When you're trying to save money on prescription drugs, you might have heard about authorized generics. These aren't your typical generics. They're made by the same company that makes the brand-name drug, but sold under a different label - often at a lower price. The problem? Finding accurate, up-to-date information on which ones exist and where to get them isn't always easy. The U.S. Food and Drug Administration (FDA) keeps the official list, but it's not as straightforward as searching Google.
What Exactly Is an Authorized Generic?
An authorized generic is the exact same drug as the brand-name version - same active ingredients, same dose, same shape, same way it works in your body. The only difference? It doesn't carry the brand name on the label. It might look different - maybe a different color or marking - but it's chemically identical. These are not made by a separate generic company. They're produced by the original brand manufacturer, often under a different label, and sold at a lower price point.
Here's why that matters: when a brand-name drug's patent is about to expire, other companies can apply to make generic versions. But the brand company can also launch its own generic version - an authorized generic - before the first generic even hits the market. This can slow down price drops because consumers now have two options: the brand name or the brand's own cheaper version. The FDA tracks these because they're not listed in the Orange Book, which is where most people look for generics.
Where to Find the Official FDA List
The FDA maintains the only official public list of authorized generics. You won't find them in the Orange Book. You won't find them in Drugs@FDA. The list lives on a specific page: fda.gov/drugs/abbreviated-new-drug-application-anda/fda-list-authorized-generic-drugs.
This page includes a downloadable PDF that updates every three months. The most recent version as of October 10, 2025, contains over 850 entries. Each entry lists:
- The brand name (e.g., ACTIQ, ARTHROTEC, CLEOCIN T)
- The dosage form and strength (e.g., 1200 mcg lozenge, 50 mg/200 mcg tablet)
- The name of the brand manufacturer (e.g., Cephalon, LLC; Pfizer Inc.)
- The date the authorized generic entered the market (based on annual reports, not exact launch dates)
The file is about 1.09 MB - large enough to be useful, but not searchable like a website. You have to download it, open it in Adobe Reader or another PDF viewer, and use Ctrl+F to search for a drug name.
Why the List Is Hard to Use
Here's the catch: the FDA list doesn't tell you if a drug is still being sold. It only tells you when the manufacturer first reported it in their annual report. That means:
- A drug listed as "entered market on June 11, 2003" might have been discontinued in 2020.
- A drug you see on the list might not be available at your local pharmacy.
- The "date" you see isn't the exact launch date - it's the reporting period. The FDA admits they don't know the real date.
Pharmacists and pharmacy buyers report that 5 out of 8 drugs they check on the list aren't actually available from wholesalers. That's not a mistake - it's how the system works. The FDA doesn't track whether a product is still being made or sold. They only track what manufacturers report once a year.
How to Verify If an Authorized Generic Is Actually Available
If you're a patient, pharmacist, or provider trying to find a low-cost option, don't rely on the FDA list alone. Cross-check with these tools:
- National Drug Code (NDC) Directory - Go to fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory. Search by drug name or NDC number. If you find an active NDC, it's likely still on the market.
- Commercial databases - Tools like IQVIA National Sales Perspectives track actual sales and distribution. They show which authorized generics are still being shipped to pharmacies.
- Your pharmacy or wholesaler - Ask if they carry the authorized generic version. Many pharmacies know which ones are still active because they order them regularly.
For example, if you see "CLEOCIN T 1% gel" on the FDA list, check the NDC Directory. If it shows an active NDC from Pfizer, then your pharmacy might be able to order it. If not, it's probably discontinued.
Who Uses This List - And Why
The FDA list isn't meant for patients looking for cheap prescriptions. It's meant for:
- Pharmaceutical companies tracking competitors
- Market analysts studying drug pricing trends
- Regulatory agencies like the FTC, which monitor anti-competitive behavior
- Researchers studying how brand manufacturers use authorized generics to delay price drops
A 2023 study found that 854 authorized generics were launched between 2010 and 2019. Pfizer alone had 47 on the list. Teva and Mylan (now Viatris) were also major players. These companies use authorized generics to stay competitive - sometimes even before the first generic hits the market.
But here's the twist: authorized generics often don't save consumers much. A 2020 JAMA study found many authorized generics were priced only slightly lower than the brand name. So while they increase competition, they don't always mean big savings.
What’s Changing in 2026
The FDA has said it plans to replace the PDF list with a searchable, online database by mid-2026. This is a direct response to user feedback. Right now, people have to download a new PDF every quarter and manually search through hundreds of entries. That’s not practical.
The new system will likely include:
- Search by drug name, strength, or manufacturer
- Status indicators (active, discontinued)
- Link to NDC numbers
- More frequent updates
Until then, the PDF remains the only official source. And while it's not perfect, it's still the only place that tells you which brand-name companies have launched their own generics.
Common Mistakes People Make
- Mixing up authorized generics with regular generics - They’re not the same. Regular generics are approved under ANDAs and appear in the Orange Book. Authorized generics are under NDAs and only appear on this list.
- Assuming "entered market" means "currently sold" - It doesn’t. Many entries are years old and no longer available.
- Using the list as a pricing guide - The FDA doesn't track prices. An authorized generic might cost $20, $50, or $100 - it depends on the pharmacy and wholesaler.
Bottom Line
The FDA's authorized generics list is a valuable tool - but only if you understand its limits. It's not a shopping guide. It's not a real-time inventory. It's a historical record of what brand manufacturers have reported. If you're looking for low-cost drugs, use the list to identify possibilities, then verify availability with your pharmacist or the NDC Directory. Don't assume a drug on the list is still available. Always double-check.
For now, the PDF is the only official source. But by mid-2026, that could change. Keep an eye on the FDA's website - a better, searchable tool is coming.
Is the FDA authorized generics list the same as the Orange Book?
No. The Orange Book lists traditional generic drugs approved under Abbreviated New Drug Applications (ANDAs) and includes therapeutic equivalence ratings. Authorized generics are not listed there because they are marketed under the original brand's New Drug Application (NDA), not an ANDA. The FDA's authorized generics list is a separate document that only includes drugs made by the brand manufacturer but sold without the brand name.
Can I use the FDA list to find cheaper drugs at my pharmacy?
You can use it as a starting point, but don't expect every drug on the list to be available. The FDA list doesn't show current market status - only when a product was first reported. Many authorized generics are discontinued or never distributed widely. Always check with your pharmacy or use the National Drug Code Directory to confirm availability.
Why don't authorized generics always cost less than the brand name?
Because they're often priced just below the brand name to maintain profit margins. The brand manufacturer doesn't need to slash prices to compete - they already own the product. Studies show authorized generics sometimes offer only marginal savings, especially compared to traditional generics that come from separate companies competing on price.
How often is the FDA authorized generics list updated?
The list is updated quarterly, as required by law. The most recent version as of October 10, 2025, is the latest available. However, because manufacturers submit annual reports, the data can be up to a year behind. The FDA is planning to replace the PDF with a live database in 2026 to improve timeliness.
Are authorized generics safer or more effective than regular generics?
No. Authorized generics are chemically identical to the brand-name drug - same active ingredient, same dosage, same quality standards. They are considered therapeutically equivalent by the FDA. The only difference is the label. Whether it's made by the brand company or a generic manufacturer, the drug works the same way in your body.
