Recent Patent Cases and Generic Delays: 2023-2025 Examples

It’s 2025, and you walk into your local pharmacy asking for the generic version of your expensive prescription. The pharmacist shakes their head. "It’s been approved by the FDA since last November," they say. "But we still can’t get it." This isn’t rare. It’s the new normal.

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 is now 3.2 years. That’s not a typo. That’s the reality for hundreds of drugs. Even when a generic drug passes every safety and quality check, it can sit on a shelf-legally blocked-from reaching patients.

The main reason? Patent litigation. Brand-name drug companies file lawsuits against generic manufacturers the moment they file for approval under a Paragraph IV certification. This triggers a 30-month automatic stay, halting the FDA from giving final approval. It doesn’t matter if the patent is weak, outdated, or even questionable. The clock starts anyway. And in 2024, 68% of all generic applications included this kind of patent challenge.

The Patent Thicket Problem

It’s not just one patent anymore. It’s dozens. The average number of patents listed per brand drug in the FDA’s Orange Book jumped from 12.3 in 2020 to 14.7 in 2025. Some drugs, like AbbVie’s Humira, have been wrapped in over 200 patents. These aren’t all groundbreaking inventions. Many are minor tweaks-new dosages, packaging, or delivery methods-designed to extend exclusivity. This tactic, called patent thicketing, has become standard practice.

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 over three years of patients paying full price because of legal maneuvering, not innovation.

Who Gets Hit the Hardest?

Not all drugs face the same delays. Complex generics-like injectables, inhalers, and biosimilars-are the worst off. For oncology drugs, the average delay between approval and launch is 4.1 years. Cardiovascular generics? 2.8 years. Simple oral pills? Closer to 2.3 years.

Why? Because complex drugs are harder to copy. They require more testing. And brand companies know that. So they pile on more patents, knowing it will take longer-and cost more-for a generic maker to fight back.

Small generic companies are especially vulnerable. In 63% of delayed cases, the manufacturer earns less than $500 million a year. Legal fees for a single patent case now average $12.7 million. For a small firm, that’s a gamble they can’t afford. Many just walk away.

The Supply Chain Complication

Patents aren’t the only problem. Supply chain issues are making things worse. In 37% of delayed generic launches between 2023 and 2025, the issue wasn’t legal-it was missing active ingredients. Especially for injectables, the API (active pharmaceutical ingredient) often comes from just one or two overseas suppliers. If there’s a disruption-political, logistical, or quality-related-the whole launch gets pushed back.

Companies like Teva and Sandoz are trying to fix this. In 2022, they had an average of 1.8 approved API suppliers. By 2025, that number rose to 3.4. More suppliers mean less risk. But it takes years to build those relationships. Most generics still operate on thin margins. Diversifying supply isn’t cheap.

What’s the FDA Doing?

The FDA has no power to override patent lawsuits. That’s the law. But they’ve tried to help. Their AI-assisted review system, rolled out in early 2025, cut approval times by 22% for non-litigated applications. That’s good news-for the 28% of generics that aren’t caught in court.

They’ve also started cleaning up the Orange Book. In May 2025, FDA Director Dr. Patrizia Cavazzoni admitted that improper patent listings have been used to block competition unfairly. The agency is now pushing for stricter rules on what patents can be listed. No more “method of use” patents for drugs already off-patent. No more listing patents that don’t actually cover the drug.

But change is slow. The FDA’s Citizen Petition process-meant to challenge bad patents-now takes an average of 18.2 months to resolve. That’s longer than the review time for most drugs.

Patients Are Paying the Price

Real people are suffering. A September 2025 survey by the Association for Accessible Medicines found that 82% of pharmacists get asked daily about approved but unavailable generics. The top drugs? Eliquis, Trulicity, Steglatro-each costing over $400 a month. The generic version? Around $85.

Patients For Affordable Drugs Now documented 412 cases between 2023 and 2025 where people skipped doses or stopped treatment because they couldn’t afford the brand. One man with diabetes rationed his insulin. A woman with rheumatoid arthritis used leftover samples from two years ago. These aren’t outliers. They’re symptoms of a broken system.

Hospital pharmacies report that patent delays are a leading cause of drug shortages. In 78% of cases, pharmacy directors say they’re forced to use more expensive alternatives-or go without.

Is There a Solution?

There are proposals. The CREATES Act, introduced in Congress in 2025, would force brand companies to provide samples to generic makers for testing. Right now, many refuse, claiming safety concerns. That’s a legal loophole that delays development by years.

The FTC has stepped in too. They’ve filed seven enforcement actions against companies using patent tactics to block competition. One case against Jazz Pharmaceuticals over Xyrem led to an agreement that let generics enter the market months earlier than planned.

But the biggest fix? Limiting how many patents a company can list per drug. Right now, there’s no cap. McKinsey found that 67% of industry stakeholders support a limit. The pharmaceutical lobby, PhRMA, says that would hurt innovation. But if the goal is to reward real innovation-not legal tricks-then change is overdue.

The Bigger Picture

The U.S. spends $3.2 billion extra every year on brand-name drugs that could be generic, thanks to patent delays. That’s Medicare money. That’s taxpayer money. That’s money families lose out on.

Meanwhile, Europe moves faster. The average time from approval to market there? Just 1.7 years. Why? Because their patent system doesn’t let lawsuits automatically pause everything. They resolve disputes faster. They don’t let patent thickets go unchecked.

The U.S. system was built to balance innovation and access. But today, it’s tilted hard toward protectionism. The 30-month stay was meant to be a pause, not a permanent wall. Now, it’s being used to delay competition for years-even when the patent is clearly invalid.

What Comes Next?

The top 10 drugs losing exclusivity in 2025 represent $78.3 billion in annual sales. That’s a massive opportunity for generics. But without reform, most of that money will stay with brand companies.

The new FDA Commissioner, Dr. Peter Bach, has signaled he wants more transparency. If he follows through-by forcing faster Orange Book updates, cracking down on bad patents, and supporting the CREATES Act-generic entry could speed up by 8 to 12 months by 2027.

But it won’t happen on its own. Patients, pharmacists, and providers need to keep asking: Why is this drug approved but not here? Why are we paying more because of a legal delay? The system won’t fix itself. Someone has to push it.