30-Month Stay: How Litigation Delays Generic Drug Approval

The 30-month stay is one of the most powerful tools in U.S. drug policy - not because it speeds up access to cheap medicines, but because it can hold them back for years. It’s not a law you hear about on TV, but it’s the reason millions of Americans pay hundreds of dollars more for prescriptions than they should. This isn’t about bad actors or corporate greed alone - it’s a system designed to balance innovation and access, but in practice, it often tips hard in favor of brand-name drug makers.

How the 30-Month Stay Actually Works

When a generic drug company wants to sell a copy of a brand-name medicine, they file something called an Abbreviated New Drug Application, or ANDA. But if that brand-name drug is still under patent, the generic maker has to challenge it. They do this by filing what’s called a Paragraph IV certification. It’s basically a legal notice saying: "We think your patent is invalid, or we won’t infringe it."

Once that notice is sent, the brand-name company has 45 days to sue. If they do, the FDA is forced to pause final approval of the generic drug for up to 30 months. That’s the 30-month stay. It doesn’t stop the FDA from reviewing the application. In fact, they can - and often do - give what’s called tentative approval during this time. But they can’t let the drug hit the market until the clock runs out or the court decides the patent is invalid.

Here’s the kicker: the 30-month clock doesn’t start when the lawsuit is filed. It starts when the last patent holder gets the notice. And if the lawsuit drags on past 30 months? The stay can extend. Courts can shorten it, but they rarely do. That means a generic drug can sit in limbo for years - even if the patent should’ve expired long ago.

Why This Matters: The Real Cost of Delay

In 2022, the FDA received over 1,000 ANDAs. Nearly 80% of them were under patent litigation. That’s not a coincidence. It’s the norm. And while the FDA can tentatively approve these drugs, final approval doesn’t mean immediate market entry. The median time between a 30-month stay ending and a generic drug actually launching? 3.2 years.

Why so long? Because the delay isn’t just legal. It’s commercial. Generic companies spend millions on litigation. They delay manufacturing ramp-up. They wait to see if a competitor will win first-to-file exclusivity. They fear being sued again on another patent. And brand-name companies? They use this time to tweak the drug - change the dosage, switch the pill shape, add a new coating - and file new patents. These aren’t breakthroughs. They’re tricks. A 2019 Brookings study found that 67% of patents listed for top-selling drugs were filed after the original approval. That’s patent evergreening. And it’s legal.

The result? A 2021 FTC report showed that 78% of Paragraph IV lawsuits ended in settlements that delayed generic entry beyond patent expiration. These aren’t court victories. They’re backroom deals. The generic company agrees to wait months or even years before launching - in exchange for a cut of the brand’s profits. This is called "pay-for-delay." And it’s costing U.S. consumers $13.9 billion a year in extra drug costs.

Who Wins? Who Loses?

Brand-name drug companies say the 30-month stay is necessary to protect innovation. Without it, they argue, no company would invest $2.6 billion to develop a new drug. And there’s truth to that. The system has helped bring over 14,000 generic drugs to market since 1984. But the numbers don’t lie: the average brand-name drug faces its first generic challenge 5.2 years after FDA approval. That’s not a rush to market. That’s a long runway for profits.

Meanwhile, generic manufacturers spend $3 to $5 million per ANDA just on patent litigation. A 2022 survey found 78% of them said the threat of litigation adds 6 to 9 months to their development timelines. That’s not just money. It’s time. Time they could’ve spent making more drugs.

And patients? They’re stuck paying full price. A 2022 Congressional Budget Office report found that generic competition typically drops drug prices by 80-85% within a year. But if the generic can’t launch because of a 30-month stay, that price drop doesn’t happen. For drugs like Humira, which had over 20 patents listed in the Orange Book, patients waited over a decade for affordable alternatives.

How It Compares to the Rest of the World

The U.S. is the only country that ties regulatory approval directly to patent litigation. In Europe, generic companies can file for approval as soon as the data exclusivity period ends - no lawsuits needed. Canada has a 24-month stay, but it’s simpler. No multiple patents. No endless litigation.

The U.S. system is uniquely complex. And it’s getting worse. In 1995, brand-name companies listed an average of 1.2 patents per drug in the FDA’s Orange Book. By 2022, that number had jumped to 8.3 patents. That’s not innovation. That’s a wall. And the 30-month stay is the gatekeeper.

What’s Changing? And What Could Change Next

Pressure is building. In 2023, Congress introduced the Affordable Prescriptions for Patients Act, which would cut the 30-month stay down to 18 months and ban stays for secondary patents. The FTC has called for reform, saying the system "creates unnecessary barriers." Even former FDA Commissioner Scott Gottlieb, once a defender, now admits the system is "stretched too thin."

The FDA itself is pushing for more transparency. Their 2023 draft guidance asks companies to list only patents that truly cover the drug’s active ingredient - not every minor variation. That could block a lot of frivolous lawsuits.

But the biggest shift might come from outside. Chinese and Indian manufacturers now make up 63% of all ANDA submissions. They’re not afraid of U.S. patent law. They’re building factories, hiring lawyers, and filing challenges faster than ever. And they don’t play by the same rules. If the 30-month stay is meant to protect U.S. innovation, it’s failing - because the next wave of generics won’t come from Pfizer or Merck. They’ll come from Sun Pharma and Cipla.

The Bottom Line

The 30-month stay was never meant to be a delay tactic. It was meant to be a pause - a chance for courts to decide patent disputes without chaos. But today, it’s a weapon. A tool for extending monopolies. A barrier for patients who can’t afford their meds. And a financial burden for companies trying to do the right thing.

There’s no magic fix. But if the stay were shortened, or if secondary patents couldn’t trigger it, generic drugs could reach patients months - even years - sooner. That’s not just policy. That’s money in people’s pockets. That’s health.