Authorized Generic

Key facts

Marketed under

The brand's approved New Drug Application, not an ANDA

Public list

FDA publishes a list compiled from NDA holder annual reports

NDC Directory marketing category

NDA AUTHORIZED GENERIC

Separate FDA approval needed

No; it relies on the existing brand approval

What is an authorized generic?

An authorized generic is made under the brand's approved application, so its active ingredient, formulation and dosage form match the brand-name drug. It is sold under the nonproprietary name and priced to compete with independent generics.

The brand company may sell it through a subsidiary or license it to a generic manufacturer. Because no Abbreviated New Drug Application (ANDA) is involved, an authorized generic needs no bioequivalence studies or new FDA approval, and the New Drug Application (NDA) holder decides when it launches.

How brand companies use authorized generics

Authorized generics usually appear around loss of exclusivity:

• During the 180-day exclusivity period of the first Paragraph IV generic filer, which blocks other ANDA generics but not an authorized generic.
• As a bargaining term in patent litigation settlements, where a brand may agree to delay or forgo its own authorized generic.
• To keep part of the volume and revenue after generic entry instead of ceding the whole market to independent generics.
• Occasionally before any generic launches, to preempt competition or answer payer pressure on list prices.

Why authorized generics matter

A 2011 Federal Trade Commission study found that authorized generic competition during the 180-day period lowered generic prices and substantially reduced the first filer's revenue, which is why launch timing is watched closely.

• Competitor counts: counting ANDA holders alone undercounts generic competition; the NDC Directory marketing category NDA AUTHORIZED GENERIC fills the gap.
• Medicaid rebates: because it is marketed under an NDA, an authorized generic is generally treated as an innovator drug in the Medicaid Drug Rebate Program, with a higher statutory rebate than ANDA generics.
• Labeler mapping: the labeler on an authorized generic NDC may be a generic company even though the application holder is the brand company.
• Price analysis: NADAC and other pricing files may classify the product differently from its application type, so check both before grouping brand and generic rows.