Air Apparent: Patent Law Is Choking Inhaler Affordability

By Joy Victory
July 8, 2025 | VOLUME 3, ISSUE 2

As a pulmonary fellow in 2017, William Feldman, MD, MPH, found himself staring at a poster of available inhalers for asthma and COPD. These types of posters are a common sight in medical offices, but Dr. Feldman couldn’t help but notice an upsetting pattern.

“Not a single inhaler on the poster was generic, despite many of the active ingredients being around for 30 years or more,” said Dr. Feldman, a pulmonologist, intensivist, and health services researcher at Harvard Medical School and Brigham and Women's Hospital.

At the time, he had several patients struggling to pay for their inhalers, even though they were often reluctant to admit it. As a result, his patients were struggling to stay healthy.

“A patient who can’t pay for the medication will not take the medication,” he said. “It’s that simple.”

It’s also a common problem. Close to 40 million Americans use daily or rescue inhalers for either asthma or COPD. While coupons and generous insurance plans help lower out-of-pocket costs for some, these products remain substantially more expensive in the United States compared with prices in other countries. As a result, patients are less likely to take lifesaving medications.

A prime example is one particular inhaler—containing albuterol (first approved in 1981) and ipratropium (first approved in 1986)—that still faces no generic competition. In the United States, it costs about $600 for a month’s supply before rebates or other discounts. In Canada, it retails for about $90.

Normally, drug patents last for about 20 years, but drug companies have found many ways to work the system so that generics stay off the market. This raises health care costs in the form of higher insurance premiums and taxes that fund federal health programs like Medicare and Medicaid, Dr. Feldman said.

The lack of generic options motivated him to research the problem as part of his role with Brigham and Women's Hospital and Harvard Medical School’s Program On Regulation, Therapeutics, And Law (PORTAL), which examines US drug policy and affordability. He and colleagues discovered that pharmaceutical firms take advantage of the US patent system to limit generic competition and extend market exclusivity on their products, which keep drug costs high.

Their research has drawn the attention of major news outlets, as well as lawmakers looking for clear ways to lower drug costs. Last year, Dr. Feldman testified at a US Senate Judiciary Committee meeting about the problem.

During his testimony, he focused on drug-device combinations, including inhalers and insulin injectors, which are particularly susceptible to patent manipulations. Firms will seek out numerous patents around both the active formulation and the devices themselves, establishing so-called “patent thickets.”

They also engage in “product hops,” making minor modifications to the drug or the device and then releasing new versions with fresh patent protections. These new products often offer no clinical benefit over existing products, Dr. Feldman explained.

At the Senate hearing, Dr. Feldman suggested additional solutions that would piggyback on four pending bills already under consideration. They include granting the US Food and Drug Administration more authority to evaluate patents for drugs and drug-devices and giving the organization more resources to approve generic drug-device combinations that differ slightly from brand-name reference products (while still containing the same active ingredients).

Some positive developments have occurred in recent years. Notably, there are now generic inhalers for five brand-name products since they first reached the market in 2019—though that’s far from enough for optimal health care delivery, Dr. Feldman noted. Additionally, some companies have been pulling improperly listed device-only patents in response to action by the Federal Trade Commission, which remains ongoing.

After years of advocacy work from experts like Dr. Feldman, several drug companies have also announced $35 price caps on their inhalers—though clinicians would still do well to direct their patients to download coupons from company websites to ensure the discount is applied at the pharmacy, he said. In theory, these discounts should be applied automatically at the counter, Dr. Feldman said, but this doesn't always happen the way it should. It is also important to note that more than half of the inhalers dispensed in the United States every year are to patients covered by Medicare or Medicaid, and the $35 cap on out-of-pocket expenses does not apply to them.