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ATC L04AK01 · Dihydroorotate Dehydrogenase (DHODH) Inhibitors · updated 4 Nov 2026

Leflunomide shortage

As of 4 Nov 2026, Leflunomide has a reported shortage in 3 of the 16 countries we track (United States, Canada, Italy), covering 5 products from 3 companies.

Is there a Leflunomide shortage?

Yes. As of 4 Nov 2026, Leflunomide is reported short in 3 of the 16 countries we track: United States, Canada, Italy. The earliest expected return is 11 Dec 2026 (Canada). 4 of 5 affected products have no return date.

Countries3/16
Products5packs or presentations
Companies32 listed
Short since27 Oct 20233.0 years ago
Earliest return11 Dec 2026company estimate
Main reasonNot stated
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United States3 products shortCanada1 product shortGermanyNo reported shortageFranceNo reported shortageItaly1 product shortSpainNo reported shortageIrelandNo reported shortageAustriaNo reported shortageBelgiumNo reported shortageSwitzerlandNo reported shortageCzechiaNo reported shortageNorwayNo reported shortageSwedenNo reported shortageJapanNo reported shortageNew ZealandNo reported shortageAustraliaNo reported shortage

How the shortage spread

All cross-border shortages

Countries in the order the shortage started there (earliest start date of a product still short). First reported in Italy on 27 Oct 2023; most recently in Canada on 13 Jul 2026.

Not on the official list in: Germany, France, Spain, Ireland, Austria, Belgium, Switzerland, Czechia, Norway, Sweden, Japan, New Zealand, Australia.

Timeline

United StatesCanadaItaly
202420252026Arava, Tablet, 10 mg (NDC 0088-2160-30)Arava, Tablet, 10 mg (NDC 0088-2160-30)Arava, Tablet, 100 mg (NDC 0088-2162-33)Arava, Tablet, 100 mg (NDC 0088-2162-33)Arava, Tablet, 20 mg (NDC 0088-2161-30)Arava, Tablet, 20 mg (NDC 0088-2161-30)SANDOZ LEFLUNOMIDE (30FCT)SANDOZ LEFLUNOMIDE (30FCT)LEFLUNOMIDE ZENTIVALEFLUNOMIDE ZENTIVAtoday

Solid bars run from the reported start to today; faded bars show the time left until the expected return. An arrow means no return date was given.

Which companies are short

products short, all countries
Sanofi3 SANSandoz1 SDZZentiva1

Listed: Sanofi SAN · Euronext Paris, Sandoz SDZ · SIX Swiss

Compared with similar medicines

ATC group L04AK · Dihydroorotate Dehydrogenase (DHODH) Inhibitors
Teriflunomide4/16Leflunomide3/16

Affected products

CountryProductCompanySinceExpected backReason
USArava, Tablet, 10 mg (NDC 0088-2160-30) discontinuationSanofi-Aventis U.S. LLC8 Jun 2026not givenNot stated
USArava, Tablet, 100 mg (NDC 0088-2162-33) discontinuationSanofi-Aventis U.S. LLC8 Jun 2026not givenNot stated
USArava, Tablet, 20 mg (NDC 0088-2161-30) discontinuationSanofi-Aventis U.S. LLC8 Jun 2026not givenNot stated
CASANDOZ LEFLUNOMIDE (30FCT)SANDOZ CANADA INCORPORATED13 Jul 202611 Dec 2026Increased demand
Demand increase for the drug
ITLEFLUNOMIDE ZENTIVAZENTIVA K.S.27 Oct 2023not givenManufacturing problem
Problemi produttivi

"Expected back" is the date the company gave the authority, when it gave one. Ask a pharmacist about alternatives.

Questions

Is there a Leflunomide shortage?

Yes. As of 4 Nov 2026, Leflunomide is reported short in 3 of the 16 countries we track: United States, Canada, Italy. The earliest expected return is 11 Dec 2026 (Canada). 4 of 5 affected products have no return date.

When will Leflunomide be back in stock?

Companies expect supply back from 11 Dec 2026 in Canada; United States: no date given; Canada: 11 Dec 2026; Italy: no date given. These are company estimates reported to each authority.

Why is Leflunomide in short supply?

The most common reason reported is: not stated. Reasons by product are listed in the table below.

Which companies have Leflunomide shortages?

Sanofi, Sandoz, Zentiva.