Recent Patent Cases and Generic Delays: 2023-2025 Examples

By 2025, thousands of patients in the U.S. were still paying full price for brand-name drugs-even though the FDA had already approved cheaper generic versions. The reason? Patent litigation was holding up launches longer than ever before. It wasn’t a glitch. It wasn’t bad luck. It was a system designed to delay competition, even when the patents were weak or expired.

Why Approved Doesn’t Mean Available

The FDA approved 63 first generics in 2025. That sounds like progress. But here’s the catch: the average time between FDA approval and actual market availability was 3.2 years. That’s not a typo. It’s not a delay. It’s a freeze. Patients with diabetes, heart disease, or cancer were stuck with $487 monthly bills for brand drugs when generics should’ve cost $85. Pharmacists were getting the same question over and over: “Why is the generic approved but not in stock?”

The answer lies in the Hatch-Waxman Act’s 30-month stay. When a generic company files an ANDA with a Paragraph IV certification-meaning they say a patent is invalid or won’t be infringed-the brand-name company can sue. That lawsuit triggers a 30-month clock. The FDA can’t give final approval until that clock runs out, even if the court rules in favor of the generic. In 2024, 68% of all generic applications included this kind of patent challenge. In 2025, the average drug had 14.7 patents listed in the Orange Book. That’s up from 12.3 in 2020. More patents. More lawsuits. More delays.

The Humira Effect: How One Drug Changed the Game

AbbVie’s Humira didn’t just dominate the market-it rewrote the rules. The basic patent expired in 2016. But AbbVie filed over 240 patents around it, creating a legal thicket so thick that no generic could enter until 2023. Even then, it took years of court battles. This became the playbook. Companies started stacking patents like bricks: method-of-use, formulation, manufacturing process, packaging. Each one could trigger a new 30-month stay. Dr. Aaron Kesselheim of Harvard called it “extending monopolies beyond the 20-year term by an average of 3.7 years per drug.”

The result? Oncology drugs faced the longest delays-4.1 years on average. Cardiovascular generics took 2.8 years. Simple oral pills? Still 2.3 years. Meanwhile, in Europe, where patent laws don’t allow the same kind of litigation stacking, generics hit the market in just 1.7 years after approval.

Complex Generics Get Hit Hardest

It’s not just about pills. Injectables, inhalers, and complex formulations face even tougher hurdles. In 2025, 89% of delayed complex generics were blocked by patent litigation. Compare that to 63% of simple oral solids. Why? Because complex generics require more testing, more manufacturing precision, and more patent scrutiny. But the real problem? Supply chains.

Thirty-seven percent of delayed generic launches between 2023 and 2025 were tied to shortages of active pharmaceutical ingredients (APIs). Many of these came from India and China. When geopolitical tensions or factory inspections disrupted supply, even approved generics couldn’t be made. Fourteen of the 15 oncology drugs with shortages during that period were injectables. Hospitals were forced to ration. Patients missed treatments. And the FDA? They could approve the drug-but couldn’t fix the factory.

Who Pays the Price?

The financial toll is staggering. The top 10 drugs losing exclusivity in 2025 represented $78.3 billion in annual brand sales. Stelara, Dupixent, Prolia-each one could’ve saved Medicare Part D hundreds of millions if generics had launched on time. The Congressional Budget Office estimated patent delays cost Medicare $3.2 billion in 2025 alone.

Small generic companies got crushed. Sixty-three percent of delayed generics came from manufacturers with less than $500 million in annual revenue. Legal fees averaged $12.7 million per case in 2025-up from $9.3 million in 2023. Most couldn’t afford to fight. Bigger players like Teva and Sandoz could. They diversified their API suppliers from 1.8 on average in 2022 to 3.4 by 2025. They hired teams of patent lawyers. They filed citizen petitions to challenge improper listings. But even then, the FDA took 18.2 months on average to respond.

The FDA’s Hands Are Tied

The FDA can approve a drug. They can inspect a factory. They can fast-track reviews with AI tools that cut review times by 22% for non-litigated cases. But they can’t touch patent law. Dr. Patrizia Cavazzoni, director of the FDA’s drug center, admitted in May 2025: “Patent litigation remains outside our regulatory authority.”

That’s why the agency started pushing for transparency. They began cleaning up the Orange Book, removing patents that didn’t clearly relate to the drug’s use. They also launched the National Priority Voucher program to speed up reviews-but again, it didn’t help when a lawsuit was active. The 30-month stay remained the iron gate.

In 2025, the FTC filed seven enforcement actions against companies using “patent thicketing” to block competition. One case against Jazz Pharmaceuticals over Xyrem led to a settlement forcing earlier generic entry. But these are rare exceptions. Most cases drag on for years.

What’s Changing in 2025-2026?

There are signs of pressure. The CREATES Act, designed to let generics get samples of brand drugs for testing, stalled in Congress. But companies are adapting. Generic manufacturers now start patent research 48 to 60 months before expiration. They’re building legal teams before they even file an ANDA.

The rise of biosimilars is also shifting the landscape. Seventeen biosimilars were approved by Q3 2025, including ones targeting Humira. But each one now faces an average of 9.7 patents challenged-up from 5.2 in 2020. The same tactics are being copied.

And then there’s the public outcry. Patients For Affordable Drugs Now documented 412 cases where people skipped doses because generics weren’t available. Pharmacists reported patients crying in line, asking why their insulin still cost $300 when the FDA said a generic was approved two years ago.

What Can You Do?

If you’re a patient: Ask your pharmacist if a generic is approved but not available. If they say yes, ask why. Request a list of the brand-name drug’s patents from the FDA’s Orange Book. You might be surprised how many are weak or expired.

If you’re a prescriber: Know the difference between FDA approval and market availability. When a patient can’t get a generic, it’s not because there isn’t one. It’s because the system is broken.

If you’re in the industry: Diversify your supply chain. Build legal readiness early. Track patent expirations like a clock. The window to enter is shrinking.

Is There Hope?

Yes. But it’s slow. The new FDA Commissioner, Dr. Peter Bach, has signaled he’ll push for faster Orange Book updates and stricter rules on patent listings. If implemented, this could cut generic delays by 8 to 12 months by 2027. But it won’t fix the core problem: the law lets companies use patents as shields, not just protections.

The system was meant to balance innovation and access. Today, it’s tilted hard toward delay. Until Congress rewrites the rules-or the courts start striking down patent thickets-patients will keep paying more, waiting longer, and wondering why the system that’s supposed to help them is working against them.