PMS-LEFLUNOMIDE 20 MG — DIN 02288273
LEFLUNOMIDE : 20 MG · PHARMASCIENCE INC · TABLET · wholesale supply in Canada
Health Canada status: DORMANT
What is PMS-LEFLUNOMIDE?
PMS-LEFLUNOMIDE 20 MG contains LEFLUNOMIDE : 20 MG. It is listed in the Health Canada Drug Product Database under DIN 02288273, held by PHARMASCIENCE INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as dormant, status dated 02-Aug-2018. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A). This DIN is not currently being marketed in Canada, so it is sourced to order where a compliant route exists rather than held in stock.
What is PMS-LEFLUNOMIDE used for?
Indicated in adults for the treatment of active rheumatoid arthritis.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Leflunomide cost around the world?
Leflunomide is listed on 2 of the national price registers Nexara ingests. Each country publishes on a different basis, so figures are not comparable with one another — or with a Canadian wholesale price.
What a market publishes matters more than the number it publishes. Austria publishes a KVP (Kassenverkaufspreis); Czechia publishes a max producer price (ex-factory). Comparing an ex-factory ceiling against a pharmacy public price tells you nothing about either, and comparing either against a Canadian landed cost tells you less.
| Market | Price basis published there | Brands | Packs listed |
|---|---|---|---|
| Czechia | max producer price (ex-factory) | 6 | 11 |
| Austria | KVP (Kassenverkaufspreis) | 4 | 4 |
15 pack listings across 10 brand entries and 2 price bases, refreshed 03 Sep 2026. Ranges span every Leflunomide pack in that market, so a high figure is usually a larger pack rather than the same product.
Canada publishes no comparable public list price. For a delivered Canadian price on a licensed account, verify your licence — it takes about a minute.
Is there a generic Leflunomide in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
15 holders have a Canadian DIN containing Leflunomide, across 33 DINs, of which 18 are currently marketed. Marketed count is the number that matters: an approval that is not marketed cannot be bought.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| TEVA CANADA LIMITED | 4 | 2 | NTP-LEFLUNOMIDE, TEVA-LEFLUNOMIDE | Sourceable in Canada |
| SANOFI-AVENTIS CANADA INC | 3 | 2 | ARAVA | Sourceable in Canada |
| ACCEL PHARMA INC | 2 | 2 | ACCEL-LEFLUNOMIDE | Sourceable in Canada |
| APOTEX INC | 2 | 2 | APO-LEFLUNOMIDE | Sourceable in Canada |
| MARCAN PHARMACEUTICALS INC | 2 | 2 | MAR-LEFLUNOMIDE | Sourceable in Canada |
| PRO DOC LIMITEE | 2 | 2 | LEFLUNOMIDE | Sourceable in Canada |
| SANDOZ CANADA INCORPORATED | 2 | 2 | SANDOZ LEFLUNOMIDE | Sourceable in Canada |
| SANIS HEALTH INC | 2 | 2 | LEFLUNOMIDE | Sourceable in Canada |
| SIVEM PHARMACEUTICALS ULC | 2 | 2 | LEFLUNOMIDE | Sourceable in Canada |
| DOMINION PHARMACAL | 2 | 0 | DOM-LEFLUNOMIDE | No marketed DIN |
| MYLAN PHARMACEUTICALS ULC 85 Advance Road Etobicoke Ontario Canada M8Z 2S6 | 2 | 0 | MYLAN-LEFLUNOMIDE | No marketed DIN |
| NU-PHARM INC | 2 | 0 | NU-LEFLUNOMIDE | No marketed DIN |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 20 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Pack configuration (monograph) | Not explicitly detailed in the provided text (mentions 10 mg and 20 mg strengths). |
| Storage | Not explicitly detailed in the provided text (Table of Contents points to page 27, but text ends earlier). |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Leflunomide |
|---|---|
| ATC code | L04AK01 |
| AHFS class | 90:24.04 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02288273 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2288273 |
| Brand name | PMS-LEFLUNOMIDE |
| Generic / active ingredient | LEFLUNOMIDE : 20 MG |
| Market authorization holder | PHARMASCIENCE INC |
| Health Canada schedule | Prescription |
| ATC code | L04AK01 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L04AK |
| Current status | DORMANT |
| Status date | 02-Aug-2018 |
| Original market date | 2006-12-01 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Treatment of active rheumatoid arthritis in adults. Loading dose often used (though not detailed in snippet), followed by maintenance doses of 10 mg or 20 mg daily.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to leflunomide or teriflunomide; impaired liver function; immunodeficiency; impaired bone marrow function; serious infections; moderate to severe renal insufficiency; pregnancy.
Warnings and precautions
Risk of severe liver injury, potential for immunosuppression/serious infections, interstitial lung disease, peripheral neuropathy, and severe skin reactions (Stevens-Johnson syndrome).
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
1 · Same molecule, other Canadian presentations
18 of 33 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| ACCEL-LEFLUNOMIDE | 10 MG | TABLET | ACCEL PHARMA INC | MARKETED | 02478862 |
| ACCEL-LEFLUNOMIDE | 20 MG | TABLET | ACCEL PHARMA INC | MARKETED | 02478870 |
| APO-LEFLUNOMIDE | 10 MG | TABLET | APOTEX INC | MARKETED | 02256495 |
| APO-LEFLUNOMIDE | 20 MG | TABLET | APOTEX INC | MARKETED | 02256509 |
| ARAVA | 10 MG | TABLET | SANOFI-AVENTIS CANADA INC | MARKETED | 02241888 |
| ARAVA | 20 MG | TABLET | SANOFI-AVENTIS CANADA INC | MARKETED | 02241889 |
| LEFLUNOMIDE | 20 MG | TABLET | SANIS HEALTH INC | MARKETED | 02351676 |
| LEFLUNOMIDE | 10 MG | TABLET | PRO DOC LIMITEE | MARKETED | 02415828 |
| LEFLUNOMIDE | 20 MG | TABLET | PRO DOC LIMITEE | MARKETED | 02415836 |
| LEFLUNOMIDE | 10 MG | TABLET | SANIS HEALTH INC | MARKETED | 02351668 |
2 · Same class — other molecules in ATC L04AK
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Leflunomide | ACCEL-LEFLUNOMIDE · APO-LEFLUNOMIDE · ARAVA · DOM-LEFLUNOMIDE · +10 more | 33 | 18 | Yes |
| Teriflunomide | ACH-TERIFLUNOMIDE · APO-TERIFLUNOMIDE · AUBAGIO · AURO-TERIFLUNOMIDE · +7 more | 11 | 7 | Yes |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC L04A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| L04AX | Azathioprine · Dimethyl Fumarate · Lenalidomide · Methotrexate · Other Immunosuppressants · +3 more | 191 | 124 |
| L04AC | Anakinra · Basiliximab · Bimekizumab · Brodalumab · Canakinumab · +13 more | 85 | 75 |
| L04AB | Adalimumab · Certolizumab Pegol · Etanercept · Golimumab · Infliximab | 71 | 55 |
| L04AA | Abatacept · Alefacept · Antilymphocyte Immunoglobulin (Horse) · Antithymocyte Immunoglobulin (Rabbit) · Apremilast · +4 more | 73 | 42 |
| L04AD | Ciclosporin · Tacrolimus | 49 | 30 |
| L04AH | Everolimus · Sirolimus | 36 | 23 |
| L04AF | Baricitinib · Deucravacitinib · Ritlecitinib · Tofacitinib · Upadacitinib | 23 | 19 |
| L04AG | Alemtuzumab · Anifrolumab · Belimumab · Efalizumab · Inebilizumab · +7 more | 20 | 15 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
What else is PMS-LEFLUNOMIDE called?
The same molecule, Leflunomide, is registered under other names elsewhere. Buyers and prescribers searching from outside Canada — or working from a foreign prescription or tender document — often know it by one of these:
| Name | Script | Registered in |
|---|---|---|
| LEFLUNOMIDE MEDAC | Latin | Czechia |
| LEFLUNOPHARM | Latin | Czechia |
| LEFLUGEN | Latin | Czechia |
| ARAVA | Latin | Czechia |
| LEFLON | Latin | Czechia |
| LEFLUNOMID SANDOZ | Latin | Czechia |
Names are taken from national medicine registers and published price lists. A product registered abroad is not authorized for sale in Canada unless it holds its own DIN; import is possible only through the routes Health Canada permits.
What is Leflunomide called in other languages?
Buyers, prescribers and procurement teams outside Canada often search for the ingredient in their own script. These are phonetic renderings of the ingredient name Leflunomide, published to help those searches reach this page.
| Language | Leflunomide |
|---|---|
| Arabic العربية | ليفلونوميد |
| Chinese (Simplified) 简体中文 | 来氟米特 |
| Russian Русский | Лефлуномид |
| Spanish Español | Leflunomida |
| French Français | Leflunomide |
| Portuguese Português | Leflunomida |
| German Deutsch | Leflunomid |
| Japanese 日本語 | レフルノミド |
These are transliterations of the ingredient name, generated automatically and published only where two independent checks agreed. They are not registered local trade names and carry no marketing authorisation in any market. Always confirm a product against its local registration before ordering.
How can I get it?
This DIN is dormant — it holds a Health Canada authorization but is not currently being marketed in Canada, so it cannot simply be ordered from Canadian stock. Where a patient need exists, supply may be possible through exceptional importation or the Special Access Programme, subject to Health Canada's requirements and the prescriber's application. Nexara can advise on the route and on marketed alternatives.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address. Patients and unlicensed buyers are routed to a partner pharmacy.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.