- FDA Listing of Authorized Generic Drugs (updated 12/30/2016)
What Is an Authorized Generic Drug?
The term “authorized generic” drug is most commonly used to describe an approved, brand name drug that is marketed as a generic product 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. It 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, the authorized generic may be sold at a lower cost than the brand name drug.
How Is an Authorized Generic Drug Different from a “Traditional” Generic Drug?
“Traditional” generic drugs are copies that one company makes of a brand-name drug that another company developed. They are the same as the brand name drug in active ingredient, dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. However, they may have certain, minor differences from brand name product, such as different inactive ingredients. To obtain approval, generic drug makers must submit an Abbreviated New Drug Application (ANDA) to FDA and prove that their product performs in the same way and is as safe and effective as the brand-name drug. The ANDA process does not require the generic drug maker to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness, and therefore, is generally less costly and burdensome than approval of an application for a brand name drug.
In contrast, brand name companies (or their licensees) may market authorized generics under the company’s originally approved New Drug Application (NDA). With the exception of not using the brand name on the label, they are the exact same drug the company already manufactures. Because authorized generics are marketed under the brand name’s NDA, they are not listed in FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book). However, as stated in the preface to the Orange Book, an authorized generic is considered to be therapeutically equivalent to its brand-name drug. This is true even if the brand-name drug is single source or coded as non-equivalent (e.g., BN) in the Orange Book. A separate application (NDA or ANDA) is not required for marketing an authorized generic, but 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.
Listing of Authorized Generic Drugs
As part of their required annual reports, NDA holders must notify the FDA of any authorized generic drugs marketed under their approved NDAs. FDA publishes a list of reported authorized generics and updates that list quarterly.
Statutory History and Legal Definition for Annual Reports
On September 27, 2007, the President signed into law the Food and Drug Administration Amendments Act (FDAAA) (Public Law 110-85). Among other things, FDAAA added new subsection (t) to section 505 of the Federal Food, Drug, and Cosmetic Act (the Act). Section 505(t) is titled “Database For Authorized Generic Drugs,” and requires that FDA publish a complete list on its Internet site of all authorized generic drugs, including (1) the drug trade name, (2) the brand company manufacturer, and (3) the date the authorized generic drug entered the market. The agency is required to update the list quarterly. Section 505(t)(2) of the Act requires the list to contain authorized generic drugs included in an annual report submitted to the agency after January 1, 1999.
Subsection 505(t)(3) defines an “authorized generic drug” as a listed drug as defined in § 314.3 that has been approved under subsection 505(c) of the act and is marketed, sold, or distributed directly or indirectly to retail class of trade with either labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trade mark that differs from that of the listed drug.
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