30-Month Stay: How Litigation Delays Generic Drug Approval

When a brand-name drug hits the market, it usually has a patent that protects it from competition for 20 years. But in the U.S., that clock doesn’t start ticking the day the patent is filed-it starts ticking the day the drug gets approved by the FDA. And even then, generic manufacturers can challenge that patent before it expires. That’s where the 30-month stay comes in. It’s not a delay caused by bureaucracy. It’s a legal pause, built into law, that can hold up a generic drug for years-even when the patent might not even be valid.

What Exactly Is the 30-Month Stay?

The 30-month stay is part of the Hatch-Waxman Act, passed in 1984. It was meant to strike a balance: let generic drugs come to market faster, but give brand companies time to defend their patents in court. Here’s how it works: when a generic company files an application to sell a cheaper version of a brand drug, they must say whether they believe the patents covering that drug are invalid or won’t be infringed. That’s called a Paragraph IV certification. If they do that, they have to notify the brand company. If the brand company sues for patent infringement within 45 days, the FDA is legally blocked from approving the generic drug for up to 30 months.

That’s it. No judge needs to rule. No hearing is required. The moment the lawsuit is filed, the clock starts. The FDA can still review the generic application, inspect the factory, and even give it tentative approval. But they can’t say yes-final approval is frozen until the 30 months are up, the patent is invalidated, or the court settles the case.

Why Does This Matter for Patients?

Think about a drug like Lipitor, which once brought in $13 billion a year. When its patent was set to expire, five generic companies filed Paragraph IV challenges. The brand company sued all of them. The 30-month stay kicked in for each case. Even though the patents were weak, the litigation dragged on. The first generic didn’t launch until 18 months after the patent expired. That’s $1.2 billion in extra revenue for the brand company-and billions more in higher costs for patients and insurers.

According to FDA data from 2022, 78% of ANDA applications received tentative approval during patent litigation. That means the FDA was ready to approve them. But they couldn’t. The delay wasn’t about safety or quality. It was about legal timing.

The FTC found that in 78% of Paragraph IV lawsuits, the brand and generic companies settled-not by fighting in court, but by agreeing to delay the generic’s launch. These deals, called "pay-for-delay," cost U.S. consumers an estimated $13.9 billion a year. The 30-month stay gives companies the perfect cover to make these deals. Why? Because the stay gives them a guaranteed window to negotiate without the pressure of immediate generic competition.

It’s Not Just 30 Months

The name says "30-month," but in practice, it often lasts longer. If the lawsuit isn’t resolved in 30 months, the stay doesn’t automatically end. The FDA can keep the approval on hold until the court rules. That means a generic could be stuck waiting for 36, 42, even 48 months. Meanwhile, the brand company keeps selling at full price.

And it gets worse. Some companies file multiple patents on minor changes-like a new pill coating or a slightly different dosage form-just to trigger new 30-month stays. A 2019 Brookings study found that 67% of patents listed for top-selling drugs were filed after the original drug approval. These aren’t breakthroughs. They’re legal tricks. And the system lets them work.

Who Benefits? Who Loses?

Brand companies love the 30-month stay. It gives them a predictable shield. Scott Gottlieb, former FDA commissioner, says it’s helped bring over 12,000 generics to market and saved consumers $2.2 trillion since 1984. That’s true. But he doesn’t mention the cost of the delays.

Generic manufacturers? They’re caught in a trap. They spend millions on legal teams just to file a challenge. A 2022 survey found 63% of generic companies spend $3-5 million per ANDA on litigation. And even if they win, they might not get to market right away. The first company to challenge a patent gets 180 days of exclusive rights to sell the generic. That’s a huge incentive. But it also means other companies wait, hoping to piggyback on the first mover’s legal victory. That creates a bottleneck. One company fights the battle. Everyone else waits.

Patients lose the most. A drug that could cost $50 a month as a generic might stay at $300 for two extra years because of a lawsuit that never even went to trial. For people with chronic conditions-diabetes, high blood pressure, asthma-that’s not a minor expense. It’s life or death.

How Does This Compare to Other Countries?

The U.S. is the only country that ties regulatory approval directly to patent litigation. In the European Union, generic companies can apply as soon as the patent expires. No lawsuits delay approval. Canada has a 24-month stay, but it’s shorter and less flexible. Australia and Japan have no such automatic stays at all.

The U.S. system is unique because it lets patent holders control the timing of generic entry-not the FDA, not the courts, but the threat of litigation. That’s not regulation. That’s leverage.

What’s Changing?

There’s growing pressure to fix this. In 2023, Congress introduced the Affordable Prescriptions for Patients Act, which would cap the 30-month stay at 18 months and ban stays for secondary patents. The FTC has been pushing for years to stop "patent thickets"-when companies list dozens of weak patents to block competition.

The FDA itself is taking steps. Its 2023 draft guidance wants brand companies to provide clearer, more accurate patent information in the Orange Book. If a patent doesn’t actually cover the drug’s active ingredient, it shouldn’t be listed. That would cut down on frivolous lawsuits.

But change is slow. The pharmaceutical industry spends billions lobbying against reform. PhRMA, the main brand drug lobby, argues that weakening the 30-month stay would hurt innovation. They say without it, companies wouldn’t invest in new drugs. But the data doesn’t back that up. Since 1984, drug R&D spending has more than tripled. And the U.S. still leads the world in new drug approvals.

What’s the Real Delay?

Here’s the truth: the 30-month stay isn’t the main reason generics are late. A 2021 study from USC found that, on average, there’s a 3.2-year gap between when the stay ends and when the generic actually launches. Why? Because companies wait. They wait to ramp up production. They wait to negotiate with insurers. They wait to see if the first filer’s 180-day exclusivity will be stripped.

So the 30-month stay isn’t always the villain. But it’s the enabler. It gives brand companies the time and cover to delay, negotiate, and protect profits-while patients wait.

What’s Next?

By 2028, over $78 billion in brand-name drug sales will lose patent protection. If the 30-month stay stays the same, we’ll see more delays, more settlements, more lost savings. But if Congress acts-capping the stay, banning secondary patents, cracking down on pay-for-delay deals-patients could save up to $195 billion.

The system was meant to balance innovation and access. Today, it’s tilted too far toward profit. The science behind generics is solid. The FDA is ready. The law just needs to catch up.