APO-TOFACITINIB 5 MG — DIN 02538253
TOFACITINIB (TOFACITINIB CITRATE) : 5 MG · APOTEX INC · TABLET · wholesale supply in Canada
Health Canada status: APPROVED
What is APO-TOFACITINIB?
APO-TOFACITINIB 5 MG contains TOFACITINIB (TOFACITINIB CITRATE) : 5 MG. It is listed in the Health Canada Drug Product Database under DIN 02538253, held by APOTEX INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as approved, status dated 19-May-2023. 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.
How much does Tofacitinib cost around the world?
Tofacitinib is listed on 12 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; Bahrain publishes a retail (max); Greece publishes a 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 | Range |
|---|---|---|---|---|
| Australia | ex-manufacturer | 1 | 15 | AUD███.██ |
| Saudi Arabia | public | 7 | 11 | SAR███.██ |
| United States | acquisition | 1 | 7 | USD███.██ |
| Luxembourg | reimbursement | 6 | 6 | EUR███.██ |
| Iceland | max wholesale | 1 | 5 | ISK███.██ |
| Greece | producer price (ex-factory) | 4 | 4 | EUR███.██ |
| Italy | ex-factory (classe H) | 4 | 4 | EUR███.██ |
| Romania | max producer price | 3 | 4 | RON███.██ |
| Hungary | producer price (ex-factory) | 3 | 3 | HUF███.██ |
| South Africa | single exit price | 3 | 3 | ZAR███.██ |
| Slovakia | categorised final price | 2 | 2 | EUR███.██ |
| Bahrain | retail (max) | 1 | 1 | BHD███.██ |
65 pack listings across 36 brand entries and 11 price bases, refreshed 08 Sep 2026. Ranges span every Tofacitinib 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 Tofacitinib 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.
8 holders have a Canadian DIN containing Tofacitinib, across 16 DINs, of which 12 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 |
|---|---|---|---|---|
| PFIZER CANADA ULC | 3 | 3 | XELJANZ, XELJANZ XR | Sourceable in Canada |
| TARO PHARMACEUTICALS INC | 3 | 3 | TARO-TOFACITINIB, TARO-TOFACITINIB XR | Sourceable in Canada |
| AURO PHARMA INC | 2 | 2 | AURO-TOFACITINIB | Sourceable in Canada |
| SANDOZ CANADA INCORPORATED | 2 | 2 | SANDOZ TOFACITINIB | Sourceable in Canada |
| JAMP PHARMA CORPORATION | 1 | 1 | JAMP TOFACITINIB | Sourceable in Canada |
| PHARMASCIENCE INC | 1 | 1 | PMS-TOFACITINIB | Sourceable in Canada |
| APOTEX INC | 2 | 0 | APO-TOFACITINIB | No marketed DIN |
| TEVA CANADA LIMITED | 2 | 0 | TEVA-TOFACITINIB | 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 | 5 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Tofacitinib |
|---|---|
| ATC code | L04AF01 |
| 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) | 02538253 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2538253 |
| Brand name | APO-TOFACITINIB |
| Generic / active ingredient | TOFACITINIB (TOFACITINIB CITRATE) : 5 MG |
| Market authorization holder | APOTEX INC |
| Health Canada schedule | Prescription |
| ATC code | L04AF01 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L04AF |
| Current status | APPROVED |
| Status date | 19-May-2023 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
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
12 of 16 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| AURO-TOFACITINIB | 10 MG | TABLET | AURO PHARMA INC | MARKETED | 02530015 |
| AURO-TOFACITINIB | 5 MG | TABLET | AURO PHARMA INC | MARKETED | 02530007 |
| JAMP TOFACITINIB | 5 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | 02522896 |
| PMS-TOFACITINIB | 5 MG | TABLET | PHARMASCIENCE INC | MARKETED | 02522799 |
| SANDOZ TOFACITINIB | 5 MG | TABLET | SANDOZ CANADA INCORPORATED | MARKETED | 02551691 |
| SANDOZ TOFACITINIB | 10 MG | TABLET | SANDOZ CANADA INCORPORATED | MARKETED | 02551705 |
| TARO-TOFACITINIB | 5 MG | TABLET | TARO PHARMACEUTICALS INC | MARKETED | 02511304 |
| TARO-TOFACITINIB | 10 MG | TABLET | TARO PHARMACEUTICALS INC | MARKETED | 02511312 |
| TARO-TOFACITINIB XR | 11 MG | TABLET (EXTENDED-RELEASE) | TARO PHARMACEUTICALS INC | MARKETED | 02553988 |
| XELJANZ | 10 MG | TABLET | PFIZER CANADA ULC | MARKETED | 02480786 |
2 · Same class — other molecules in ATC L04AF
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Tofacitinib | APO-TOFACITINIB · AURO-TOFACITINIB · JAMP TOFACITINIB · PMS-TOFACITINIB · +6 more | 16 | 12 | Yes |
| Upadacitinib | RINVOQ | 3 | 3 | Yes |
| Baricitinib | OLUMIANT | 2 | 2 | Yes |
| Deucravacitinib | SOTYKTU | 1 | 1 | Yes |
| Ritlecitinib | LITFULO | 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 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 |
| L04AK | Leflunomide · Teriflunomide | 44 | 25 |
| L04AH | Everolimus · Sirolimus | 36 | 23 |
| 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 APO-TOFACITINIB called?
The same molecule, Tofacitinib, 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 |
|---|---|---|
| Xeljanz | Latin | Australia, Iceland |
| Jakenz | Latin | Saudi Arabia |
| Timard | Latin | Saudi Arabia |
| Tofaci | Latin | Saudi Arabia |
| Trijan | Latin | Saudi Arabia |
| Tofanta | Latin | Saudi Arabia |
| XELJANZ XR | Latin | Bahrain |
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?
This product is approved by Health Canada but not yet marketed in Canada, so there is no Canadian supply to draw on today. Nexara can tell you whether it has been launched, and can look at supply from other markets where a Canadian pack is not required or where importation is 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.