XYNTHA 250 UNIT — DIN 02309483
MOROCTOCOG ALFA : 250 UNIT · PFIZER CANADA ULC · POWDER FOR SOLUTION ; KIT · wholesale supply in Canada
Health Canada status: MARKETED
What is XYNTHA?
XYNTHA 250 UNIT contains MOROCTOCOG ALFA : 250 UNIT. It is listed in the Health Canada Drug Product Database under DIN 02309483, held by PFIZER CANADA ULC, supplied as POWDER FOR SOLUTION ; KIT for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 17-Feb-2012. 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.
Is there a generic Coagulation Factor Viii 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.
19 holders have a Canadian DIN containing Coagulation Factor Viii, across 134 DINs, of which 38 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 |
|---|---|---|---|---|
| SANOFI-AVENTIS CANADA INC | 13 | 12 | ALTUVIIIO, ELOCTATE | Sourceable in Canada |
| BAYER INC | 28 | 9 | JIVI, KOGENATE FS, KOGENATE FS -(WITH BIO-SET), KOVALTRY | Sourceable in Canada |
| TAKEDA CANADA INC | 29 | 7 | ADVATE, ADYNOVATE, OBIZUR | Sourceable in Canada |
| PFIZER CANADA ULC | 9 | 6 | XYNTHA, XYNTHA SOLOFUSE | Sourceable in Canada |
| NOVO NORDISK CANADA INC | 11 | 4 | ESPEROCT, ZONOVATE | Sourceable in Canada |
| OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES M B H | 8 | 0 | NUWIQ | No marketed DIN |
| CSL BEHRING CANADA INC | 7 | 0 | AFSTYLA | No marketed DIN |
| BAXTER HEALTHCARE CORPORATION | 6 | 0 | ADVATE, HEMOFIL M, RECOMBINATE PWS INJ 1000I.U./VIAL, RECOMBINATE PWS INJ 250I.U./VIAL, RECOMBINATE PWS INJ 500I.U./VIAL | No marketed DIN |
| BAYER HEALTHCARE LLC | 5 | 0 | HELIXATE FS | No marketed DIN |
| BAYER CORPORATION | 4 | 0 | KOATE-HP - PWS IV 1000IU/VIAL, KOGENATE - PWS IV 1000I.U./VIAL, KOGENATE - PWS IV 250I.U./VIAL, KOGENATE - PWS IV 500I.U./VIAL | No marketed DIN |
| AVENTIS BEHRING LLC | 3 | 0 | MONOCLATE-P - 200-350IU/VIAL, MONOCLATE-P - 400-700IU/VIAL, MONOCLATE-P - 800-1500IU/VIAL | No marketed DIN |
| MILES INC. - PHARMACEUTICAL DIVISION | 3 | 0 | KOGENATE PWS 1000IU/VIAL, KOGENATE PWS 250IU/VIAL, KOGENATE PWS 500IU/VIAL | 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 | 250 UNIT |
|---|---|
| Dosage form | POWDER FOR SOLUTION ; KIT |
| Route | INTRAVENOUS |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Coagulation Factor Viii |
|---|---|
| ATC code | B02BD02 |
| AHFS class | 20:28.16 |
| 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) | 02309483 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2309483 |
| Brand name | XYNTHA |
| Generic / active ingredient | MOROCTOCOG ALFA : 250 UNIT |
| Market authorization holder | PFIZER CANADA ULC |
| Health Canada schedule | Schedule D |
| ATC code | B02BD02 |
| ATC anatomical main group | B — Blood and blood-forming organs |
| ATC therapeutic subgroup | B02BD |
| Current status | MARKETED |
| Status date | 17-Feb-2012 |
| Original market date | 2009-01-23 00:00:00 |
| 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
38 of 134 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| ADYNOVATE | 2000 UNIT | POWDER FOR SOLUTION ; KIT | TAKEDA CANADA INC | MARKETED | 02459078 |
| ADYNOVATE | 1000 UNIT | KIT ; POWDER FOR SOLUTION | TAKEDA CANADA INC | MARKETED | 02498588 |
| ADYNOVATE | 3000 UNIT | POWDER FOR SOLUTION ; KIT | TAKEDA CANADA INC | MARKETED | 02498626 |
| ADYNOVATE | 1500 UNIT | POWDER FOR SOLUTION ; KIT | TAKEDA CANADA INC | MARKETED | 02498596 |
| ADYNOVATE | 250 UNIT | KIT ; POWDER FOR SOLUTION | TAKEDA CANADA INC | MARKETED | 02498537 |
| ADYNOVATE | 500 UNIT | POWDER FOR SOLUTION ; KIT | TAKEDA CANADA INC | MARKETED | 02498545 |
| ALTUVIIIO | 4000 UNIT | POWDER FOR SOLUTION | SANOFI-AVENTIS CANADA INC | MARKETED | 02448157 |
| ALTUVIIIO | 1000 UNIT | POWDER FOR SOLUTION | SANOFI-AVENTIS CANADA INC | MARKETED | 02448130 |
| ALTUVIIIO | 3000 UNIT | POWDER FOR SOLUTION | SANOFI-AVENTIS CANADA INC | MARKETED | 02447967 |
| ALTUVIIIO | 500 UNIT | POWDER FOR SOLUTION | SANOFI-AVENTIS CANADA INC | MARKETED | 02448122 |
2 · Same class — other molecules in ATC B02BD
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Coagulation Factor Viii | ADVATE · ADYNOVATE · AFSTYLA · ALTUVIIIO · ELOCTATE · ESPEROCT · FACTORATE INJ 15UNIT/ML · HELIXATE FS · HEMOFIL M · HYATE C INJ VIAL · HYATE:C · JIVI · KOATE-HP - PWS IV 1000IU/VIAL · KOATE-HP UNJ · KOGENATE - PWS IV 1000I.U./VIAL · KOGENATE - PWS IV 250I.U./VIAL · KOGENATE - PWS IV 500I.U./VIAL · KOGENATE FS · KOGENATE FS -(WITH BIO-SET) · KOGENATE PWS 1000IU/VIAL · KOGENATE PWS 250IU/VIAL · KOGENATE PWS 500IU/VIAL · KOVALTRY · KRYOBULIN VH 1000 UNIT/VIAL · KRYOBULIN VH 500 UNIT/VIAL · MONOCLATE-P - 200-350IU/VIAL · MONOCLATE-P - 400-700IU/VIAL · MONOCLATE-P - 800-1500IU/VIAL · NUWIQ · OBIZUR · PROFILATE HEAT TREATED-WET METHOD INJ · RECOMBINATE PWS INJ 1000I.U./VIAL · RECOMBINATE PWS INJ 250I.U./VIAL · RECOMBINATE PWS INJ 500I.U./VIAL · REFACTO · XYNTHA · XYNTHA SOLOFUSE · ZONOVATE | 134 | 38 | Yes |
| Coagulation Factor Ix | ALPHANINE PWS INJ 1500UNIT/VIAL · ALPROLIX · BEBULIN VH 500UNIT/VIAL · BEBULIN VH INJ 1000UNIT/VIAL · BENEFIX · BENEFIX - (250IU) · BENEFIX - (500IU) · BENEFIX -(1000IU) · IDELVION · IMMUNINE VH · REBINYN · RIXUBIS | 33 | 16 | Yes |
| Von Willebrand Factor And Coag. Fact. Viii In Comb | ALPHANATE · HUMATE-P · WILATE | 10 | 5 | Yes |
| Coagulation Factor Ix, Ii, Vii And X In Comb | BERIPLEX P/N 1000 · BERIPLEX P/N 500 · OCTAPLEX | 4 | 4 | Yes |
| Coagulation Factor Viia | NIASTASE · NIASTASE RT | 11 | 3 | Yes |
| Factor Viii Inhibitor Bypassing Activity | FEIBA NF · FEIBA VH IMMUNO ANTI INHIBITOR | 5 | 2 | Yes |
| Coagulation Factor Xiii | CORIFACT 1250 · CORIFACT 250 | 2 | 2 | Yes |
| Thrombin | RECOTHROM · THROMBOGEN SPRAY KIT · VISTASEAL | 4 | 1 | Yes |
| Catridecacog | TRETTEN | 1 | 1 | Yes |
| Etranacogene Dezaparvovec | HEMGENIX | 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 B02B
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| B02BX | Avatrombopag · Concizumab · Eltrombopag · Emicizumab · Fostamatinib · Romiplostim | 23 | 15 |
| B02BC | Combinations · Epinephrine · Local Hemostatics · Thrombin | 23 | 6 |
| B02BA | Phytomenadione | 5 | 2 |
| B02BB | Fibrinogen, Human | 2 | 2 |
4 · Fixed-dose combinations with Canadian supply
| Product | Active ingredients | Holder | Status | DIN |
|---|---|---|---|---|
| ADYNOVATE | ANTIHEMOPHILIC FACTOR (RECOMBINANT), PEGYLATED : 1000 UNIT | TAKEDA CANADA INC | MARKETED | 02498588 |
| ALPROLIX | RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN : 500 UNIT | SANOFI-AVENTIS CANADA INC | MARKETED | 02422913 |
| ALTUVIIIO | *ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, BDD), FC-VWF-XTEN FUSION PROTEIN : 4000 UNIT | SANOFI-AVENTIS CANADA INC | MARKETED | 02448157 |
| ELOCTATE | ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN : 500 UNIT | SANOFI-AVENTIS CANADA INC | MARKETED | 02430304 |
| ESPEROCT | ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED : 2000 UNIT | NOVO NORDISK CANADA INC | MARKETED | 02490099 |
| JIVI | ANTIHEMOPHILIC FACTOR (RECOMBINANT, B-DOMAIN DELETED, PEGYLATED) : 1000 UNIT | BAYER INC | MARKETED | 02481774 |
| REBINYN | COAGULATION FACTOR IX (RECOMBINANT), PEGYLATED : 3000 UNIT | NOVO NORDISK CANADA INC | MARKETED | 02532964 |
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.
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.