Why Approved Generic Drugs Still Aren’t on Shelves
Imagine your doctor prescribes a generic version of a popular medication-say, Eliquis or Xarelto-and you walk into the pharmacy expecting to pay a fraction of the brand-name price. But when you ask for it, the pharmacist says, "It’s been approved by the FDA since last November. We just can’t get it." This isn’t a glitch. It’s the new normal in U.S. pharmaceuticals.
From 2023 to 2025, the FDA approved 63 first generics that still hadn’t reached patients by the end of 2025. Why? Because even after the FDA says a drug is safe and effective, patent lawsuits can lock it out of the market for years. The system meant to speed up affordable medicine is now being used to delay it.
The 30-Month Stay: A Legal Lockout
The heart of the problem lies in the Hatch-Waxman Act, a 1984 law designed to balance innovation and access. It lets generic manufacturers challenge brand-name patents by filing what’s called a Paragraph IV certification. This triggers a 30-month automatic stay that blocks the FDA from giving final approval.
That sounds fair-until you realize that in 68% of generic applications in 2024, the generic company challenged at least one patent. And the average drug now has 14.7 patents listed in the FDA’s Orange Book, up from 12.3 in 2020. Brand companies don’t just defend one patent. They file dozens, sometimes on minor changes like coating thickness or tablet shape. Each one resets the clock.
It’s not about whether the patent is valid. It’s about time. The 30-month stay isn’t a court decision-it’s a legal pause button. And brand-name companies press it again and again.
Patent Thicketing: The Real Game
Dr. Aaron Kesselheim of Harvard Medical School put it plainly: "Originator companies have extended monopolies beyond the 20-year patent term by an average of 3.7 years per drug." That’s not a fluke. It’s strategy.
Take Humira. Its core patent expired in 2016. But AbbVie filed over 240 patents related to it, creating what experts call a "patent thicket." By the time the first biosimilar finally launched in 2023, the company had protected its market for 10 years past the original patent expiry.
This isn’t rare. In 2025, the average number of patents challenged per biosimilar application jumped to 9.7, up from 5.2 in 2020. The goal isn’t to win every lawsuit. It’s to drag out the process until the generic company runs out of money-or the brand’s patent portfolio is so thick that no one dares to challenge it.
Who Gets Hurt? Patients and Pharmacies
The cost isn’t just financial. It’s human.
A 2025 survey by Patients For Affordable Drugs Now found 412 documented cases between January 2023 and September 2025 where patients skipped doses or stopped taking their meds because the generic wasn’t available. The brand-name versions cost an average of $487 per month. The generics? They should’ve been around $85.
Pharmacists are on the front lines. One pharmacist on Drugs.com wrote: "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."
According to the American Society of Health-System Pharmacists, 78% of hospital pharmacy directors say patent delays are a "major contributor" to drug shortages-especially for cancer drugs. In oncology, the average delay between FDA approval and market launch is 4.1 years. That’s longer than most PhD programs.
Why the FDA Can’t Fix This
The FDA approves drugs. But it doesn’t decide patent disputes. That’s the courts. And the agency has no power to override a 30-month stay-even if it knows the patent is weak.
Dr. Patrizia Cavazzoni, FDA’s CDER Director, admitted in May 2025: "Patent litigation remains outside our regulatory authority." She’s right. But she also said the agency is trying to make patent listings in the Orange Book more accurate to stop "evergreening." That’s a start-but it’s like trying to stop a flood with a sponge.
The FDA’s new AI review system cut approval times by 22% for drugs without patent fights. But for those with litigation? No change. The 30-month stay still rules.
Supply Chains and Complex Drugs Make It Worse
It’s not just patents. Complex generics-like injectables, inhalers, and biologics-are harder to make. And their supply chains are fragile.
Between 2023 and 2025, 37% of delayed generic launches cited problems getting the active pharmaceutical ingredient (API). Most of these were injectables. One oncology drug shortage was tied to a single supplier in India shutting down for regulatory reasons.
Companies like Teva and Sandoz have responded by increasing their approved API suppliers from 1.8 on average in 2022 to 3.4 in 2025. That’s smart. But it’s expensive. And it doesn’t help if the patent lawsuits keep the drug off the market anyway.
U.S. vs. Europe: The Gap Is Growing
While the U.S. drags its feet, Europe moves faster. In the EU, the average time between generic approval and market launch is 1.7 years. In the U.S., it’s 3.2 years.
Why? Europe doesn’t have the same patent linkage system. If a generic is approved, it can launch unless a court rules the patent is valid. No automatic 30-month hold. No endless patent stacking.
And it shows in prices. A 2024 IQVIA report found that generic prices in Europe drop 50% faster after market entry than in the U.S.
What’s Being Done? Not Enough
There’s been talk. The FTC filed 7 enforcement actions between 2024 and 2025 against companies using "pay-for-delay" deals or patent thicketing. One case against Jazz Pharmaceuticals over Xyrem ended in a settlement requiring earlier generic entry.
The CREATES Act, meant to help generic companies get samples for testing, stalled in Congress in 2025. The FDA’s new priority voucher program speeds up reviews-but only for non-patent cases.
And the real blocker? Money. The average cost of patent litigation for a generic company hit $12.7 million per case in 2025. That’s more than most small generic firms make in a year. So they don’t fight. They wait.
What’s Next? The Future Is Unclear
The top 10 drugs losing exclusivity in 2025 had $78.3 billion in annual sales. That’s a lot of profit to protect. And the brand companies are spending billions to do it.
McKinsey found that 67% of industry stakeholders support limiting the number of patents per drug. But PhRMA, the drug industry lobby, says that would "undermine innovation." They’re right that innovation matters. But not when innovation means filing 15 patents on a pill to keep prices high.
With Dr. Peter Bach as FDA Commissioner since January 2025, there’s hope for more transparency. But real change will need Congress to fix the Hatch-Waxman Act-not just tweak the rules.
Final Thought: Approval Isn’t Access
Having a drug approved by the FDA doesn’t mean it’s available. The system was built to balance innovation and access. Today, it’s tilted hard toward the former.
Patients are paying more. Pharmacies are frustrated. Hospitals are rationing. And the companies that make affordable drugs? They’re being priced out of the game.
Until patent lawsuits stop being a tool to delay competition-not defend it-the promise of generic medicine will keep being broken.
