How Long Do FDA Drug Shortages Last? The Average Is Now 5.3 Years

Ask most people how long a drug shortage lasts and they will guess weeks, maybe a couple of months. The real number, from the U.S. Pharmacopeia's 2025 annual drug shortages report, is an average of 5.3 years. That is not a hiccup in the supply chain. That is a chronic condition.

The report, based on the FDA's drug shortage database through the end of 2025, tells a story with two faces: fewer shortages than the peak, but the ones that remain are the stubborn ones. Here are the numbers that matter.

How long drug shortages last: the numbers

At the end of 2025, the FDA listed 75 drugs in shortage. That is down from 98 a year earlier and well down from the high of 125 at the end of 2023: the second consecutive yearly decline. Good news, on its face.

Now the other face. Only 4 of those 75 shortages began in 2025. The other 71 carried over from earlier years. Nearly two-thirds, 64%, have been in shortage for more than 3 years, and 39% have lasted longer than 5 years. The median shortage duration climbed to 5 years, up from 4.3 in 2024 and just 2 in 2019. The average now sits at 5.3 years: the longest average duration ever recorded, and more than double the roughly 2-year average reported in 2019.

So yes, the count is falling. But the shortages that resolve tend to be the easy ones. What is left is a core of long-running shortages that keep getting longer.

What is actually in shortage

Sterile injectable drugs, which are complex to manufacture, account for 71% of active shortages. Oral solid drugs account for 16%. The hardest-hit therapeutic categories are pediatrics with 16 shortages, gastroenterology with 11, anesthesia with 10, endocrinology and metabolism with 10, and oncology with 6.

There is a related number worth knowing: drug discontinuations jumped 60% year over year, the largest single-year increase since 2019. Two-thirds of discontinued oral solid products were priced below $1 per unit. When a drug costs less than a dollar, the economics of keeping it in production get brutal, and some manufacturers simply walk away.

Why shortages last years instead of weeks

USP names the same 4 interconnected drivers every year: low prices, manufacturing complexity, geographic concentration, and quality concerns. The logic is grim but simple. Thin margins mean few manufacturers bother making a drug, which means no spare capacity when one of them has a quality problem or shuts a plant. Complex sterile manufacturing cannot be spun up overnight, and concentrated supply chains mean a single disruption echoes everywhere. When the economics do not support a second factory, nobody builds one, and the shortage persists for years.

What this means if your prescription is affected

The practical takeaway: do not wait it out. A shortage with a 5-year median duration is not resolving before your next refill. Talk to your prescriber and pharmacist about therapeutic alternatives now, not after the third "still on backorder" phone call. Check the current shortage list so you know whether your medication is listed, and ask about extended use dates and partial fills. Our backorder playbook walks through the exact steps.

My opinion, stated plainly: "shortages decline" is a true headline and a misleading one. The count is the number regulators watch. Duration is the number patients live with, and it is going the wrong way.

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Related: What to Do When Your Prescription Is on Backorder Partial fills, other pharmacies, prescriber alternatives, and insurer coverage. Why Are Generic Drugs in Shortage in 2026? The economics behind the empty shelf: thin margins, sole-source products, and a supply chain with no spare capacity.