Recent Patent Cases and Generic Delays: 2023-2025 Examples

When the FDA approves a generic drug, you’d expect it to hit pharmacy shelves soon after. But in reality, many approved generics sit on the shelf-literally-for years. Between 2023 and 2025, this gap between approval and availability became more visible than ever. Patients, pharmacists, and hospitals kept asking: why can’t we get this drug? The answer isn’t about safety or quality. It’s about patents.

Why Approval Doesn’t Mean Availability

The FDA approved 63 first-time generic drugs by late September 2025. That sounds like progress. But according to a 2024 study in the Journal of Generic Medicines, the average time between FDA approval and actual market launch stretched to 3.2 years. That’s over three years of patients paying full price for brand-name drugs while generics sit waiting.

This isn’t a glitch. It’s the system working as designed-except the design is broken. Under the Hatch-Waxman Act, generic companies can challenge a brand-name drug’s patents by filing a Paragraph IV certification. That triggers a 30-month legal stay. The brand company sues. The FDA can’t give final approval until the court rules, the patent expires, or the 30 months run out. Even if the patent is weak, the delay still happens.

In 2024, 68% of all generic applications included a Paragraph IV challenge. That’s nearly seven in ten. And the number of patents listed per drug? It jumped to 14.7 in 2025, up from 12.3 in 2020. That’s not innovation. That’s a legal wall.

Patent Thicketing: The Real Enemy

Brand-name companies aren’t just defending one patent anymore. They’re building thickets-dozens, sometimes hundreds-of overlapping patents covering everything from pill coatings to manufacturing methods. These aren’t always strong patents. Many would never hold up in court. But they don’t need to. They just need to delay.

Take Humira. Its core patent expired in 2016. But AbbVie filed over 240 related patents. That stretched its monopoly until 2023. A 2025 analysis by RBC Capital Markets found that the 30-month stay is now used as a strategic tool. Companies file lawsuits even when they know they’ll lose, just to buy time.

Dr. Aaron Kesselheim from Harvard Medical School put it bluntly: “The current patent thicketing strategies have extended monopolies beyond the intended 20-year term by an average of 3.7 years per drug.” That’s not just a delay. That’s an extension of monopoly power.

Who Gets Hurt the Most?

The people paying for this delay? Patients. A 2025 survey by Patients For Affordable Drugs Now found 412 documented cases where patients skipped doses or went without medication because the generic wasn’t available. For drugs like Xarelto, Eliquis, or Trulicity, the brand-name version costs around $487 a month. The generic? Around $85. That’s an 82% price drop. But patients don’t see it.

Pharmacists are the front line. A pharmacist on Drugs.com wrote in August 2025: “We had the generic for Xarelto approved last November but still can’t get it-the brand company filed three new patents last month. Now we’re looking at another 30-month delay.”

Hospitals are suffering too. The American Society of Health-System Pharmacists reported that 78% of hospital pharmacy directors see patent delays as a major contributor to drug shortages-especially for cancer drugs. Of the 15 oncology injectables in short supply between 2023 and 2025, 14 were held up by patent litigation.

Why Some Generics Move Faster Than Others

Not all generics face the same delays. Simple oral pills-like metformin or lisinopril-move quicker. Only 63% of delays for these are tied to patents. But for complex generics? The numbers are brutal.

Injectables, inhalers, and other complex formulations? 89% of delays are patent-related. Why? Because these drugs are harder to copy. The FDA requires more data. And brand companies know that. So they file more patents on delivery systems, solvents, and packaging. Each one adds another legal hurdle.

The therapeutic area matters too. Oncology generics take the longest-4.1 years on average between approval and launch. Cardiovascular drugs? 2.8 years. Central nervous system drugs? 2.3 years. That’s not random. It’s money. Cancer drugs are the most expensive. The financial incentive to delay competition is highest there.

The U.S. vs. The Rest of the World

The U.S. is an outlier. In Europe, the average time between generic approval and market launch is just 1.7 years. Why? Because their patent systems don’t allow the same kind of legal stalling. No 30-month automatic stay. No patent thickets. Courts move faster. And regulators don’t wait for lawsuits to clear before approving generics.

The U.S. system was meant to balance innovation and access. But today, it favors the former at the expense of the latter. The Congressional Budget Office estimated in August 2025 that these delays cost Medicare Part D $3.2 billion a year in unnecessary spending. That’s billions of dollars that could’ve gone to patient care, not corporate profits.

Who’s Trying to Fix This?

Some reform is happening. The Federal Trade Commission filed seven enforcement actions between 2024 and 2025 against companies using patent tactics to block generics. One case against Jazz Pharmaceuticals over Xyrem ended in February 2025 with a settlement forcing earlier generic entry.

The FDA is also trying. Dr. Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research, admitted in May 2025 that patent litigation is outside their control-but they’re working to clean up the Orange Book. That’s the list of patents linked to brand drugs. For years, companies listed patents that had nothing to do with the drug’s active ingredient. Now, the FDA is cracking down on that.

The CREATES Act, passed in 2020 but still stalled in Congress, would force brand companies to provide samples to generic makers so they can test their versions. Without samples, you can’t even start the approval process. That’s another hidden barrier.

What’s Changing on the Ground?

Generic manufacturers are adapting. They’re starting patent research 48 to 60 months before a patent expires. Legal costs? They’ve jumped from $9.3 million per case in 2023 to $12.7 million in 2025. That’s a 36% increase. Only big players can afford this. Small and mid-sized generic companies-those making under $500 million a year-are getting squeezed. 63% of delayed generics involve these smaller firms.

Supply chains are another focus. In 2022, generic companies had an average of 1.8 approved suppliers for active ingredients. By 2025, that number jumped to 3.4. Why? Because 37% of delays between 2023 and 2025 were tied to API shortages. If you can’t get the raw material, even a cleared patent won’t help.

The FDA’s new AI-assisted review system cut review times by 22% for non-patent cases. But for those caught in litigation? No change. The 30-month stay still blocks everything.

The Bottom Line

The system isn’t broken because it’s inefficient. It’s broken because it’s being exploited. Patent laws meant to protect innovation are now being used to block competition. The FDA approves the drugs. The courts delay them. Patients pay the price.

There’s no quick fix. But the signs are clear: the current model is unsustainable. Patients need access. Hospitals need stability. And the cost of delay is no longer just financial-it’s human.