Health November 20, 2025
30-Month Stay: How Patent Litigation Delays Generic Drug Approval
When a brand-name drug company gets FDA approval, it doesn’t mean the drug will stay exclusive forever. But in the U.S., there’s a powerful legal tool that can block generics for years - even after the patent expires. It’s called the 30-month stay, and it’s not a bug in the system. It’s the system.
What Is the 30-Month Stay?
The 30-month stay is part of the Hatch-Waxman Act, passed in 1984. It was meant to balance two goals: letting generic drugs reach the market faster, while still protecting the innovation that made those drugs possible. Here’s how it works in practice.A generic drug maker files an application with the FDA to sell a cheaper version of a brand-name drug. But if they claim the brand’s patent is invalid or won’t be infringed - known as a Paragraph IV certification - the brand company gets 45 days to sue for patent infringement. If they do, the FDA is legally blocked from approving the generic for up to 30 months. That’s the stay.
It doesn’t stop the FDA from reviewing the application. They can give a tentative approval during this time. But they can’t give the final green light. The clock only starts ticking after the brand company files suit. And if the lawsuit drags on past 30 months? The stay can extend - unless a court says otherwise.
Why Does This Matter?
The 30-month stay isn’t just paperwork. It’s a financial firewall. In 2022, the FDA received 1,046 generic drug applications. Nearly 80% of them were stuck in this legal limbo. That means thousands of patients couldn’t get cheaper versions of their meds - not because the drugs weren’t safe, but because lawyers were still arguing in court.Take a drug like Humira. When its main patent expired, the brand company filed dozens of secondary patents - on packaging, dosing methods, even how it’s administered. Each one triggered a new legal round. The result? Generic versions didn’t hit the market for over a decade after the original patent expired.
This isn’t rare. A 2019 Brookings study found that 67% of patents listed for top-selling drugs were filed after the original approval. These aren’t new inventions. They’re tweaks. But under Hatch-Waxman, they still trigger the 30-month stay.
Who Wins? Who Loses?
Brand-name companies say the stay is essential. Without it, they argue, no one would invest in new drugs. Scott Gottlieb, former FDA commissioner, says Hatch-Waxman has saved consumers $2.2 trillion since 1984 by enabling over 12,000 generic approvals. That’s true - but it ignores the cost of delay.The FTC estimates that patent litigation delays caused by the 30-month stay add $13.9 billion to U.S. drug costs every year. That’s not just corporate profit. It’s out-of-pocket costs for seniors, higher insurance premiums, and rationing by patients who can’t afford their meds.
On the other side, generic manufacturers spend $3-5 million per drug just on legal fees. A 2022 survey found 78% of them said preparing for litigation adds 6-9 months to their development timeline. That’s not just money. It’s time they could’ve spent testing, manufacturing, and getting drugs to patients.
The First-Mover Advantage
There’s one twist that makes this game even more intense: the 180-day exclusivity period for the first generic company to successfully challenge a patent. That’s a huge reward. If you’re first, you get to be the only generic on the market for half a year - no competition, full pricing power.That’s why companies race to file. In 2022, 72% of drugs faced multiple Paragraph IV challenges. But only one gets the prize. The rest? They’re left waiting - sometimes for years - while the first filer takes the market.
Ironically, having multiple challengers actually speeds things up. Drugs with more than one filer get approved 8.2 months faster on average. The competition forces quicker legal resolutions. But if one company settles with the brand, the others get stuck. That’s called a “pay-for-delay” deal - and it’s still common.
What’s Happening Now?
The system is under pressure. In 2023, Congress introduced the Affordable Prescriptions for Patients Act. It proposes cutting the 30-month stay to 18 months and banning stays for secondary patents. The FTC is pushing for the same. They found that brand companies now list an average of 8.3 patents per drug - up from just 1.2 in 1995.The FDA is also stepping in. Their 2023 draft guidance wants more transparency in the Orange Book - the list of patents linked to brand drugs. Right now, companies can list patents that are vague, expired, or irrelevant. That creates unnecessary stays. If the FDA forces clearer listings, fewer frivolous lawsuits will trigger the 30-month block.
Meanwhile, the market is shifting. Biologics - complex drugs like insulin or cancer treatments - aren’t covered by Hatch-Waxman. They have their own 12-year exclusivity under the BPCIA. And biosimilars (the generic version of biologics) are growing fast. By 2028, they could make up 12% of the biologics market. That’s a new path to lower prices - one that doesn’t rely on the 30-month stay.
The Real Delay Isn’t the 30 Months
Here’s something most people miss: the 30-month stay rarely lasts the full 30 months. In fact, a 2021 study found that the median time between stay expiration and actual generic launch is 3.2 years. So what’s causing the real delay?It’s not the law. It’s commercial readiness. Companies don’t launch the moment they get approval. They wait for manufacturing capacity. They wait for distribution deals. They wait to see if their competitor will settle. Sometimes, they wait because the brand company is still fighting other patents.
One Teva regulatory specialist put it bluntly on a pharma forum: “The 30-month stay creates false security. The real delay is internal.”
What’s Next?
By 2028, over $78 billion in brand-name drugs will lose patent protection. If the 30-month stay stays unchanged, consumers will pay billions more than they should. If reforms pass - cutting the stay, banning secondary patents, increasing transparency - those savings could reach $195 billion.But change won’t come easy. The pharmaceutical industry spent over $100 million lobbying Congress in 2023. They argue that any change will hurt innovation. But the data tells a different story: the U.S. spends more on drugs than any other country - and still lags in generic access.
The 30-month stay was never meant to be a decades-long delay tactic. It was a temporary pause - a fair trade for innovation. Today, it’s become a permanent roadblock. And patients are the ones paying the toll.
What triggers the 30-month stay?
The 30-month stay is triggered when a generic drug manufacturer files a Paragraph IV certification challenging a patent listed in the FDA’s Orange Book, and the brand-name company files a patent infringement lawsuit within 45 days of being notified. The FDA then cannot approve the generic for up to 30 months, or until the court rules in favor of the generic, whichever comes first.
Does the 30-month stay always last 30 months?
No. The stay ends early if the court rules the patent is invalid or not infringed. It can also be extended if the litigation is unresolved and the FDA determines the delay is due to the generic applicant’s actions. But it rarely lasts the full 30 months - the average time between stay expiration and actual generic launch is 3.2 years, meaning other factors cause most delays.
Can a brand company trigger multiple 30-month stays?
No. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) limits brand companies to one 30-month stay per ANDA filer. They can’t file multiple lawsuits over different patents to extend the delay beyond one 30-month period for the same generic applicant.
What is tentative approval?
Tentative approval means the FDA has reviewed the generic drug application and found it scientifically acceptable, but approval is on hold due to patent litigation or exclusivity. Once the 30-month stay ends or the patent is invalidated, tentative approval becomes final, and the drug can be marketed immediately.
Why do generic companies still file Paragraph IV certifications if the process is so slow?
Because the first company to successfully challenge a patent gets 180 days of market exclusivity - no other generics can enter during that time. That’s a massive financial incentive. Even with legal costs and delays, the potential profit from being first can be hundreds of millions of dollars.
Are biosimilars affected by the 30-month stay?
No. Biosimilars are regulated under the Biologics Price Competition and Innovation Act (BPCIA), which has a different framework. It provides 12 years of data exclusivity but does not include a 30-month stay mechanism. Patent disputes for biosimilars are handled through separate legal procedures, without automatic FDA approval delays.
