Planning for Patent Expiry: What Patients and Healthcare Systems Need to Do Now

Patent expiry isn’t just a legal event-it’s a turning point for your health and your wallet

Every year, dozens of top-selling prescription drugs lose their patent protection. That means cheaper generic versions can hit the market. For patients, that could mean paying 80% less for the same medicine. For hospitals and insurers, it’s a chance to save millions. But here’s the catch: patent expiry doesn’t automatically mean lower prices or smooth transitions. Without planning, patients get switched to unfamiliar pills, pharmacies run out of stock, and savings vanish behind complex rebate deals.

Right now, over $90 billion in brand-name drug sales are at risk of expiring between 2025 and 2029. That’s not a future problem-it’s happening now. Drugs for diabetes, arthritis, high cholesterol, and even cancer are losing patent protection in the next two years. If you or someone you know takes one of these medicines, you need to act before the switch happens.

Why generic drugs don’t always mean instant savings

When a patent expires, generic versions are supposed to be cheaper. And they usually are-often 80-85% lower than the brand-name price within a year. But in the U.S., that savings doesn’t always reach the patient.

Why? Because drug pricing isn’t simple. Brand-name companies often set up rebate deals with pharmacy benefit managers (PBMs). These deals make the brand drug look cheaper to insurers, even when it’s not. When generics arrive, those rebates disappear, but the insurer may not pass the savings on to you. You might still pay the same copay-even though the pharmacy paid far less for the generic.

Plus, not all generics are the same. Some are made by different manufacturers, with different fillers or coatings. For most people, that doesn’t matter. But for patients on tight-dose medications-like blood thinners or epilepsy drugs-even small differences in how the drug is absorbed can cause side effects. A 2022 Kaiser Family Foundation survey found 37% of patients reported new symptoms after switching to a generic, even though the FDA says they’re bioequivalent.

What healthcare systems are doing (and what they should be doing)

Hospitals and health systems that plan ahead save big. A 2023 analysis of 150 health systems showed those who started planning 24 months before patent expiry saved 22% more than those who waited until 12 months out. That’s an extra $900,000 per drug on average.

Successful systems do four things early:

1. Track expirations-They use software like Symphony Health’s PatentSight to monitor over 1,400 patent expiration dates each year in the U.S. alone.
2. Build a team-Pharmacists, doctors, finance staff, and contract managers meet regularly to review which drugs are expiring and what generics are coming.
3. Update formularies-They decide which generic to prefer *before* the patent expires, so prescriptions switch smoothly.
4. Prepare patients-They send out clear letters and hold Q&A sessions so patients know what to expect, why the change is happening, and how to report side effects.

Smaller clinics struggle with this. A 2022 survey found 58% of medical groups didn’t have enough staff or tools to track multiple expirations at once. If you’re a patient at a small practice, don’t wait for them to act-ask your doctor or pharmacist about your meds.

Biologics and biosimilars: The next big wave

Not all drugs are created equal. Small-molecule pills (like atorvastatin or metformin) are easy to copy. But biologics-injectable drugs made from living cells, like Humira or Enbrel-are far more complex. Their copies aren’t called generics; they’re called biosimilars.

Biosimilars take longer to develop, cost more to make, and face more regulatory hurdles. As a result, they don’t drop in price as fast. While small-molecule generics hit 90% market share within a year, biosimilars only reach 38% after two years. And in autoimmune diseases like rheumatoid arthritis, adoption is even slower-just 18% in some cases.

Why? Doctors are cautious. Patients are worried. And insurers haven’t pushed hard enough to switch. But that’s changing. By 2028, IQVIA predicts biosimilars will capture 45% of the biologics market, saving $150 billion cumulatively. If you’re on a biologic, ask now: Will my drug lose patent protection soon? What biosimilars are approved?

How to protect yourself as a patient

You don’t need to be an expert to prepare. Here’s what you can do today:

• Check your meds-Look up your prescription on Drugs.com or the FDA’s Orange Book. Search for the brand name and see if there’s an “expiration date” listed for patent protection. If it’s within the next 18 months, get ready.
• Ask your pharmacist-When you refill your prescription, ask: “Is there a generic coming? Will I be switched? What’s the difference?”
• Don’t assume your copay drops-Just because the drug is cheaper doesn’t mean your out-of-pocket cost will fall. Call your insurer and ask: “If my drug switches to a generic, will my copay change?”
• Report side effects-If you feel different after switching to a generic-more fatigue, dizziness, or nausea-tell your doctor. It’s not “all in your head.” Differences in inactive ingredients can affect how your body handles the drug.
• Know your rights-Under Medicare Part D, you can request a formulary exception if your new generic isn’t working. You don’t have to accept a switch if it harms your health.

The hidden traps: Patent thickets and pay-for-delay

Big drug companies don’t just wait for patents to expire. They fight to delay them. One common trick? Filing dozens of secondary patents on tiny changes-like a new coating, a different pill shape, or a slightly slower-release version. This is called a “patent thicket.” Nearly 80% of the top 100 selling drugs have over a dozen patents each.

Another tactic? “Pay-for-delay.” That’s when the brand-name company pays a generic maker to stay off the market. The FTC says these deals cost U.S. consumers $13 billion a year. While new laws like the 2023 CREATES Act are cracking down, they’re still happening.

What does this mean for you? Even if a patent is supposed to expire in June, the generic might not show up until October-or never. That’s why planning can’t just be about the calendar date. You need to know if the drug is likely to face delays.

What’s changing in 2025 and beyond

The rules are shifting. The Inflation Reduction Act of 2022 lets Medicare negotiate prices for drugs after patent expiry-starting in 2026. That could affect 10-20 drugs per year, forcing companies to lower prices faster.

The FDA is also speeding things up. Its new GDUFA III rules aim to cut approval times for complex generics from 18 to 12 months. And Congress is debating the Pharmaceutical Patent Reform Act, which could shorten the 180-day exclusivity window for the first generic maker-making it harder for one company to monopolize the market after expiry.

Meanwhile, AI tools are helping health systems predict expirations more accurately. Systems using AI now forecast patent dates with 89% accuracy-up from 65% just two years ago.

Bottom line: Don’t wait for the switch

Patent expiry is inevitable. But the impact isn’t. If you’re on a chronic medication, especially one costing over $100 a month, you’re in the crosshairs of this wave. The difference between planning ahead and doing nothing could be hundreds or even thousands of dollars a year.

Start now. Find out what drugs you take are nearing expiry. Talk to your pharmacist. Ask your doctor about alternatives. Don’t let confusion, inertia, or corporate maneuvering cost you your health-or your money.

Next steps: What to do right now

Don’t wait for your doctor to bring it up. Take control:

1. Make a list of all your prescriptions, especially if you take them daily.
2. Look up each one on the FDA’s Orange Book or ask your pharmacist: “Is this drug losing patent protection soon?”
3. If it’s within 12-18 months, schedule a conversation with your doctor: “What happens when the generic comes? Are there alternatives?”
4. Call your insurance company and ask: “If this drug becomes generic, will my copay change? Will I be switched automatically?”
5. Set a reminder for 6 months before the expected expiry date to check in again.

Patent expiry is one of the biggest cost-saving opportunities in healthcare today. But only those who plan ahead actually benefit. You have the power to make sure you’re one of them.