Authorized generics are the brand drug under a generic label

In August 2011 the Federal Trade Commission voted 5-0 to release a report on a kind of competition most patients never notice. When a brand company sold its own drug under a generic label during the first generic's 180-day head start, the FTC found, retail prices ran 4 to 8 percent lower and wholesale prices 7 to 14 percent lower¹ than when the first generic had the market to itself.

That unbranded brand product is called an authorized generic. FDA describes it as "the same as the brand-name drug"³ but without the brand name on the label. It may be sold by the brand company itself or by another company with the brand's permission.

Authorized generics matter for two reasons. A patient handed one is getting the brand's exact formulation at a generic price. And for the generic industry, an authorized generic can roughly halve the reward for being first to challenge a patent, which makes a brand's promise not to launch one a bargaining chip in patent settlements.

How they differ from ANDA generics

A traditional generic is made by a different company and approved through an abbreviated new drug application⁴ (ANDA). The applicant must show its product matches the brand in active ingredient, strength, dosage form and route, and that it is bioequivalent, the subject of GxRadar's explainer on the 80-125 rule. It does not repeat the brand's clinical trials, and FDA notes it may use different inactive ingredients³.

An authorized generic skips all of that. It is marketed under the brand's new drug application (NDA) and needs no approval of its own, though FDA requires the NDA holder to notify the agency³ when it markets one. The holder may sell the brand and the authorized generic at the same time.

That last row produces a quirk. The Orange Book preface⁵ says a product distributed by or with the authorization of the applicant is considered therapeutically equivalent to the brand "even if the applicant's drug product is single source or coded as non-equivalent (e.g., BN)." So an authorized generic counts as equivalent even when its brand has no approved ANDA copies, or when the brand's listing carries a non-equivalence code. Because they sit under the brand's NDA, authorized generics do not appear as separate entries in the Orange Book.

Why brand companies launch them

Launches usually line up with the end of a brand's market exclusivity. Under the Hatch-Waxman framework, the first company to submit a substantially complete ANDA that challenges a listed patent with a Paragraph IV certification is generally eligible for 180 days⁶ of generic exclusivity. During that window FDA generally cannot give final approval to later Paragraph IV ANDAs for the same drug.

That exclusivity blocks other ANDA filers. It does not block the brand company, which can keep selling under its own NDA and can also sell the identical product without the brand name. An authorized generic launched during the 180 days turns a one-generic market into a two-generic market, and lets the brand keep a share of sales it would otherwise lose. GxRadar's piece on 180-day exclusivity covers how that window starts and how it can be forfeited.

What the FTC found

Formally titled Authorized Generic Drugs: Short-Term Effects and Long-Term Impact², the 2011 study measured both prices and the first filer's revenue.

Buyers paid somewhat less in the short run. The first-filing generic company, which had borne the cost and risk of the patent challenge, earned far less. The FTC also reported¹ that authorized generic competition had not substantially reduced generic companies' willingness to challenge brand patents. Prices typically keep falling as more ANDA generics arrive after the 180 days, a pattern GxRadar tracks in why generic prices fall as competitors enter.

No-authorized-generic promises in patent settlements

Settlements were the report's second theme, and they connect to the FTC's broader work on pay-for-delay deals. If an authorized generic can cut a first filer's revenue roughly in half, then a brand's promise not to launch one is worth a great deal to that filer. From fiscal 2004 through fiscal 2010, the FTC found, about 25 percent of patent settlements with first-filing generics paired such a promise with an agreement to delay generic entry, covering drugs with a combined market value of more than $23 billion¹.

In fiscal 2010 alone, 15 settlements combined a no-authorized-generic commitment with the generic's agreement to defer entry. Across 39 settlements with both terms from fiscal 2004 to 2010, generic entry came an average of 37.9 months after the settlement date, according to the same FTC release.

FDA's list of authorized generics

Congress created the list in the Food and Drug Administration Amendments Act of 2007⁷, signed Sept. 27, 2007, which added section 505(t) to the Federal Food, Drug, and Cosmetic Act. It directed FDA to publish "a complete list" of authorized generics, with the drug's trade name, the brand company and the date the authorized generic entered the market, and to update it quarterly.

Brand companies report authorized generics in the annual reports they file for each NDA, and the list covers products reported after January 1, 1999. FDA's authorized generics page³ was last updated on Oct. 5, 2026. The statute's definition excludes repackaging of the brand into blister packs, unit doses or similar packaging for institutions.

Researchers use the list to separate independent generic competition from brand-controlled competition when they study prices. The list has limits.

• It depends on what NDA holders report, so it is only as current as those reports.
• A listed product may since have been discontinued; the list records when marketing began.
• Because authorized generics are not separate Orange Book entries, a search there will not find them.

Spotting one at the pharmacy

Nothing on the bottle says "authorized generic." The clearest clues are a tablet or capsule that looks like the brand, an inactive ingredient list identical to the brand's, or a label naming the brand company or a distributor working with it. FDA notes that an authorized generic tablet or capsule may still carry a different color or marking, so a change in appearance is not proof either way. The NDC number on the label identifies the labeler, and a pharmacist can look up the application number behind any product and say whether it is an authorized generic.