CLADRIBINE INJECTION 1 MG — DIN 02319918
CLADRIBINE : 1 MG · FRESENIUS KABI CANADA LTD · SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is CLADRIBINE INJECTION?
CLADRIBINE INJECTION 1 MG contains CLADRIBINE : 1 MG. It is listed in the Health Canada Drug Product Database under DIN 02319918, held by FRESENIUS KABI CANADA LTD, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 22-Aug-2016. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is CLADRIBINE INJECTION used for?
Cladribine Injection is indicated for treatment of patients with Hairy Cell Leukemia. It should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Cladribine cost around the world?
Cladribine is listed on 11 of the national price registers Nexara ingests. Each country publishes on a different basis, so those figures are not comparable with one another — or with a Canadian wholesale price.
What a market publishes matters more than the number it publishes. Australia publishes a ex-manufacturer; Austria publishes a KVP (Kassenverkaufspreis); Bahrain publishes a retail (max). 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 | Range |
|---|---|---|---|---|
| Australia | ex-manufacturer | 4 | 10 | AUD███.██ |
| Saudi Arabia | public | 3 | 5 | SAR███.██ |
| Bahrain | retail (max) | 2 | 4 | BHD███.██ |
| Czechia | max producer price (ex-factory) | 2 | 4 | CZK███.██ |
| Iceland | max wholesale | 2 | 4 | ISK███.██ |
| Austria | KVP (Kassenverkaufspreis) | 1 | 3 | EUR███.██ |
| Greece | producer price (ex-factory) | 3 | 3 | EUR███.██ |
| Hungary | producer price (ex-factory) | 1 | 3 | HUF███.██ |
| Luxembourg | reimbursement | 3 | 3 | EUR███.██ |
| United Arab Emirates | public | 1 | 2 | AED███.██ |
| South Africa | single exit price | 2 | 2 | ZAR███.██ |
43 pack listings across 24 brand entries and 9 price bases, refreshed 08 Sep 2026. Ranges span every Cladribine 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 Cladribine 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.
3 holders have a Canadian DIN containing Cladribine, across 3 DINs, of which 2 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 |
|---|---|---|---|---|
| FRESENIUS KABI CANADA LTD | 1 | 1 | CLADRIBINE INJECTION | Sourceable in Canada |
| GENERIC MEDICAL PARTNERS INC | 1 | 1 | CLADRIBINE INJECTION | Sourceable in Canada |
| JANSSEN INC | 1 | 0 | LEUSTATIN 1MG/ML | 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 | 1 MG |
|---|---|
| Dosage form | SOLUTION |
| Route | INTRAVENOUS |
| Pack configuration (monograph) | null |
| Storage | null |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Cladribine |
|---|---|
| ATC code | L01BB04 |
| AHFS class | 92:24.00 |
| 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) | 02319918 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2319918 |
| Brand name | CLADRIBINE INJECTION |
| Generic / active ingredient | CLADRIBINE : 1 MG |
| Market authorization holder | FRESENIUS KABI CANADA LTD |
| Health Canada schedule | Prescription |
| ATC code | L01BB04 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L01BB |
| Current status | MARKETED |
| Status date | 22-Aug-2016 |
| Original market date | 2010-07-27 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
Is Cladribine in shortage in Canada?
A Canadian shortage report is on file for a product containing this molecule: Resolved — reported by GENERIC MEDICAL PARTNERS INC, last seen 19 Mar 2026. A shortage on one presentation does not always affect every DIN of the molecule — the alternatives below list what else is marketed in Canada. Nexara can confirm current availability and identify substitutions or import options where permitted.
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
2 of 3 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| CLADRIBINE INJECTION | 1 MG | SOLUTION | GENERIC MEDICAL PARTNERS INC | MARKETED | 02494574 |
| LEUSTATIN 1MG/ML | 1 MG | SOLUTION | JANSSEN INC | CANCELLED POST MARKET | 02022117 |
2 · Same class — other molecules in ATC L01BB
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Fludarabine | AJ-FLUDARABINE · FLUDARA · FLUDARABINE PHOSPHATE FOR INJECTION · FLUDARABINE PHOSPHATE FOR INJECTION USP · +2 more | 10 | 3 | Yes |
| Cladribine | CLADRIBINE INJECTION · LEUSTATIN 1MG/ML | 3 | 2 | Yes |
| Mercaptopurine | MERCAPTOPURINE TABLETS USP · PURINETHOL | 2 | 2 | Yes |
| Clofarabine | CLOLAR | 1 | 1 | Yes |
| Nelarabine | ATRIANCE | 1 | 1 | Yes |
| Tioguanine | LANVIS | 1 | 1 | 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 L01B
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| L01BA | Methotrexate · Pemetrexed · Pralatrexate% · Raltitrexed | 90 | 36 |
| L01BC | Azacitidine · Capecitabine · Cytarabine · Decitabine · Decitabine, Combinations · +4 more | 112 | 34 |
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 CLADRIBINE INJECTION called?
Also recorded in Canada as: {9 (cladribine 10 MG Oral Tablet [Mavenclad]) } Pack [Mavenclad 9 Tablet Pack] (US), {8 (cladribine 10 MG Oral Tablet [Mavenclad]) } Pack [Mavenclad 8 Tablet Pack] (US), {7 (cladribine 10 MG Oral Tablet [Mavenclad]) } Pack [Mavenclad 7 Tablet Pack] (US), {6 (cladribine 10 MG Oral Tablet [Mavenclad]) } Pack [Mavenclad 6 Tablet Pack] (US), {5 (cladribine 10 MG Oral Tablet [Mavenclad]) } Pack [Mavenclad 5 Tablet Pack] (US), {4 (cladribine 10 MG Oral Tablet [Mavenclad]) } Pack [Mavenclad 4 Tablet Pack] (US), {10 (cladribine 10 MG Oral Tablet [Mavenclad]) } Pack [Mavenclad 10 Tablet Pack] (US), {9 (cladribine 10 MG Oral Tablet) } Pack (US), {8 (cladribine 10 MG Oral Tablet) } Pack (US), {7 (cladribine 10 MG Oral Tablet) } Pack (US), {6 (cladribine 10 MG Oral Tablet) } Pack (US), {5 (cladribine 10 MG Oral Tablet) } Pack (US), {4 (cladribine 10 MG Oral Tablet) } Pack (US), {10 (cladribine 10 MG Oral Tablet) } Pack (US), cladribine 10 MG Oral Tablet [Mavenclad] (US).
The same molecule, Cladribine, 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 |
|---|---|---|
| Mavenclad | Latin | Australia, Bahrain, Czechia, Iceland, Saudi Arabia |
| Clodreb | Latin | Bahrain, Saudi Arabia |
| CLADRITAB | Latin | Australia |
| Leustatin | Latin | Australia, Iceland |
| Litak | Latin | Australia, Czechia |
| Cladribine Atnahs | Latin | Saudi Arabia |
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.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
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.