KOGENATE FS 1000 UNIT — DIN 02242491
ANTIHEMOPHILIC FACTOR (RECOMBINANT) : 1000 UNIT · BAYER INC · POWDER FOR SOLUTION · wholesale supply in Canada
Health Canada status: CANCELLED POST MARKET
What is KOGENATE FS?
KOGENATE FS 1000 UNIT contains ANTIHEMOPHILIC FACTOR (RECOMBINANT) : 1000 UNIT. It is listed in the Health Canada Drug Product Database under DIN 02242491, held by BAYER INC, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as cancelled post market, status dated 06-Aug-2009. This Drug Identification Number is no longer authorized for sale in Canada, so Nexara does not supply it. The record is kept here because buyers still meet the number on old formularies, purchase orders and tender documents; Nexara can help identify an authorized alternative.
What is KOGENATE FS used for?
Treatment of classical hemophilia (hemophilia A). Regular prophylactic treatment to prevent spontaneous hemorrhagic episodes and joint damage in children with no pre-existing joint damage.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
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 | 1000 UNIT |
|---|---|
| Dosage form | POWDER FOR SOLUTION |
| Route | INTRAVENOUS |
| Pack configuration (monograph) | Vials of 250, 500, 1000, or 2000 IU with 2.5 mL or 5.0 mL Sterile Water for Injection (diluent), transfer device, filter needle, and administration set. |
| Storage | Store under refrigeration (2-8°C). Do not freeze. Protect from light. Reconstituted product must be used within 3 hours. |
| Shipping class | Cold chain — validated shipper with temperature monitoring |
Pack detail is kept as a regulatory record. This DIN is no longer authorized for sale in Canada, so Nexara does not quote this pack.
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) | 02242491 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2242491 |
| Brand name | KOGENATE FS |
| Generic / active ingredient | ANTIHEMOPHILIC FACTOR (RECOMBINANT) : 1000 UNIT |
| Market authorization holder | BAYER INC |
| Health Canada schedule | Schedule D |
| ATC code | B02BD02 |
| ATC anatomical main group | B — Blood and blood-forming organs |
| ATC therapeutic subgroup | B02BD |
| Current status | CANCELLED POST MARKET |
| Status date | 06-Aug-2009 |
| Original market date | 2000-09-29 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Individualize dose based on FVIII deficiency severity, hemorrhage severity, and inhibitors. Administer IV within 3 hours of reconstitution. Prophylaxis in children: 25 IU/kg every other day.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to the drug, any ingredient in the formulation, or component of the container. Known hypersensitivity to mouse or hamster protein.
Warnings and precautions
Development of circulating neutralizing antibodies (inhibitors) to FVIII may occur. Risk of serious anaphylactic reactions. Potential for hypersensitivity to mouse/hamster proteins.
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 · +34 more | 134 | 38 | Yes |
| Coagulation Factor Ix | ALPHANINE PWS INJ 1500UNIT/VIAL · ALPROLIX · BEBULIN VH 500UNIT/VIAL · BEBULIN VH INJ 1000UNIT/VIAL · +8 more | 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 · +1 more | 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.
Can this still be bought in Canada?
No. This Drug Identification Number is cancelled post market in Health Canada's Drug Product Database, so the product is no longer authorized for sale in Canada and Nexara does not supply it. This page is kept as a regulatory record.
If you are looking for a current equivalent, the alternatives above list every product sharing this therapeutic class, with the marketed ones first. Ask us to source an alternative
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.