Recent Patent Cases and Generic Delays: 2023-2025 Examples
Jan, 16 2026
It’s 2026. You walk into your pharmacy to refill your prescription for apixaban, the blood thinner. The pharmacist says, "It’s been approved by the FDA since last November. We just can’t get it." You’re confused. Approved means available, right? Not anymore. In the U.S., a drug can be cleared by regulators and still sit on a shelf for years because of patent fights no one talks about.
Why Approved Doesn’t Mean Available
The FDA approved 63 first generics in 2025. But only 18 of them reached pharmacies that year. The rest? Stuck. Not because they’re unsafe. Not because the manufacturing is flawed. But because brand-name drugmakers filed lawsuits to extend their monopoly. This isn’t a glitch. It’s the system. Under the Hatch-Waxman Act, when a generic company files an application and says a patent is invalid or won’t be infringed (a Paragraph IV certification), the brand company gets a 30-month automatic stay. That’s 30 months where the FDA can’t give final approval - even if the patent is weak or expired. In 2024, 68% of all generic applications included a Paragraph IV challenge. That’s nearly 7 out of 10. And the average number of patents listed on a single brand drug? 14.7. That’s up from 12.3 in 2020. These aren’t all strong patents. Many are minor tweaks - new dosages, packaging, or delivery methods - called "evergreening." But under current rules, each one triggers another 30-month clock.The Humira Effect: How One Drug Changed Everything
AbbVie’s Humira, a blockbuster autoimmune drug, is the poster child for this problem. Its core patent expired in 2016. But between 2016 and 2023, AbbVie filed over 240 patents related to Humira. Each one triggered a lawsuit when a biosimilar tried to enter. The result? No biosimilar reached the market until 2023 - seven years after the original patent expired. That’s not an outlier. It’s the new normal. A 2025 study found that the average time between FDA approval and market launch for generics is now 3.2 years. For complex drugs like injectables or inhalers, it’s closer to 4.1 years. In Europe, the same drugs hit shelves in 1.7 years. Why? Because they don’t have the same patent-stay system. Their courts move faster. Their regulators don’t get dragged into every lawsuit.Who Pays the Price?
Patients pay. Pharmacists pay. The system pays. A 2025 survey by the Association for Accessible Medicines found 82% of pharmacists get asked daily: "Why is the generic not here?" The top drugs causing this frustration? Eliquis, Trulicity, Steglatro, Xarelto - all of them approved, none of them available. Patients are skipping doses or switching to cheaper, less effective drugs. Patients For Affordable Drugs Now documented 412 cases between 2023 and 2025 where people couldn’t afford the brand version because the generic was blocked. The average monthly cost for the brand? $487. The projected cost for the generic? $85. Hospitals are feeling it 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. One oncologist in Ohio told me: "We have a patient on a chemo drug. The generic is approved. We can’t get it. We’re using the brand. It’s $12,000 a month. Insurance won’t cover it all. The patient is crying in my office because she can’t afford to live. The patent is the reason. Not the science. Not the supply chain. The patent."
Why the FDA Can’t Fix This
The FDA approves drugs. That’s their job. But they don’t control patents. That’s the courts. So even if the FDA says, "This generic is safe and effective," they’re legally blocked from letting it sell if a lawsuit is active. In 2025, the FDA’s Center for Drug Evaluation and Research admitted this in a congressional hearing. Dr. Patrizia Cavazzoni said: "Patent litigation remains outside our regulatory authority." She added they’re trying to make patent listings in the Orange Book more accurate - to stop companies from listing weak patents. But that’s a band-aid. It doesn’t touch the 30-month stay. The FDA’s new AI tools helped cut review times by 22% for non-litigated generics. That’s good. But for the 68% of applications tied to patent fights? No change. The clock still ticks for 30 months.Supply Chains Aren’t the Real Problem
You hear a lot about supply chain issues. And yes, 37% of delayed generics in 2023-2025 had API shortages. But that’s not the main cause. Patent litigation is responsible for 72% of delays. For complex generics like injectables? 89% of delays are patent-related. Companies like Teva and Sandoz are responding. They’ve increased their number of approved API suppliers from 1.8 in 2022 to 3.4 in 2025. That helps. But if a patent lawsuit blocks them from selling, having more suppliers doesn’t matter.The Cost of Delay
The financial toll is staggering. The top 10 drugs losing exclusivity in 2025 had $78.3 billion in annual sales. That’s billions in profits protected by lawsuits, not innovation. The Congressional Budget Office estimated that patent delays cost Medicare Part D $3.2 billion in 2025 alone. That’s money that could have gone to insulin, cancer drugs, or mental health care. Generic manufacturers are spending $12.7 million per case on legal fees in 2025 - up from $9.3 million in 2023. Small companies can’t afford this. 63% of delayed generics come from firms with under $500 million in revenue. Big players like Teva or Sandoz can fight. Smaller ones? They fold. Or they never file.
What’s Changing?
There are signs of pressure. The FTC filed seven enforcement actions between 2024 and 2025 against companies using "patent thicketing" - like Jazz Pharmaceuticals, which settled over Xyrem by agreeing to let generics enter earlier. The CREATES Act, designed to let generics get samples for testing without being blocked by brand companies, passed the House in 2024 but stalled in the Senate in 2025. The FDA’s new Commissioner, Dr. Peter Bach, is pushing for more transparency in patent listings. Industry analysts predict this could cut generic entry time by 8-12 months by 2027. But that’s still years away. And it doesn’t fix the 30-month stay.What Comes Next?
The system is broken. It was designed to balance innovation and access. Now, it’s being used to delay access for profit. There are three real paths forward:- Limit patent listings: Cap the number of patents per drug. Right now, there’s no limit. One drug has 14 patents. That’s not innovation. That’s obstruction.
- Shorten the 30-month stay: Reduce it to 12 months. That’s still enough time for courts to rule. But it stops companies from gaming the system.
- Let the FDA act: Give the FDA authority to override patent stays if a patent is clearly weak or invalid - like a new dosage on an expired compound.
What You Can Do
If you’re a patient: Ask your pharmacist why the generic isn’t available. Write to your representative. Tell them you’re paying $400 a month for a drug that should cost $80. If you’re a provider: Document cases where patients can’t get generics. Report them to Patients For Affordable Drugs Now or the ASHP. Data drives change. If you’re in the industry: Push for reform. Don’t wait for Congress. Start with your company’s policy. Don’t file weak patents. Don’t delay generics. The public sees what you’re doing. The patent system was meant to protect inventors. Not to lock patients out of affordable medicine. It’s time we fixed it.Why is a generic drug approved but not available in pharmacies?
A generic drug can be approved by the FDA but still blocked from sale if the brand-name manufacturer files a patent lawsuit. Under the Hatch-Waxman Act, this triggers a 30-month automatic stay, preventing the FDA from granting final approval - even if the patent is weak or expired. This legal delay can last years, while the drug sits on a shelf.
What is a Paragraph IV certification?
A Paragraph IV certification is a legal statement filed by a generic drugmaker when applying to the FDA. It says that a brand-name drug’s patent is either invalid or won’t be infringed by the generic version. This triggers a patent lawsuit from the brand company, which then starts the 30-month stay that delays generic market entry.
How long do patent delays typically last for generic drugs?
The average delay between FDA approval and market launch for generics is 3.2 years. For complex drugs like injectables or inhalers, delays can stretch to 4.1 years. This is mostly due to patent litigation, not manufacturing or regulatory issues.
Why are oncology drugs especially affected by patent delays?
Oncology drugs are often complex, expensive, and have multiple patents listed per product. Brand manufacturers aggressively defend them because they’re high-revenue drugs. As a result, the average delay for generic oncology drugs is 4.1 years - longer than any other therapeutic category. Many of these delays are caused by patent thickets - dozens of minor patents layered over the core invention.
Is the FDA doing anything to fix patent delays?
The FDA can’t directly stop patent delays because patent law is handled by courts, not regulators. But they are improving transparency in the Orange Book - the list of patents for brand drugs - to prevent improper listings. They’ve also introduced AI tools to speed up reviews for non-litigated applications. However, the 30-month stay remains untouched, and the agency has no power to override patent lawsuits.
What’s the difference between a generic and a biosimilar?
A generic is a chemically identical copy of a small-molecule drug, like a pill. A biosimilar is a highly similar version of a complex biological drug, like Humira or Enbrel. Biosimilars face even more complex patent battles - with an average of 9.7 patents challenged per application in 2025, up from 5.2 in 2020. They also take longer to develop and approve, but their market entry is accelerating, with 17 approved by Q3 2025.
How do patent delays affect Medicare costs?
Patent delays cost Medicare Part D an estimated $3.2 billion in 2025. This is because patients are forced to use expensive brand-name drugs instead of cheaper generics. The Congressional Budget Office found that if generics entered the market on time, Medicare would save billions annually - money that could fund other essential treatments.
Are patent delays happening in other countries?
Yes, but not as severely. In Europe, the average time between generic approval and market launch is 1.7 years - less than half the U.S. average. That’s because European countries don’t have a 30-month automatic stay. Their patent systems are faster, and courts don’t allow the same level of patent thicketing. The U.S. system is uniquely designed to favor brand manufacturers.
What’s the CREATES Act and why does it matter?
The CREATES Act would require brand-name companies to provide samples of their drugs to generic manufacturers so they can test and develop their versions. Right now, some brands refuse to sell samples, blocking generic development. The House passed the bill in 2024, but it stalled in the Senate in 2025. If passed, it would remove one barrier to generic entry - but it doesn’t fix patent lawsuits or the 30-month stay.
Can small generic companies compete with big pharma in patent battles?
It’s getting harder. Legal costs for patent litigation hit $12.7 million per case in 2025. 63% of delayed generics come from companies with under $500 million in annual revenue. Big companies like Teva or Sandoz can afford to fight. Smaller ones often can’t - so they drop their applications or sell out. This reduces competition and keeps prices high.