Leflunomide Tablet shortage
Leflunomide Tablet is currently listed in shortage by the FDA. The FDA lists 5 affected products. This page was last refreshed from FDA data on Sep 25, 2026.
Sanofi-Aventis is permanently stopping its manufacture of leflunomide tablets. Other makers — including KVK-Tech, Heritage Pharmaceuticals, Burel Pharmaceuticals, and AvKARE — still list leflunomide 10 mg and 20 mg tablets as available.
Don’t stop or change your therapy on your own — talk with your prescriber about the plan that fits you, and ask your pharmacist what’s actually available (see options).
Do you take this drug? See the ‘What to do’ recommendation from Dr. Brian Staiger, PharmD →What’s in shortage — at a glance
These figures count only the manufacturers that reported this shortage to the FDA — not every company that makes Leflunomide Tablet. Other makers that haven’t reported a problem are shown in the green card below.
Shortage timeline
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Jun 8, 2026Currently in shortage5 of 5 products affected.
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Jun 8, 2026First reported to the FDA5 products first listed.
Built from FDA posting and update dates. The end date FDA publishes is the posting/update date, not a true resolution date, so durations are approximate.
What exactly is on backorder — by manufacturer
Manufacturer: Sanofi-Aventis U.S. LLC 📞 800-981-2491 5 NDCS click to expand
| Status | NDC / product | Strength | Availability | Related information | Reason |
|---|---|---|---|---|---|
| To Be Discontinued | Leflunomide, Tablet, 10 mg (NDC 0955-1735-30) | — | — | Discontinuation of the manufacture of the drug | — |
| To Be Discontinued | Leflunomide, Tablet, 20 mg (NDC 0955-1737-30) | — | — | Discontinuation of the manufacture of the drug | — |
| To Be Discontinued | Arava, Tablet, 100 mg (NDC 0088-2162-33) | — | — | Discontinuation of the manufacture of the drug | — |
| To Be Discontinued | Arava, Tablet, 10 mg (NDC 0088-2160-30) | — | — | Discontinuation of the manufacture of the drug | — |
| To Be Discontinued | Arava, Tablet, 20 mg (NDC 0088-2161-30) | — | — | Discontinuation of the manufacture of the drug | — |
These rows are manufacturer reports to the FDA for Leflunomide Tablet — they do not necessarily cover every manufacturer that makes this drug. A company appears here only if it told the FDA it has a supply problem, so other makers may still have stock. That’s the basis for the Where else can I get Leflunomide Tablet? options further down this page.
Why is Leflunomide Tablet in shortage?
Sanofi-Aventis has reported to the FDA that they are permanently stopping the manufacturing of all of their leflunomide tablets — this includes both the brand-name Arava and their generic leflunomide, in all three strengths: 10 mg, 20 mg, and 100 mg. This is a full discontinuation, meaning these specific products from this manufacturer will not be coming back.
It's worth knowing that this report only covers Sanofi-Aventis and their products. The FDA did not provide a specific reason for why they made this decision — just that manufacturing is being permanently discontinued. Other manufacturers of leflunomide are listed separately on the FDA shortage page and are not part of this report.
Based on the manufacturer-reported reason(s) and notes on file with the FDA for Leflunomide Tablet, summarized in plain English by HelloPharmacist. A drug can be short for more than one reason, and the FDA updates these as manufacturers report changes.
What should I do if I take Leflunomide Tablet?
Leflunomide tablets are currently on the FDA drug-shortage list. I want to walk you through what this means so you can plan your next step calmly.
This shortage record covers all three strengths — the 10 mg, 20 mg, and 100 mg tablets — and none of them has an available source from the manufacturer that filed this report. The reason listed for each strength is that this maker is discontinuing production of the drug. Because this is a discontinuation rather than a temporary delay, the supply problem from this manufacturer may be permanent, which makes a conversation with your prescriber the right next step.
It is important to know that this report reflects only one manufacturer. Leflunomide in the same tablet form is still listed from several other makers, so your medicine may still be available elsewhere.
Here is what I suggest:
- Do not stop, skip, or change your dose on your own.
- Ask your pharmacy to check wholesalers and other manufacturers — the same medicine (leflunomide 10 mg and 20 mg tablets) is still made by companies such as KVK-Tech, Avet, Burel, AvKARE, AvPAK, and Aurobindo, though it may not be in local stock.
- If your exact strength cannot be found, ask your prescriber or pharmacist about suitable options.
- Manufacturer contact numbers are listed on this page for reference; pharmacies usually handle these calls.
This is general, national information and may not match your pharmacy's actual stock.
- Don’t stop or change the medication on your own — talk to your prescriber first.
- If this is part of an ongoing or essential regimen (for example HIV treatment or prevention, seizure, heart, transplant, diabetes or mental-health medicines), do not skip or ration doses — contact your pharmacist or prescriber right away to arrange continued supply before you run out.
- Ask your pharmacy to check other manufacturers, strengths, package sizes, and nearby stores.
- Ask your prescriber whether a different strength, formulation, or the brand/generic version is appropriate.
Where else can I get Leflunomide Tablet?
FDA shortages are manufacturer-reported — a company only shows up on the shortage list if it told the FDA it has a supply problem, so not every maker of Leflunomide Tablet is necessarily short. Below we pull together the other still-marketed options that are not reported in shortage: the same medicine from manufacturers that haven’t reported a problem, and alternative dosage forms. These may still be out of stock at your pharmacy, and only your prescriber or pharmacist can decide what’s right for you.
Same medicine, other manufacturers (not reported short)
Same active ingredient, dosage form & route as the shortage (matched on the FDB HICL ingredient code), from makers that have not filed a shortage with the FDA:
| Product | Strength | Form / route | Manufacturer | NDC |
|---|---|---|---|---|
| Leflunomide | LEFLUNOMIDE 10 mg/1 | Tablet · Oral | KVK-Tech, Inc. | 10702-0277-03 |
| Leflunomide | LEFLUNOMIDE 20 mg/1 | Tablet · Oral | KVK-Tech, Inc. | 10702-0278-03 |
| Leflunomide | LEFLUNOMIDE 10 mg/1 | Tablet · Oral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-0043-03 |
| Leflunomide | LEFLUNOMIDE 20 mg/1 | Tablet · Oral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-0044-03 |
| Leflunomide | LEFLUNOMIDE 10 mg/1 | Tablet, Film Coated · Oral | Burel Pharmaceuticals, LLC | 35573-0447-30 |
| Leflunomide | LEFLUNOMIDE 20 mg/1 | Tablet, Film Coated · Oral | Burel Pharmaceuticals, LLC | 35573-0448-30 |
| Leflunomide | LEFLUNOMIDE 10 mg/1 | Tablet · Oral | AvKARE | 42291-0420-30 |
| Leflunomide | LEFLUNOMIDE 20 mg/1 | Tablet · Oral | AvKARE | 42291-0421-30 |
| Leflunomide | LEFLUNOMIDE 20 mg/1 | Tablet, Film Coated · Oral | A-S Medication Solutions | 50090-5992-00 |
| Leflunomide | LEFLUNOMIDE 10 mg/1 | Tablet · Oral | AvPAK | 50268-0477-15 |
| Leflunomide | LEFLUNOMIDE 20 mg/1 | Tablet · Oral | AvPAK | 50268-0478-15 |
| Leflunomide | LEFLUNOMIDE 10 mg/1 | Tablet, Film Coated · Oral | Aurobindo Pharma Limited | 59651-0348-30 |
Alternative dosage forms of Leflunomide
A different form of the same drug (for example a solution when capsules are short). A form change is a clinical decision — ask your prescriber:
Therapeutic equivalents & pricing 30 productsclick to expand
Orange Book–rated equivalents of the affected strengths, with the latest NADAC price (a federal retail-acquisition benchmark, not your copay) and an evidence-based availability label. Cheapest first.
| Product | Manufacturer | Package | NADAC $/unit | AB rating | Availability |
|---|---|---|---|---|---|
| leflunomide 20 mg | Heritage | 30 tablets | $0.294 | AB | Availability likely |
| Leflunomide 20 mg | Burel | 30 tablets | $0.294 | AB | Availability likely |
| Leflunomide 20 mg | AvPAK | 50 tablets | $0.294 | AB | Availability likely |
| Leflunomide 20 mg | Aurobindo | 30 tablets | $0.294 | AB | Availability likely |
| Leflunomide 20 mg | Apotex | 30 tablets | $0.294 | AB | Availability likely |
| Leflunomide 20 mg | Chartwell | 30 tablets | $0.294 | AB | Availability likely |
| Leflunomide 20 mg | Alembic | 30 tablets | $0.294 | AB | Availability likely |
| Leflunomide 20 mg | Lupin | 30 tablets | $0.294 | AB | Availability likely |
| leflunomide 10 mg | Heritage | 30 tablets | $0.324 | AB | Availability likely |
| Leflunomide 10 mg | Burel | 30 tablets | $0.324 | AB | Availability likely |
| Leflunomide 10 mg | AvPAK | 50 tablets | $0.324 | AB | Availability likely |
| Leflunomide 10 mg | Aurobindo | 30 tablets | $0.324 | AB | Availability likely |
| Leflunomide 10 mg | Apotex | 30 tablets | $0.324 | AB | Availability likely |
| Leflunomide 10 mg | Chartwell | 30 tablets | $0.324 | AB | Availability likely |
| Leflunomide 10 mg | Alembic | 30 tablets | $0.324 | AB | Availability likely |
| Leflunomide 10 mg | Lupin | 30 tablets | $0.324 | AB | Availability likely |
| Leflunomide 10 mg | KVK-Tech, | 30 tablets | $0.413 | AB | FDA listed |
| Leflunomide 20 mg | Winthrop | 30 tablets | $0.417 | AB | Discontinued |
| Leflunomide 20 mg | KVK-Tech, | 30 tablets | $0.549 | AB | FDA listed |
| Arava 20 mg | sanofi-aventis | 30 tablets | — | AB | FDA listed |
| Leflunomide 20 mg | AvKARE | 30 tablets | — | AB | FDA listed |
| Leflunomide 20 mg | Alembic | 30 tablets | — | AB | FDA listed |
| Leflunomide 20 mg | A-S | 30 tablets | — | AB | FDA listed |
| leflunomide 20 mg | A-S | 30 tablets | — | AB | FDA listed |
| leflunomide 20 mg | NuCare | 90 tablets | — | AB | FDA listed |
| leflunomide 20 mg | Zydus | 100 tablets | — | AB | FDA listed |
| leflunomide 20 mg | Zydus | 100 tablets | — | AB | FDA listed |
| Leflunomide 20 mg | Bryant | 30 tablets | — | AB | FDA listed |
| leflunomide 20 mg | Bryant | 30 tablets | — | AB | FDA listed |
| leflunomide 20 mg | Bryant | 30 tablets | — | AB | FDA listed |
Equivalents share the same ingredient, strength, dosage form and route; an AB rating means the FDA considers them substitutable. NADAC is a national retail-pharmacy acquisition benchmark from CMS — not what you pay. Availability is inferred from recent pricing, not a stock check.
Other drugs in the same treatment class
These are different medicines — not other versions of Leflunomide Tablet — that fall in the same broad treatment class (anti-inflammatory, pyrimidine synthesis inhibitor) . They are not automatic substitutes: they can differ in how they work, dosing, effectiveness, side effects and what they’re approved to treat. Do not switch on your own. This list is for information only — ask your prescriber or pharmacist whether any of them is appropriate for you.
Identity & classification
Where does this data come from?
Other rheumatology shortages
Leflunomide Tablet shortage FAQs
Is Leflunomide Tablet in shortage?
Which products are affected?
When will Leflunomide Tablet be available again?
Can I still get Leflunomide somewhere?
What should I do if I take Leflunomide Tablet?
Still have a question about the Leflunomide Tablet shortage?
Ask a pharmacist about this shortage →View Leflunomide Tablet on the FDA drug-shortage database →
Where does this data come from?
/drug/shortages) — drug, manufacturer & contact, NDC/product, status, availability, reason, therapeutic category and posting/update dates. Current / To Be Discontinued = active; Resolved is kept for history. The Supply-Risk rating is assessed per active ingredient and adds the FDA NDC Directory (still-marketed manufacturers by ingredient & form); same-medicine and equivalent products use First Databank classification + CMS NADAC pricing; Medicaid use + most-affected states come from CMS Medicaid State Drug Utilization Data. Reference only — confirm current status with the manufacturer or FDA before acting on it.