Authorized Generics: Brand Quality at Generic Prices
By BetterBuyRx Editorial Team
Written for cost and savings education only — not medical advice, and not medically reviewed. Always confirm details with your doctor or pharmacist. See our methodology.
Last updated
An authorized generic is a brand-name drug sold without the brand name on the label, made by or for the original brand manufacturer using the exact same active and inactive ingredients. It doesn't need separate FDA approval since it's marketed under the brand's existing approval. This differs from a typical generic, made by a different manufacturer that only has to match the active ingredient and prove bioequivalence.
If you've picked up a generic prescription that looks unusually similar to the brand version, right down to the inactive ingredients, it might be an authorized generic rather than a typical generic. Here's what that distinction actually means for you.
What makes a drug an "authorized generic"
According to the FDA's listing of authorized generics, an authorized generic is a drug product approved under a brand company's existing New Drug Application (NDA) but marketed without the brand name. Because it's the same product manufactured under the same approval, it uses the exact same active and inactive ingredients as the brand-name version. This is fundamentally different from most generics, which are approved separately.
Search your medication on BetterBuyRx to check pricing on generic options for your prescription, since authorized generics, typical generics, and brand versions can all carry different price points at different pharmacies.
How this differs from a typical ANDA generic
Most generic drugs are approved through an Abbreviated New Drug Application (ANDA), a separate approval pathway described on the FDA's ANDA page. An ANDA generic is manufactured by a different company than the original brand, is only required to match the brand's active ingredient and demonstrate bioequivalence, and can use different inactive ingredients like fillers, binders, or dyes. An authorized generic skips this separate approval process entirely because it's the identical product, just without the brand name, sold under the original NDA.
Authorized generic vs. typical generic at a glance
| Feature | Authorized generic | Typical (ANDA) generic |
|---|---|---|
| Manufacturer | Same as brand, or licensed by brand company | Different, independent generic manufacturer |
| FDA approval pathway | Marketed under brand's existing NDA, no new approval needed | Requires separate ANDA approval |
| Inactive ingredients | Identical to brand | May differ from brand |
| Listed in FDA's Orange Book | No | Yes |
| Can launch during a competitor's 180-day exclusivity | Often yes | No, if blocked by another generic's exclusivity |
Why brand companies choose to sell authorized generics
Brand manufacturers sometimes launch an authorized generic specifically to compete in the generic-price segment of the market once true generic competition arrives, rather than losing that segment of sales entirely to independent generic makers. This can also occur as part of a patent litigation settlement between a brand company and a generic challenger. Because an authorized generic isn't a competing ANDA product, it isn't necessarily blocked by another generic manufacturer's 180-day first-generic exclusivity period, giving brand companies an avenue to participate in generic-tier pricing sooner than a new ANDA competitor could.
Compare prescription prices on BetterBuyRx to see how authorized generic, typical generic, and brand pricing compare for medications you take, since availability and pricing shift as new generic competition enters the market.
Are authorized generics always cheaper than the brand?
Authorized generics are generally priced below the brand-name version, similar to how typical generics are priced, though not always as low as competing ANDA generics once those become available, since ANDA generics often trigger more direct price competition. Pricing depends heavily on how many manufacturers are actively competing for a given drug at any given time.
How to find out if your medication has an authorized generic
The FDA maintains a public listing of authorized generics, though it's a fairly technical reference document intended for pharmacists and researchers rather than a simple consumer lookup tool. Your pharmacist is generally your best resource for finding out in practice whether an authorized generic version of your specific medication currently exists and what the price difference looks like compared to the brand and any competing generics.
Ask your pharmacist which option makes sense for you
Since authorized generics, typical generics, and brand-name drugs can all be chemically and functionally similar but priced differently, ask your pharmacist which version is available and most cost-effective for your specific prescription. Only your doctor can determine whether switching between these versions is medically appropriate for you, but pharmacists can walk you through the pricing differences.
The bottom line on authorized generics
Authorized generics offer a middle path between brand-name pricing and typical generic competition, being chemically identical to the brand but sold without the brand markup. Check prices near you on BetterBuyRx to see what's actually available and priced competitively for your medication. Prices vary by pharmacy, location, quantity, and eligibility.
Frequently asked questions
What makes an authorized generic different from a regular generic?
An authorized generic is the exact same drug as the brand-name product, made with the same active and inactive ingredients under the original brand's approval, just sold without the brand name on the label. A typical generic is made by a different manufacturer, only needs to match the active ingredient, and can have different inactive ingredients.
Does an authorized generic need separate FDA approval?
No. Because it's marketed under the original brand's existing approval, an authorized generic doesn't require a new, separate FDA approval application. The manufacturer notifies the FDA that it's marketing the product under the existing approval rather than filing a new abbreviated new drug application.
Why would a brand company sell an authorized generic of its own drug?
Brand manufacturers sometimes launch an authorized generic to compete directly with other generic manufacturers once a competing generic reaches the market, or as part of a settlement with a generic company, allowing them to capture some revenue in the generic-price segment rather than losing that business entirely.
Can an authorized generic launch before a competitor's 180-day exclusivity period ends?
Yes, in many cases. Since an authorized generic isn't the same type of approval as a competing ANDA generic, it isn't necessarily blocked by another generic manufacturer's 180-day marketing exclusivity period, which is one reason brand companies sometimes use this strategy.
Where can I find out if my medication has an authorized generic?
The FDA maintains a public listing of authorized generics, though it's a technical resource. Your pharmacist can also tell you whether an authorized generic version of your specific medication is currently available and what it might cost compared to the brand and typical generic versions.
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Compare prices & find savings
This guide is for cost and savings education only. It is not medical advice. Talk to your doctor or pharmacist before making any changes to your medications. Prices vary by pharmacy, location, quantity, and eligibility, and they change over time.
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