Relearning Lessons from the High Price of Epinephrine

By ALDP Co-founders Michael Glassner and Jason Young

Aug. 25, 2026 – Every August, a familiar arithmetic problem lands on kitchen tables across the country. It has no good answer, and that is not an accident.

A child with a severe allergy needs epinephrine within reach when anaphylaxis strikes – not in mom’s purse at work, not in a cabinet at home while the child is at school. For many families that means one supply at home and another at school, and families are commonly advised to keep two doses on hand, because some reactions require a second.

For years, Mylan (now part of the global pharmaceutical manufacturer Viatris) made that arithmetic harder. EpiPen was sold in the United States only as a two-pack, so a parent could not simply buy the number of injectors a child actually needed. Then the devices expired, and families started over.

Now multiply by the number of children in the house.

Not the typical story about an expensive new drug

Epinephrine is not new. It has been used in medicine for more than a century, and the medicine inside an auto-injector is inexpensive.

The monopoly power was not in the medicine. It was in the delivery mechanism – in the auto-injector market built around the drug.

Patents surrounding injector devices, and the difficulty of developing a substitutable generic drug-device combination, created a formidable moat. Some of that difficulty may have been legitimate: an emergency device has to work reliably, and a frightened caregiver has to be able to use it correctly. But the result was extraordinary market power.

By 2016, EpiPen overwhelmingly dominated the U.S. auto-injector market, and the bipartisan leaders of the House Oversight Committee wrote to Mylan’s CEO that the company held a “virtual monopoly.” The price trajectory was steep: about $100 for a two-pack in 2007, about $600 by 2016. Competitors were delayed, rejected or recalled. The first FDA-approved generic substitute for EpiPen did not arrive until August 2018.

And the delay was not only a story about hard patents and slow regulation.

In 2017, Mylan paid $465 million to resolve federal and state claims that it had misclassified EpiPen under the Medicaid drug rebate program and underpaid rebates owed to taxpayers. The settlement carried no finding of wrongdoing.

This spring, North Carolina reached a separate $11 million settlement over allegations that included paying for formulary placements that shut out lower-cost competitors, delaying generic competition, misclassifying EpiPen under the Medicaid drug rebate program, and forcing consumers into two-packs they did not always need.

Parents were not imagining that they had very few ways out.

Why we start upstream

There is a version of the drug pricing debate that stops at the pharmacy counter: cap what the patient pays and call it solved.

We support cost-sharing caps. Several states have enacted them for epinephrine, and they bring real relief to families.

But caps protect the family at the counter. They do not make the pharmaceutical industry more accountable. They do not discipline pharma’s pricing practices. The underlying cost does not disappear – it is shifted elsewhere in the system. Protecting patients from an unaffordable bill matters, but it is not the same thing as making the market work.

So what does?

Clear a path for competitors. Scrutiny of patent thickets, limits on anticompetitive agreements, and an efficient regulatory pathway for generics and biosimilars all shorten the distance between an old medicine and real competition. Teva’s generic arrived in 2018, years after families needed it.

Make private entry viable. Sometimes a would-be competitor weighs development cost, litigation risk and uncertain market access, and simply decides not to enter. States can change that calculation without becoming drug manufacturers themselves. Oklahoma’s SB 1344 created a fund meant to do exactly that for biosimilar insulin. Civica shows what a partner on the other side of such an arrangement looks like: the nonprofit manufacturer worked with California to bring a lower-cost insulin to market and sells it nationally at a single transparent price. Government does not have to make a medicine to help create competition. Purchasing commitments and a state’s leverage as a major buyer can do it.

Make sure the cheaper product reaches the patient. Manufacturing an alternative is only half the job. Pharmacies have to stock it and plans have to cover it. Insurers and pharmacy benefit managers perform functions that plans and employers genuinely value, but rebate-driven formulary economics can favor a higher-list-price product carrying a large rebate over a lower-price competitor.

Louisiana’s HB 870, enacted this year, takes direct aim at that problem. It generally requires qualifying lower-cost generics and biosimilars to receive more favorable formulary treatment than the brands they compete with, and bars prior authorization or step therapy that makes the cheaper option harder to reach – while allowing plans to show when net costs tell a different story.

States should modernize the practical rules, too. School statutes written around a particular device design age badly as new FDA-approved forms of epinephrine reach the market. Laws should focus on safe access, not freeze yesterday’s technology into statute.

The lesson we keep coming back to

A decade ago, parents came to the Food and Drug Administration and told the Commissioner what this market looked like from their side of the pharmacy counter.

One of us was in those rooms.

They spoke urgently, and sometimes angrily, about prices, shortages, and the difficulty of keeping enough epinephrine where their children needed it. Their question was straightforward: what could FDA do?

FDA could not change the price. That was not – and is not – in its authority.

But it could work on competition. In August 2018, FDA approved the first generic EpiPen. That same back-to-school season, amid a national shortage, the agency reviewed stability data and extended the expiration dates on certain EpiPen lots by four months.

Neither action fixed the market. Both mattered.

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Eight years on, the market does look different. Several manufacturers sell epinephrine auto-injectors today, and a family who knows exactly what to ask for can find a two-pack for a fraction of what EpiPen once cost.

But brand EpiPen still costs hundreds of dollars, years after a substitutable generic arrived. The same medicine carries dramatically different prices depending on which device gets filled, which pharmacy fills it, and which plan is paying. The lowest price often goes to the family that did the homework, rather than the family that simply walked into the pharmacy.

And the newest entrant illustrates how much work remains. Neffy, the first needle-free epinephrine nasal spray, is a genuine innovation. But it came to market with a list price alongside the expensive brands, not the lower-cost generics – even as its manufacturer created separate programs that can substantially lower what eligible patients actually pay.

Approving competitors was necessary. It was not sufficient. A competitive market should not require parents to become experts in manufacturer programs, device alternatives, formularies, and pharmacy pricing just to find an affordable supply of a century-old medicine.

That is why our work starts upstream – with the price, the competition, and the incentives that shape the market – and follows them all the way to the pharmacy counter.

The families in those FDA rooms did not need another explanation of why the system was complicated. They needed a market that worked.

Eight years later, that remains the assignment.