When you need a prescription drug but can’t afford the brand-name version, you’re counting on generics. They’re cheaper, just as safe, and legally required to work the same way. But how long does it actually take for the FDA to approve them? If you’re a patient, a pharmacist, or even a manufacturer, knowing the real timeline matters - because delays can mean longer waits for affordable medicine.
What’s the standard timeline for FDA generic approval?
The FDA’s goal for a standard generic drug application - called an Abbreviated New Drug Application, or ANDA - is 10 months after the application is officially accepted. That’s the clock starting point. It’s not from the day you submit the paperwork. It’s from the day the FDA says, “We’ve got everything we need to start reviewing.”
That 10-month target isn’t arbitrary. It’s part of the Generic Drug User Fee Amendments (GDUFA), a funding and performance agreement between the FDA and drug makers. Since GDUFA started in 2012, review times have dropped steadily. In 2020, the median approval time was over 30 days longer than it is today. By late 2025, the median approval time had fallen to just 25 days for completed applications that didn’t need revisions.
But here’s the catch: 25 days is the median for applications that get approved on the first try. Most don’t.
Why do some approvals take much longer?
Not all generic drugs are created equal. A simple tablet - like generic ibuprofen - is easy to copy. The chemistry is straightforward. The manufacturing process is well understood. Those applications often get approved quickly.
But what about a complex generic? Think of a nasal spray, an injectable, or a drug that needs a special coating to release slowly in your gut. These are harder to replicate. The FDA has to dig deeper into how the drug behaves in the body, whether the manufacturing equipment can produce it consistently, and if the final product matches the brand-name version exactly.
For these complex generics, approval can take 18 to 24 months - sometimes even longer. One Reddit user reported a nasal spray generic taking 1,087 days from submission to approval. That’s almost three years. And it’s not unusual.
The FDA calls these “first generics” - the very first version of a drug approved after the brand-name patent expires. They’re a big deal. If there’s no generic on the market, patients pay full price. The FDA gives these applications extra attention and faster review slots. But even then, complexity slows things down.
What happens during the review process?
The process isn’t just a waiting game. It’s a multi-step check.
First, the FDA does a 60-day “filing review.” This isn’t about the science yet. It’s about paperwork. Did you include all the required forms? Is the chemistry data complete? Are the manufacturing details clear? If something’s missing, the FDA sends back a “refuse to file” letter. You fix it and resubmit. The clock doesn’t start until they accept it.
Then comes the 10-month review. FDA scientists look at:
- How the drug dissolves in the body (bioequivalence)
- Manufacturing quality and consistency
- Stability data - does it last as long as the brand?
- Labeling accuracy
At the end of that period, you get one of two responses:
- Approval - your drug can hit the market.
- Complete Response Letter (CRL) - the FDA found problems. You have to fix them and resubmit.
Here’s the kicker: as of Q2 2025, 42.3% of applications received a CRL on the first try. That’s up from 37.8% in 2024. It means more applications are being flagged early - good for safety, bad for timelines. Each CRL adds 3 to 6 months to the process. If you get two or three CRLs, you’re looking at 2+ years.
Can the process be faster?
Yes - and it’s getting faster.
The FDA introduced a new program called the Commissioner’s National Priority Voucher (CNPV) in 2025. It’s designed for high-need generics - like drugs in shortage or for rare conditions. Under CNPV, review time drops from 10 months to 1 to 2 months. That’s not a rumor. It’s happening. The first approvals under this program came through in early 2025.
They’re also using artificial intelligence to speed things up. AI now helps screen applications for missing data, flag inconsistent chemistry, and even predict potential bioequivalence issues. In pilot programs, AI cut review time by 15.8% for standard generics.
Another change: “rolling review.” Instead of waiting to submit your entire application, you can send parts as they’re ready - like submitting your chemistry data now, your manufacturing details next month. This cuts down on the 60-day filing delay.
For certain oncology generics, the FDA’s “Real-Time Oncology Review” pilot has slashed approval times by 40%. That’s now being tested for other high-demand drug classes.
Who gets priority?
The FDA doesn’t review applications in the order they’re received. They prioritize:
- First generics (no competition yet)
- Drugs in shortage (like insulin, epinephrine, or antibiotics)
- Drugs for pediatric or rare diseases
- Applications from small businesses or those with fee waivers
That’s why you’ll see a generic for epinephrine injection approved in January, while a similar tablet for a common blood pressure drug waits months. It’s not about who applied first - it’s about who needs it most.
What’s the real-world impact?
Every day the FDA delays a generic approval, patients pay more. Generic drugs make up 90% of prescriptions in the U.S. but only 23% of total drug spending. Over the past decade, they’ve saved the healthcare system $1.7 trillion.
When the FDA approves a first generic, prices can drop by 80% or more within months. A drug that costs $500 a month can fall to $50. That’s life-changing for people on fixed incomes.
But delays hurt. If a generic for a diabetes drug is held up for 18 months, thousands of patients pay extra. That’s why industry groups are pushing the FDA to hit its 2027 goal: 20-day median approval time for standard generics and 10 days for priority ones.
What can manufacturers do to speed things up?
If you’re a company applying for approval, here’s what works:
- Submit a clean, complete application - missing data is the #1 reason for delays. Use the FDA’s checklists.
- Request a pre-submission meeting - talk to the FDA before you file. They’ll tell you what they need. Teva and Viatris do this consistently - and they’re the top two generic makers in the U.S.
- Don’t cut corners on manufacturing details - the FDA checks your factory. If your process isn’t consistent, they’ll reject you.
- Use rolling review - submit what you have now, not everything at once.
Small companies can apply for fee waivers - but only 4.7% of applicants qualify. If you’re eligible, use it. It’s not just about saving money. It’s about getting your application reviewed faster.
Is faster always better?
Some experts worry. Dr. Peter Lurie from the Center for Science in the Public Interest says rushing approvals without enough scrutiny could lead to unsafe drugs. The FDA’s response? They’re using a risk-based approach. High-risk products get more scrutiny. Low-risk ones get faster reviews.
So far, there’s no evidence of safety issues from accelerated reviews. The FDA still requires the same bioequivalence standards. The only thing that’s changed is how quickly they review the data.
Industry surveys show 68% of manufacturers think the current 10-month timeline is “acceptable but improvable.” The biggest complaint? Inconsistent feedback from reviewers. One team says your data is solid. Another says it’s incomplete. That’s why pre-submission meetings are becoming essential.
What’s next for FDA generic approvals?
By 2027, the FDA aims to approve 90% of standard applications on time. That’s ambitious. But with AI, rolling review, and the CNPV program, they’re on track.
The real test will be funding. GDUFA III runs through 2027. After that, Congress needs to renew it. If funding drops, review times could stall - or even creep back up.
For now, the trend is clear: generic approvals are getting faster, smarter, and more targeted. The goal isn’t just speed - it’s getting the right drugs to the right patients at the right time.
How long does it take the FDA to approve a generic drug?
The FDA aims to approve a standard generic drug application within 10 months after accepting it. For simple, low-risk generics, the median approval time is now around 25 days. But complex generics - like injectables or nasal sprays - can take 18 to 24 months. If the FDA issues a Complete Response Letter, each revision adds 3 to 6 months.
What is a Complete Response Letter (CRL) and how does it affect approval time?
A Complete Response Letter is the FDA’s official notice that your generic drug application has deficiencies and cannot be approved as submitted. Common issues include incomplete chemistry data, manufacturing inconsistencies, or bioequivalence concerns. About 42% of applications receive a CRL on the first review. Each CRL typically adds 3 to 6 months to the timeline while the manufacturer fixes the issues and resubmits.
Can a generic drug be approved faster than 10 months?
Yes. The FDA’s Commissioner’s National Priority Voucher (CNPV) program allows certain high-priority generics - such as those for drugs in shortage or with no existing generic competition - to be reviewed in just 1 to 2 months. Rolling review and AI-assisted screening are also reducing review times for many applications.
Why do some generic drugs take longer to approve than others?
Complex formulations - like inhalers, injectables, or extended-release tablets - require more detailed testing to prove they work the same as the brand-name drug. The FDA also prioritizes first generics and drugs in shortage, which may move ahead of simpler generics submitted earlier. Manufacturing quality and application completeness also play major roles.
How does the FDA decide which generic applications to review first?
The FDA prioritizes applications for first generics, drugs in shortage, pediatric or rare disease treatments, and those from small businesses with fee waivers. It does not use a first-come, first-served system. Instead, it focuses on public health need - meaning a generic for insulin may be approved before one for a common blood pressure drug, even if the latter was submitted first.