MedPath

Coagulation Factor IX (Recombinant)

Generic Name
Coagulation Factor IX (Recombinant)
Brand Names
Benefix, Idelvion, Ixinity, Rixubis, BeneFIX
Drug Type
Biotech
CAS Number
181054-95-5
Unique Ingredient Identifier
382L14738L

Overview

Recombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).

Indication

For treatment of hemophilia (Christmas disease).

Associated Conditions

  • Bleeding
  • Hemophilia B
  • Perioperative bleeding caused by Hemophilia B

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
BENEFIX factor IX recombinant 1000 IU powder for injection vial and diluent syringe composite pack
128377
Medicine
A
9/27/2007
Rixubis nonacog gamma (rch) 2000 IU powder and solvent for solution for injection glass vials
204768
Medicine
A
2/5/2014
BENEFIX factor IX recombinant 500 IU powder for injection vial and diluent syringe composite pack
128375
Medicine
A
9/27/2007
Rixubis nonacog gamma (rch) 3000 IU powder and solvent for solution for injection glass vials
204765
Medicine
A
2/5/2014
BENEFIX factor IX recombinant 3000 IU powder for injection vial and diluent syringe composite pack
203316
Medicine
A
8/20/2013
BENEFIX factor IX recombinant 250 IU powder for injection vial and diluent syringe composite pack
128339
Medicine
A
9/27/2007
Rixubis nonacog gamma (rch) 500 IU powder and solvent for solution for injection glass vials
204769
Medicine
A
2/5/2014
Rixubis nonacog gamma (rch) 1000 IU powder and solvent for solution for injection glass vials
204766
Medicine
A
2/5/2014
Rixubis nonacog gamma (rch) 250 IU powder and solvent for solution for injection glass vials
204767
Medicine
A
2/5/2014
BENEFIX factor IX recombinant 2000 IU powder for injection vial and diluent syringe composite pack
128378
Medicine
A
9/27/2007

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
RIXUBIS
takeda canada inc
02431963
Kit ,  Powder For Solution - Intravenous
3000 UNIT / VIAL
9/25/2018
BENEFIX
02392984
Powder For Solution - Intravenous
3000 UNIT / VIAL
2/12/2013
RIXUBIS
takeda canada inc
02431947
Kit ,  Powder For Solution - Intravenous
1000 UNIT / VIAL
4/18/2017
BENEFIX - (250IU)
wyeth canada
02231018
Kit ,  Powder For Solution ,  Liquid - Intravenous
250 UNIT / VIAL
8/12/1998
RIXUBIS
takeda canada inc
02431955
Kit ,  Powder For Solution - Intravenous
2000 UNIT / VIAL
4/18/2017
BENEFIX
02293803
Powder For Solution - Intravenous
2000 UNIT / VIAL
7/12/2008
BENEFIX
02466619
Powder For Solution - Intravenous
1500 UNIT / VIAL
N/A
BENEFIX - (500IU)
wyeth canada
02231019
Kit ,  Powder For Solution ,  Liquid - Intravenous
500 UNIT / VIAL
8/12/1998
BENEFIX
02293781
Powder For Solution - Intravenous
1000 UNIT / VIAL
4/14/2007
BENEFIX -(1000IU)
wyeth canada
02231020
Powder For Solution ,  Liquid ,  Kit - Intravenous
1000 UNIT / VIAL
8/12/1998

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
BENEFIX 3000 UI, POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE
197047008
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Uso Hospitalario
Commercialized
Rixubis 250UI/vial polvo y disolvente para solucion inyectable
114970001
POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE
Uso Hospitalario
Not Commercialized
Rixubis 2000UI/vial polvo y disolvente para solucion inyectable
114970004
POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE
Uso Hospitalario
Commercialized
BENEFIX 500 UI, POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE
97047005
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Uso Hospitalario
Commercialized
BENEFIX 2000 UI, POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE
97047007
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Uso Hospitalario
Commercialized
BENEFIX 250 UI, POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE
97047004
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Uso Hospitalario
Commercialized
Rixubis 500UI/vial polvo y disolvente para solucion inyectable
114970002
POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE
Uso Hospitalario
Not Commercialized
Rixubis 1000UI/vial polvo y disolvente para solucion inyectable
114970003
POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE
Uso Hospitalario
Commercialized
BENEFIX 1000 UI, POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE
97047006
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Uso Hospitalario
Commercialized
Rixubis 3000UI/vial polvo y disolvente para solucion inyectable
114970005
POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE
Uso Hospitalario
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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