brand name on the label and may have a different color or marking.1

An Authorized Generic is marketed under the brand name drug’s New Drug Application (NDA) and is therefore not listed in the Food and Drug Administration’s (FDA) Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book). The FDA does require that the NDA holder notify the FDA if it markets an Authorized Generic. Generic drugs are approved via submission of an Abbreviated New Drug Application (ANDA) to the FDA to prove that the product is the same as the brand name drug, and that it is bioequivalent. As part of the ANDA process, a generic drug must meet the same standards of quality and manufacturing as the brand name drug but is not required to provide independent evidence of the safety and effectiveness of a proposed generic drug, instead relying on the FDA’s finding that a previously approved drug product is safe and effective.1

All generics work in the same way and provide the same clinical benefit as the brand name version, but unlike other generics, Authorized Generics are generally made in the same manufacturing facility as the brand name drug. Further, Authorized Generics are the same size and shape as the brand name version and may have a different marking or, in limited circumstances, a different color. In contrast, generic medications may differ in appearance from the brand name drug, often varying in size, shape, and/or color. Additionally, generics may have other minor differences from the brand such as inactive ingredients, which while usually harmless, in some cases, may not be well tolerated in certain patients.1-3

Although many people may not be familiar with Authorized Generics, they are not new. For example, Greenstone LLC, a US-based company owned by Pfizer Inc., has been providing Authorized Generic versions of original brand name medications for more than 25 years. Greenstone sells over 70 of Pfizer’s brand name drugs as Authorized Generics that are prescribed to treat a range of therapeutic areas. Greenstone also provides a limited number of Authorized Generics and generics from other manufacturers. More information is available at GreenstoneLLC.com.

“Pharmacists can be instrumental in educating patients about their medication choices, including about the availability of generic medications and Authorized Generics as a specific category of generic medications,” says Justine Alderfer, Pharm.D., a Pfizer Medical Affairs Director for Greenstone.

Preserving patient, physician, and pharmacist medication choice may be a critical component to making healthcare accessible.

A list of Authorized Generics can be found on the FDA website.


REFERENCES:

1. US Food and Drug Administration. FDA List of Authorized Generic Drugs. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm126389.htm. Accessed April 15, 2020.
2. US Food and Drug Administration. Generic drugs: Questions and Answers. https://www.fda.gov/drugs/questions-answers/generic-drugs-questions-answers. Accessed February 18, 2020.
3. Smith Marsh DE. Bioequivalence and Interchangeability of Generic Drugs. Merck Manual. https://www.merckmanuals.com/home/drugs/brand-name-and-generic-drugs/bioequivalence-and-interchangeability-of-generic-drugs. Accessed February 18, 2020.