Recent Authorized Generic Approvals: Current Options and Market Trends

When a brand-name drug loses patent protection, patients and pharmacists often expect a flood of cheap generic alternatives. But sometimes, the first generic you see isn’t a typical generic at all-it’s an authorized generic. These are exact copies of the brand drug, made by the same company, just sold under a different label. They’re not cheaper than the brand at first, but they’re identical in every way. And right now, the number of these drugs hitting the market is dropping-not rising.

What Exactly Is an Authorized Generic?

An authorized generic is not a separate drug. It’s the exact same pill, capsule, or injection as the brand-name version, made in the same factory, with the same active and inactive ingredients. The only difference? The label. Instead of saying "Lyrica" or "Xgeva," it might say "Pregabalin" or "Denosumab" with a different company name on the box. The FDA defines it clearly: it’s a listed drug approved under a New Drug Application (NDA) that’s sold under a different trade name or packaging.

Unlike regular generics-which must prove they’re bioequivalent through an Abbreviated New Drug Application (ANDA)-authorized generics skip all that. They’re not "similar" to the brand. They are the brand, just rebranded. That’s why pharmacists and doctors trust them. If your patient was stable on the brand, switching to an authorized generic won’t cause side effects from different fillers or coatings. A 2024 JAMA study found patients stayed on authorized generics 15-20% longer than traditional generics, mostly because doctors didn’t worry about effectiveness.

Why Are There So Few New Ones in 2025?

Back in 2022, there were 37 new authorized generics approved. In 2025? Only 12. That’s a 68% drop in just three years.

The reason isn’t lack of demand. It’s regulatory pressure. The Federal Trade Commission (FTC) has cracked down on what’s called "pay-for-delay" deals-where brand companies pay generic makers to delay entry. One big example: Teva paid to block generic versions of Copaxone, and in 2023, the FTC forced them to pay $1.2 billion. Since then, brand companies have gotten smarter. Instead of launching their own authorized generics to undercut competitors, they’re shifting to biosimilars.

Take Stelara (ustekinumab). In 2025, five biosimilars were approved: Otulfi, Selarsdi, Yesintek, Pyzchiva, and another. These aren’t authorized generics. They’re made by different companies, have different names, and go through their own approval process. But they’re cheaper, and they don’t trigger FTC scrutiny the way authorized generics do. So brand companies are betting on biosimilars instead.

What Authorized Generics Are Available Right Now?

The FDA’s latest list, updated October 10, 2025, added only two new authorized generics:

• Sodium oxybate (formerly Xyrem), now sold under a different label by Jazz Pharmaceuticals
• Plecanatide (formerly Trulance), distributed by Ironwood Pharmaceuticals under a generic name

These are exceptions. Most authorized generics on the market today have been around for years. You’ll find them for drugs like:

• Simvastatin (Zocor)
• Fluticasone/salmeterol (Advair)
• Metoprolol succinate (Toprol XL)
• Pregabalin (Lyrica)
• Sertraline (Zoloft)

But here’s the catch: you won’t see "Authorized Generic" on the box. Pharmacies don’t label them that way. You have to check the FDA’s official list or ask your pharmacist to look up the product code in the Orange Book. A 2025 survey found 63% of pharmacists couldn’t tell an authorized generic from a regular one without checking the database. That means you might be getting one-and not even know it.

Are They Cheaper? Not Always.

The biggest myth about authorized generics is that they’re cheap. They’re not. Because they’re made by the brand company, they often launch at prices just 10-15% below the brand. Compare that to traditional generics, which can be 80% cheaper. On Drugs.com, users reported the authorized generic of Lyrica was only $5 cheaper than the brand at their pharmacy. Meanwhile, the regular generic was $15.

And insurance companies know this. Some PBMs (pharmacy benefit managers) now refuse to cover authorized generics because they don’t get the same rebates as traditional generics. A Reddit user shared that Blue Cross BCBS dropped coverage for the authorized generic of Jardiance-even though it’s identical to the brand-and forced patients back to the expensive version just to get a better rebate from the generic maker.

Who Benefits the Most?

Not everyone. But some patients do.

For drugs with a narrow therapeutic index-where tiny changes in dosage or formulation can cause big problems-authorized generics are the safest switch. Think: seizure meds like levetiracetam, blood thinners like warfarin, or thyroid drugs like levothyroxine. A 2025 NEJM article called them an "underutilized patient safety tool" because they eliminate formulation variability.

Patients who’ve had bad reactions to traditional generics often report stability after switching to an authorized version. One pharmacist on Reddit shared that patients on brand sertraline had anxiety spikes or nausea with generic versions-until they switched to Pfizer’s authorized generic. No changes in symptoms. Just a different label.

What’s Next? The Law Might Change

There’s a bill in Congress right now called the RELIEF Act (H.R. 4086). If it passes, it would force authorized generics to be priced the same as traditional generics. That would remove the main reason brand companies make them: to keep some profit while pretending to compete.

Right now, brand companies use authorized generics as a way to delay the full impact of generic competition. They get to sell the same drug at a slightly lower price, while still keeping control of the supply chain. If the RELIEF Act becomes law, that strategy could vanish. That might mean more traditional generics-and more real savings-for patients.

What Should You Do?

If you’re on a brand-name drug that’s gone generic:

• Ask your pharmacist: "Is there an authorized generic for this?"
• Check your prescription label. If the manufacturer name doesn’t match the brand, ask if it’s the same product.
• Compare prices. If the "generic" is only $5 cheaper than the brand, it might be an authorized one.
• If you’ve had side effects with regular generics, ask your doctor to prescribe the authorized version.

Don’t assume all generics are the same. Some are. Some aren’t. And the ones that are exact copies? They’re harder to find than ever.