By the PharmaTradz BD Team. Published November 2026.
Most attention goes to the US drug shortage list. The FDA's list of medicines being discontinued gets far less, yet for manufacturers and exporters it is often the more useful of the two. A shortage may resolve in weeks. A discontinuation is a company's permanent decision to stop making a product, and it can leave a gap in the market that lasts for years.
At the start of November 2026 our drug shortage radar, which follows the FDA's data, showed roughly 160 medicines with a presentation listed as being discontinued, against about 70 in active shortage. This guide explains what a discontinuation listing actually means, how to judge whether it is an opportunity, and the routes for supplying the US market. It is not regulatory advice.
What a discontinuation listing means
US law requires the holder of an approved application for many prescription drugs to notify the FDA when it plans to stop making a product permanently, normally at least six months in advance, or as soon as possible when that is not practicable. The FDA then shows the affected presentations as "to be discontinued" in its shortage database.
Three points are easy to miss:
- It is usually one company's product, not the whole medicine. A listing for metformin extended-release tablets, for example, typically refers to one manufacturer's presentations. Other approved versions may still be on the market.
- Reasons are rarely given. Most discontinuations are business decisions: low prices, small volumes or a site being closed. They are seldom about safety.
- The approval may not disappear. The company may keep its application inactive, sell it, or ask the FDA to withdraw it. A dormant approval can sometimes be bought and relaunched.
Is it an opportunity? Four questions
- Who else supplies it? Check how many other approved versions are actually marketed. If the discontinuing company was one of only one or two suppliers, the gap is real. If ten others remain, there is little to fill.
- Is demand stable? Hospital injectables and older medicines with no close substitute, such as some anticonvulsants, hormone injections and anticoagulants, tend to keep steady demand. Products being replaced by newer therapies may not.
- Is there a price signal? Discontinuations often follow years of price erosion. Check whether prices have started to recover; if they have not, the economics that pushed the last supplier out may push you out too.
- How fast can you get there? Your options range from months to years, as the table below shows.
Routes to supply the US market
| Route | Who it suits | Typical time |
|---|---|---|
| Increase supply under an existing approval | Companies already holding an approval (ANDA or NDA) for the product | Weeks to months |
| Acquire or license a dormant approval | Companies with US-ready manufacturing and a site that can be added | Months, plus any site-change supplement |
| File a new generic application (ANDA) | Companies with a developed product and bioequivalence data | Usually two years or more from filing to approval |
| Temporary importation during a critical shortage | Companies with the product approved in another well-regulated market, at the FDA's request | Only while a shortage lasts |
| Outsourcing facility (503B) compounding | US outsourcing facilities, for drugs on the FDA shortage list | Short-term, shortage-linked |
The FDA also prioritises review of some generic applications for medicines in shortage or with few competitors, which can shorten the path for a well-prepared filing.
Beyond the United States
A US discontinuation is often a signal for other markets too. When a large manufacturer exits a product, it frequently withdraws it from several countries at once, and hospitals in markets that imported the product may suddenly need a new source. Health Canada, the UK's MHRA and Australia's TGA all publish their own shortage and discontinuation lists, and some allow temporary import of foreign-approved versions during critical shortages.
How PharmaTradz can help
Our drug shortage radar lists every US shortage and discontinuation, grouped by medicine and refreshed daily from the FDA's data, with the affected presentations and therapy areas. You can filter by status, dosage form and therapy area, and sign up for alerts when new items appear.
If you hold an approval for a medicine on the list, or have capacity for one, tell us what you can supply. We pass qualified offers to hospitals, wholesalers and tender buyers. If you are a buyer looking for a replacement source, send us the product and quantity and we will come back with licensed options and their documents.
Frequently Asked Questions(FAQs)
What does "to be discontinued" mean on the FDA shortage list?
The holder of an approved application has told the FDA it will permanently stop making certain presentations of a medicine. It usually concerns one company's product, not every version of the medicine.
How much notice must a company give?
For many prescription drugs, US law requires notice at least six months before a permanent discontinuation, or as soon as practicable if six months is not possible.
Is a discontinuation the same as a shortage?
No. A shortage is a temporary gap between supply and demand. A discontinuation is a permanent exit by one supplier, which may or may not lead to a shortage depending on how many other suppliers remain.
How can a manufacturer supply a discontinued medicine in the US?
By increasing supply under an existing approval, acquiring a dormant approval, filing a new generic application, or, during a critical shortage, through temporary importation at the FDA's request.
Where can I see current US shortages and discontinuations?
The PharmaTradz drug shortage radar lists them by medicine, refreshed daily from the FDA's data, with filters by status, dosage form and therapy area.
