Priority vs Standard Review: How FDA Prioritizes Generic Drug Applications

When a generic drug company submits an application to the FDA, it doesn’t just wait in line like everyone else. The agency has two lanes: one for most applications, and another for the ones that matter most right now. Understanding the difference between priority review and standard review isn’t just about paperwork-it’s about when patients get access to affordable medicine, how much money a company makes, and whether a drug is made in the U.S. or overseas.

What’s the difference between priority and standard review?

The FDA sets clear deadlines for reviewing generic drug applications, called Abbreviated New Drug Applications (ANDAs). For standard review, the clock starts ticking the day the application is officially filed. The agency has 10 months to finish its evaluation. That’s the baseline. Most applications fall into this category.

Priority review cuts that time down to 8 months. It’s not just faster-it’s strategically targeted. The FDA doesn’t hand out priority status lightly. It’s reserved for cases where speed makes a real difference: first generics, drugs in short supply, or complex products that improve patient outcomes.

The difference isn’t just 2 months on paper. For a first generic, those 60 days can mean the difference between $200 million and $500 million in revenue. That’s because the first company to get approval gets 180 days of exclusive marketing rights. No other generic can enter the market during that time. That’s a huge incentive to get your application in early and make sure it’s perfect.

Who qualifies for priority review?

Not every generic drug gets priority. The FDA has specific rules. To qualify, an ANDA must meet one of these criteria:

• It’s the first generic version of a brand-name drug after all patents and exclusivity periods have expired.
• The drug is listed on the FDA’s Drug Shortages list under Section 506C of the Federal Food, Drug, and Cosmetic Act.
• The product represents a medically important advance over existing generics-like a new delivery system or improved stability.

The first generic is the most common reason. The FDA’s Orange Book tracks patent and exclusivity data, so companies know exactly when the door opens. In 2022, 92.7% of first generics received the 180-day exclusivity period, and nearly 83% of those priority applications were approved within the 8-month target.

Drug shortages are another big driver. If a life-saving medication-like an antibiotic or chemotherapy drug-is running out, the FDA fast-tracks any generic that can fill the gap. In 2022, over 150 drugs were on the shortage list. Getting one of those generics approved faster can literally save lives.

The new U.S. manufacturing priority pilot

In October 2023, the FDA launched something new: the ANDA Prioritization Pilot Program. This isn’t just about speed-it’s about reshaping the entire supply chain.

To qualify, a generic drug application must prove three things:

1. The bioequivalence studies were done in the United States.
2. The finished dosage form (the actual pill or injection) is manufactured in the U.S.
3. All active pharmaceutical ingredients (APIs) come from U.S.-based suppliers.

Why? Because the pandemic exposed how fragile global supply chains are. In 2021, the FDA found that 80% of APIs were made overseas. That means if a factory in India or China shuts down, U.S. patients could go without critical medications.

This pilot is a direct response. The FDA wants to bring more manufacturing home. They estimate 45 to 60 applications per year will qualify. And the reward? A faster 8-month review clock.

But here’s the catch: only 12.3% of generic companies currently meet all three criteria. Most APIs still come from Asia or Europe. Excipients-those inactive ingredients that hold the pill together-are often sourced overseas too. One regulatory manager on Reddit put it bluntly: “The domestic manufacturing requirement is noble but unrealistic for complex generics.”

Still, companies are adapting. Major players like Teva and Sandoz have increased their U.S. bioequivalence testing by 22% since 2022. Contract research firms like Covance are seeing a 35% surge in U.S.-based studies. It’s not easy, but the financial upside is too big to ignore.

Why do so many applications get rejected or delayed?

Even if you qualify for priority review, you’re not guaranteed approval. In 2022, over 31% of ANDAs received a Complete Response Letter (CRL)-meaning the FDA found problems that needed fixing.

The biggest issue? Chemistry, manufacturing, and controls (CMC). That’s the technical part of the application where companies prove their generic is identical to the brand drug in how it’s made. Poorly written CMC sections account for nearly half (47.2%) of all review delays.

Each CRL adds about 4.2 months to the timeline. And the average ANDA needs 1.7 review cycles to get approved. That means even a priority application can stretch past 10 months if it’s not perfect the first time.

To fix this, the FDA now encourages pre-submission meetings. Companies can meet with regulators months before filing to get feedback on their data. In 2020, only 41% of sponsors did this. By 2023, that number jumped to 63%. And the results? First-cycle approval rates rose from 24% to 39%.

What about complex generics?

Not all generic drugs are created equal. A simple tablet? Easy. An inhaler? A topical cream? A slow-release capsule? Those are complex generics. They’re harder to copy because their performance depends on how they’re made-not just what’s inside.

In 2022, complex generics made up 18.3% of pending applications but only 9.7% of approvals. The FDA launched a dedicated pilot in January 2023 to help with these. Companies get early scientific advice, which reduces the chance of costly mistakes later.

This matters because complex generics are where the next wave of savings will come from. They’re often used for chronic conditions like asthma, diabetes, and heart disease. Getting them approved faster means more patients get affordable treatment.

What’s next for FDA generic reviews?

The FDA isn’t slowing down. By late 2024, they plan to roll out AI tools to help review straightforward ANDAs. In internal tests, AI reduced review times by nearly 19% for simple applications. That means reviewers can focus more time on complex cases.

The agency also expects 1,275 ANDA submissions in FY 2024-a 12.5% increase from the year before. Priority reviews are expected to make up 32.8% of those, up from 28.4% in 2022.

Long-term, experts predict these changes could cut the average time from patent expiry to generic approval from 2.7 years to under 2.3 years by 2026. That could save the U.S. healthcare system over $18 billion annually.

What does this mean for patients and pharmacies?

For patients, it means more affordable options arrive faster. For pharmacies, it means fewer shortages and more choices on the shelf. For manufacturers, it’s a race-between speed, cost, and location.

The system isn’t perfect. Some companies still struggle to meet U.S. manufacturing demands. Some applications still get bogged down in technical details. But the direction is clear: the FDA is pushing for faster, safer, and more resilient access to generic drugs.

The bottom line? Priority review isn’t a favor. It’s a tool. And the rules are changing-not just to speed things up, but to make sure the medicines we rely on are made where we can trust them.