Evergreening: How Pharmaceutical Brands Delay Generic Drugs to Protect Profits

When a blockbuster drug’s patent is about to expire, you might expect prices to drop. After all, generics are cheaper, safer, and just as effective. But in many cases, they never show up - not because they can’t be made, but because the original brand has already locked the door. This is evergreening: a legal, calculated strategy used by pharmaceutical companies to stretch patent life by making tiny changes to old drugs. It’s not innovation. It’s a financial maneuver that keeps prices high and patients paying more.

How Evergreening Works - Step by Step

Every new drug starts with a 20-year patent clock. But that clock doesn’t tick down in a straight line. Companies file additional patents - dozens, sometimes hundreds - on minor tweaks: a new capsule shape, a delayed-release formula, a slightly different salt form, or a combo with another drug. Each new patent adds more time. The original patent might expire in 2027, but if a company files five more patents over the next decade, the drug stays protected until 2037 - or even 2040.

Take Humira, the autoimmune drug made by AbbVie. Between 2002 and 2023, AbbVie filed 247 patents on Humira. Over 100 were granted. That’s not innovation. That’s a patent thicket. Each patent covers something so small - like a new injection device or a different dosing schedule - that it wouldn’t qualify as a new drug under normal standards. But under U.S. patent law, it’s enough to block generics.

AstraZeneca did the same with Prilosec and Nexium. Prilosec, a heartburn drug, was a bestseller. When its patent neared expiration, AstraZeneca introduced Nexium - essentially the same active ingredient, just a slightly modified version. They marketed it as "the purple pill," claiming it worked better. In reality, clinical studies showed little to no difference. But Nexium came with a new patent, pushing back generic competition by years. The result? Billions in extra revenue.

The Tools of the Trade

Pharmaceutical companies don’t rely on one trick. They use a playbook:

• Product hopping: Replace the old drug with a new version - often with no real clinical benefit - and stop making the original. Patients are forced to switch, and generics can’t enter until the new patent expires.
• Orphan drug designation: Apply for special status for rare diseases, even if the drug treats common conditions. This gives seven years of exclusivity.
• Pediatric exclusivity: Run small studies on children, even if the drug isn’t meant for them. This adds six months to the patent.
• Authorized generics: Launch a generic version yourself, under your own brand. This keeps control of the market while pretending to allow competition.
• Patent clustering: File dozens of overlapping patents so any generic maker faces a legal minefield. Challenging one patent means risking lawsuits on the other 50.

These aren’t loopholes. They’re features of the system. The 1984 Hatch-Waxman Act was meant to balance innovation and access. But it didn’t account for how aggressively companies would exploit its rules.

Why It Costs Patients

Generic drugs cut prices by 80-85% within the first year. That’s not theory - it’s data. When a drug goes generic, pharmacies and insurers can offer it for pennies on the dollar. But when evergreening blocks generics, those savings vanish.

Humira costs around $7,000 per month in the U.S. without insurance. In Canada, where generics entered earlier, the same drug costs under $100. That’s not because Canada is cheaper - it’s because AbbVie’s patent strategy delayed generic entry for over a decade. Millions of patients with rheumatoid arthritis, Crohn’s disease, and psoriasis paid thousands every month because of it.

AstraZeneca’s strategy on its top six drugs extended patent life by more than 90 years combined. That’s not a typo. It’s 90 years of monopoly pricing on drugs for diabetes, acid reflux, and high blood pressure - conditions that affect tens of millions.

The human cost is real. People skip doses. They ration pills. Some stop treatment entirely. A 2023 study found that 1 in 4 Americans with chronic conditions said they couldn’t afford their meds. Evergreening isn’t the only reason - but it’s a major one.

Is This Legal? Yes. Is It Right?

Legally, most of these tactics are allowed. The U.S. Patent and Trademark Office (USPTO) approves them. Courts often side with the brand. The FDA approves the new formulations. Everything follows the rules.

But the rules were written for real innovation - not for companies that spend $10 million to tweak a pill and then charge $1 billion in extra revenue.

Harvard researchers found that 78% of new patents on prescription drugs were for existing drugs, not new ones. That means most patent activity isn’t about creating new treatments - it’s about extending profits on old ones.

Critics call it a scam. Supporters say it funds future research. But the numbers don’t add up. Developing a new drug costs $2.6 billion and takes 10-15 years. Evergreening costs a fraction of that - often under $100 million - and delivers the same profit. Why invest billions in risky new science when you can tweak a pill and lock in revenue for another decade?

What’s Changing?

Pressure is building. In 2022, the U.S. Federal Trade Commission sued AbbVie over Humira’s patent strategy, calling it an illegal monopoly. The Inflation Reduction Act of 2022 gave Medicare the power to negotiate prices for the most expensive drugs - a direct hit to evergreening’s profit model.

The European Medicines Agency now requires proof of "significant clinical benefit" before granting extra exclusivity. Canada and Australia have stricter rules on product hopping. The World Health Organization has publicly condemned evergreening for blocking access in low-income countries.

Even within the industry, some executives admit the practice is unsustainable. "We’re running out of easy tweaks," one senior patent lawyer told a pharmaceutical conference in 2024. "The next wave will be biologics and nanotech - harder to copy, harder to challenge. But the backlash is coming. We can’t keep doing this forever."

What Can You Do?

As a patient, you have power - even if it feels small.

• Ask your doctor if a generic version is available - even if your prescription says the brand name.
• Check if your drug is on the list of top evergreened drugs. Humira, Nexium, Lipitor, and Singulair are all on it.
• Use mail-order pharmacies or international sources (where legal) to find lower prices.
• Support policy changes. Call your representative. Ask why your tax dollars fund drug patents that block generics.

The system is rigged. But it’s not unbreakable. Every time a court rules against a patent thicket, every time a generic enters the market, prices drop. And every time patients speak up, the pressure grows.

What’s Next?

The next frontier of evergreening isn’t pills anymore. It’s biologics - complex drugs made from living cells. These are harder to copy, and companies are already filing patents on minor variations: new delivery systems, storage methods, or even genetic tests to predict who responds to the drug.

One company is patenting a test that says "only patients with Gene X should use this drug." That test becomes a barrier: if you don’t have Gene X, you’re told the drug won’t work - even though it might. The patent on the test blocks competitors from offering the same test with a cheaper version of the drug.

This isn’t science fiction. It’s happening now. And without tighter rules, it will become the norm.

Final Thought

Evergreening isn’t about saving lives. It’s about saving profits. The drugs themselves aren’t bad - many have saved millions. But the system that lets companies hold them hostage for decades is broken. Patients shouldn’t pay extra because a company spent a million dollars on a new pill shape instead of a billion on a new cure.

The question isn’t whether evergreening works. It does. The question is: who’s paying the price?