Authorized Generic Drug l Marketing Authorization l FDA's list of Authorized Generic Drugs

           

Authorized Generic Drug

The term “authorized generic” drug is most commonly used to describe an approved brand name drug that is marketed without the brand name on its label. Other than the fact that it does not have the brand name on its label, it is the exact same drug product as the branded product. An authorized generic may be marketed by the brand name drug company, or another company with the brand company’s permission. In some cases, even though it is the same as the brand name product, a company may choose to sell the authorized generic at a lower cost than the brand name drug.

                            

Marketing Authorization - Authorized Generic Drugs

An authorized generic drug is the same as the brand-name drug but does not use the brand name on the label. In addition, an authorized generic version of a tablet or capsule may have a different color or marking. Because an authorized generic drug is marketed under the brand name drug’s New Drug Application (NDA), it is not listed in FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book). 

An authorized generic is considered to be therapeutically equivalent to its brand-name drug because it is the same drug. This is true even if the brand-name drug is “single source,” meaning there are no ANDAs approved for that product, or coded as non-equivalent (e.g., BN) by FDA in the Orange Book. While a separate NDA is not required for marketing an authorized generic, FDA requires that the NDA holder notify the FDA if it markets an authorized generic. The NDA holder may market both the authorized generic and the brand-name product at the same time.

 

How to get the list of Authorized Generic Drugs

This list of authorized generic drugs (AGs) was created from a manual review of FDA’s database of annual reports submitted to the FDA since January 1, 1999 by sponsors of new drug applications (NDAs).

Currently, FDA’s List of Authorized Generics as of December 28, 2020 is available. To get the list follow the link   https://www.fda.gov/media/77725/download