When a brand-name drug company gets its medicine approved by the FDA, it doesn’t mean generics can rush in right away. Even after the patent expires, a 30-month stay can block generic versions from hitting the market - not because the patent is still valid, but because of a lawsuit. This isn’t a glitch. It’s part of the system. And it’s costing Americans billions every year.
What Is the 30-Month Stay?
The 30-month stay is a rule built into the Hatch-Waxman Act of 1984. It was designed to balance two goals: letting generic drug makers enter the market quickly, while giving brand-name companies time to defend their patents. Here’s how it works: when a generic company files an application to sell a cheaper version of a drug, they must declare whether they believe the existing patents are invalid or won’t be infringed. That’s called a Paragraph IV certification. If the brand-name company sues them for patent infringement within 45 days, the FDA is legally forced to hold off on approving the generic - for up to 30 months.
That’s not a deadline for the court to decide. It’s a clock the FDA has to stop. Even if the lawsuit is clearly weak, the stay kicks in automatically. And if the case drags on past 30 months, the FDA can’t approve the generic until the court rules - unless the judge ends the stay early. Most of the time, it doesn’t.
How It Delays Generic Drugs
People assume the 30-month stay means generics come out 30 months after the lawsuit starts. But that’s not how it plays out in real life. The median time between when a brand drug launches and when a generic challenges its patent is 5.2 years. The 30-month stay starts after that. Then, even after the stay ends, most generics don’t launch right away. On average, there’s another 3.2 years before the cheaper version hits shelves.
Why? Because the real delay isn’t the legal clock. It’s the strategy. Brand companies often file multiple patents - not just on the active ingredient, but on the pill coating, the dosage form, even the way it’s taken. Some of these patents come years after the original approval. The FDA lists them in the Orange Book, and each one can trigger a new 30-month stay. The 2003 Medicare law stopped companies from filing multiple stays for the same generic applicant, but they still find ways to stretch out the game.
A 2019 Brookings study found that 67% of patents listed for top-selling drugs were filed after the drug first got approved. That’s not innovation. That’s delay.
Tentative Approval Doesn’t Mean You Can Buy It
Here’s something most people don’t know: the FDA can give a generic drug tentative approval during the 30-month stay. That means the agency has reviewed the science, checked the manufacturing, and says, “This is safe and works.” But they can’t let it hit the market yet. In 2022, the FDA gave tentative approval to 78% of ANDAs still in litigation. That’s over 800 drugs cleared to sell - but stuck in legal limbo.
On average, it takes 11.3 months after tentative approval for the drug to finally launch. That’s not because of paperwork. It’s because the generic company is waiting for the legal cloud to lift. Sometimes, they’re even waiting for the brand company to drop the suit - or settle.
Settlements That Delay Competition
Here’s the dirty secret: most of these lawsuits never go to trial. About 78% end in settlements, according to the FTC. And too often, those settlements include deals where the brand company pays the generic maker to stay off the market. These are called “pay-for-delay” agreements. The generic gets paid millions to wait. The brand keeps its high prices. Patients pay more.
The FTC called these deals “anti-competitive.” In 2021, patent litigation delays added $13.9 billion to U.S. drug costs. That’s not a rounding error. That’s the cost of 13 million insulin prescriptions, or 50 million asthma inhalers, or enough to cover the entire annual drug bill for 2.5 million Medicare beneficiaries.
Who Wins? Who Loses?
Brand-name companies say the 30-month stay is necessary to protect innovation. Scott Gottlieb, former FDA commissioner, argues it’s helped bring over 12,000 generics to market and saved consumers $2.2 trillion since 1984. That’s true. But those savings come from generics that actually launch - not the ones stuck in litigation.
Harvard’s Dr. Aaron Kesselheim says the system is being abused. “The 30-month stay has become a tool to systematically delay competition,” he wrote in JAMA. His research shows it adds an average of 1.8 extra years to a drug’s monopoly. That’s not protecting R&D. That’s gaming the clock.
Generic companies aren’t innocent either. Preparing for a lawsuit costs $3 to $5 million per drug, according to a 2022 survey. That’s why only the biggest players - Teva, Viatris, Sandoz - can afford to challenge patents. Smaller firms walk away. The result? Less competition, fewer price drops.
What’s Changing?
The system is under fire. 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 the same idea, pointing out that brand companies now list an average of 8.3 patents per drug - up from 1.2 in 1995.
The FDA is also stepping in. Its 2023 draft guidance wants stricter rules on what patents get listed in the Orange Book. No more listing patents on packaging or useless formulations. If the patent doesn’t directly protect the drug’s active ingredient, it shouldn’t trigger a stay.
Industry analysts predict these changes could speed up generic entry for $78 billion worth of drugs set to lose patent protection by 2028. That could save consumers $195 billion.
Why This Matters to You
If you take a prescription drug, you’re already feeling the impact. The average price drop after a generic launches is 80 to 85%. But if that generic is delayed by two years because of a lawsuit, you’re paying brand prices for 24 extra months. For a $1,000-a-month drug, that’s $24,000 extra in your pocket - or your insurer’s.
It’s not just about cost. It’s about access. People skip doses. They ration pills. They choose between meds and groceries. Every month the 30-month stay drags on, someone’s health is on the line.
The Hatch-Waxman Act was meant to be a fair compromise. But 40 years later, it’s a tool for delay. The system works - for lawyers, for big pharma, for patent trolls. It doesn’t work for patients.
Change is coming. But until then, the 30-month stay remains the biggest roadblock between a cheap drug and the person who needs it.
What triggers a 30-month stay?
A 30-month stay is triggered when a generic drug company files a Paragraph IV certification challenging a patent listed in the FDA’s Orange Book, and the brand-name drug manufacturer files a patent infringement lawsuit within 45 days of receiving notice. The FDA must then pause final approval of the generic for up to 30 months.
Can the FDA approve a generic during the 30-month stay?
No, the FDA cannot give final approval during the 30-month stay. But it can issue tentative approval, which means the drug meets all scientific and manufacturing requirements. Final approval only happens after the stay ends - either after 30 months, a court ruling, or a settlement.
Do all patent lawsuits trigger a 30-month stay?
Only lawsuits based on patents listed in the FDA’s Orange Book and challenged by a Paragraph IV certification trigger the stay. Patents not listed in the Orange Book, or those filed after the original drug approval, typically don’t qualify - unless they’re added later and meet FDA criteria.
How long does the 30-month stay actually delay a generic drug?
The 30-month stay itself lasts up to 30 months, but the total delay is often longer. On average, generics launch 3.2 years after the stay ends due to commercial delays, settlement terms, or additional litigation. The FTC estimates the total delay from patent challenge to generic launch is about 26 months on average.
Are there efforts to change the 30-month stay?
Yes. In 2023, Congress introduced legislation to reduce the stay to 18 months and ban it for secondary patents. The FTC and FDA are also pushing for stricter rules on patent listings in the Orange Book. Industry analysts predict major reforms within five years, especially as bipartisan pressure grows to lower drug prices.
Joel Deang
December 3, 2025 AT 17:47