Priority vs Standard Review: How FDA Prioritizes Generic Drug Applications

The U.S. Food and Drug Administration doesn’t treat every generic drug application the same. Two paths exist: priority review and standard review. The difference isn’t just paperwork-it’s money, timing, and access to life-saving medicines. For companies, getting priority review can mean entering the market two months faster, which translates to hundreds of millions in extra revenue. For patients, it can mean getting affordable drugs sooner, especially when shortages hit.

What’s the difference between priority and standard review?

The FDA’s review clock starts the moment an Abbreviated New Drug Application (ANDA) is officially filed. For standard review, the target completion date is 10 months. For priority review, it’s 8 months. That two-month gap might seem small, but in the generic drug world, it’s everything.

Standard review covers most applications-about 70% of all ANDAs submitted. These are drugs with existing generics already on the market, or those that don’t meet special criteria. Priority review is reserved for a select few: first generics (the very first generic version after a brand-name drug’s patent expires), drugs in shortage, or complex generics that offer a meaningful improvement over existing options.

The FDA tracks this closely. In 2022, 83.1% of priority review applications met the 8-month goal, compared to 72.3% of standard applications. Why the gap? Priority applications get more attention from reviewers, faster internal routing, and fewer delays in scheduling meetings. But it’s not just about speed-it’s about impact.

Who qualifies for priority review?

Not every company can just ask for priority review. The FDA has strict rules. The biggest category is first generics. If you’re the first to file a complete ANDA after a brand-name drug’s patent or exclusivity ends, you automatically qualify. These drugs often come with 180 days of market exclusivity, meaning no other generic can enter during that time. That’s why companies race to be first.

The second major category is drugs in shortage. The FDA defines a shortage as a situation where the supply of a drug can’t meet patient demand, and it’s serious enough to affect health outcomes. In 2022, nearly 40% of priority review applications were for drugs on the official shortage list-things like antibiotics, chemotherapy agents, or injectables used in hospitals.

There’s also a third path: complex generics that are medically important. These aren’t just harder to make-they’re harder to copy. Think inhalers, topical creams, or long-acting injectables. If your version is safer, more effective, or easier to use than what’s already out there, the FDA may grant priority status.

The new U.S. manufacturing pilot program

In October 2023, the FDA launched a game-changing addition to the priority review system: the ANDA Prioritization Pilot Program. This isn’t just about speed anymore-it’s about supply chain security.

To qualify, a generic drug application must meet three strict criteria:

• Bioequivalence testing done in the United States
• Finished dosage form manufactured in the U.S.
• Active pharmaceutical ingredient (API) sourced entirely from U.S.-based suppliers

This was a direct response to the pandemic. In 2021, the FDA found that 80% of APIs for U.S. drugs were made overseas-mostly in India and China. When global supply chains broke down, shortages exploded. The pilot program rewards companies that bring manufacturing back home.

The catch? Only 12.3% of current ANDA sponsors meet all three requirements. That’s why big players like Teva and Sandoz are investing heavily. According to IQVIA, major generic manufacturers increased their U.S.-based bioequivalence testing capacity by 22% in just one year. Contract research firms like Covance are seeing a 35% surge in U.S. trials.

Why does this matter for patients and the healthcare system?

Generic drugs make up 88.6% of all prescriptions filled in the U.S., but they cost only 15.3% of what brand-name drugs do. In 2022, they saved the system $370 billion. But savings only happen if those drugs are available.

Priority review gets drugs to market faster. For a first generic, that two-month head start can mean $200-500 million in extra revenue. That’s why companies fight to be first. But it’s not just about profits. When a drug is in shortage-say, a common antibiotic or insulin-the FDA fast-tracks approval to prevent harm. Patients waiting weeks or months for a critical drug don’t care about corporate profits. They just need access.

The U.S. manufacturing pilot adds another layer. If more generic drugs are made here, supply chains become more resilient. The FDA aims to raise the share of U.S.-manufactured generics from 28% to 40% within five years. That’s not just good for national security-it’s good for consistent availability.

What’s holding companies back?

Even with the incentives, many generic manufacturers struggle. The biggest hurdle? Complexity. Nearly one-third of ANDAs get a Complete Response Letter (CRL) in the first round, usually because of issues with chemistry, manufacturing, or controls (CMC). On average, an ANDA needs 1.7 review cycles to get approved. Each cycle adds about four months to the timeline.

That’s why more companies are using the FDA’s pre-submission meetings. In 2020, only 41% of sponsors met with the FDA before filing. By 2023, that number jumped to 63%. These early discussions help companies fix problems before they submit, improving first-cycle approval rates from 24.1% to 38.7%.

The FDA also launched a Complex Generic Drug Product Pilot Program in early 2023 to help with harder-to-copy products like inhalers and topical gels. These make up 18.3% of pending applications but only 9.7% of approvals. With more guidance, that gap is starting to close.

What’s next for FDA generic reviews?

The FDA is testing AI tools to speed up reviews. In internal trials, AI reduced review times for simple applications by nearly 19%. By late 2024, these tools could be rolled out to handle routine checks-like verifying labeling consistency or checking for duplicate patents.

Industry analysts predict that by 2026, these changes could cut the average time from patent expiry to generic approval from 2.7 years to around 2.3 years. That’s 4.3 months faster. If realized, that could save the U.S. healthcare system an extra $18.7 billion a year.

The future isn’t just about faster approvals-it’s about smarter ones. The FDA is moving from a reactive system to a proactive one. Priority review isn’t just a reward anymore. It’s a tool to shape the market, ensure supply, and protect public health.

How do you know if your drug qualifies?

If you’re a generic manufacturer, ask yourself:

• Is this the first generic for this brand-name drug? If yes, you likely qualify for priority review.
• Is this drug on the FDA’s shortage list? If yes, you’re eligible.
• Are you manufacturing the finished product and sourcing your API in the U.S.? If yes, you can apply for the pilot program.
• Is this a complex product like an inhaler or injectable? If yes, consider the Complex Generic Pilot for early feedback.

Don’t wait until submission. Talk to the FDA early. Use their guidance documents. Submit complete applications. The system rewards preparation-not just speed.