FDA.reportPublic FDA data

Rixubis Purple Book BLA 125446

BLA number
125446
Proprietary names
Rixubis
Proper names
Coagulation Factor IX (Recombinant)
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Center
CBER
First observed release
2020-08-01
Latest observed release
2026-06-01
Newest archive release
2026-06-01
FDA patent list
No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage
Present in newest release

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
ProductProprietary nameProper nameLicense typeStrengthDosage formRoutePresentationMarketingLicensureApprovalPatent list provided
001RixubisCoagulation Factor IX (Recombinant)351(a)500IUFor InjectionIntravenousSingle-Dose VialRxLicensed2013-06-26
002RixubisCoagulation Factor IX (Recombinant)351(a)1000IUFor InjectionIntravenousSingle-Dose VialRxLicensed2013-06-26
003RixubisCoagulation Factor IX (Recombinant)351(a)250IUFor InjectionIntravenousSingle-Dose VialRxLicensed2013-06-26
004RixubisCoagulation Factor IX (Recombinant)351(a)3000IUFor InjectionIntravenousSingle-Dose VialRxLicensed2013-06-26
005RixubisCoagulation Factor IX (Recombinant)351(a)2000IUFor InjectionIntravenousSingle-Dose VialRxLicensed2013-06-26

Published Patent List#

No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.

Official Monthly Change Events#

Release, Event, Product table
ReleaseEventProductNameLicense typeStatusApplicant
2023-05-01U001Rixubis351(a)RxTakeda Pharmaceuticals U.S.A., Inc.
2023-05-01U002Rixubis351(a)RxTakeda Pharmaceuticals U.S.A., Inc.
2023-05-01U003Rixubis351(a)RxTakeda Pharmaceuticals U.S.A., Inc.
2023-05-01U004Rixubis351(a)RxTakeda Pharmaceuticals U.S.A., Inc.
2023-05-01U005Rixubis351(a)RxTakeda Pharmaceuticals U.S.A., Inc.
2021-09-01U001Rixubis351(a)RxBaxalta US Inc.
2021-09-01U002Rixubis351(a)RxBaxalta US Inc.
2021-09-01U003Rixubis351(a)RxBaxalta US Inc.
2021-09-01U004Rixubis351(a)RxBaxalta US Inc.
2021-09-01U005Rixubis351(a)RxBaxalta US Inc.
2021-05-01U001Rixubis351(a)RxBaxalta US Inc.
2021-05-01U002Rixubis351(a)RxBaxalta US Inc.
2021-05-01U003Rixubis351(a)RxBaxalta US Inc.
2021-05-01U004Rixubis351(a)RxBaxalta US Inc.
2021-05-01U005Rixubis351(a)RxBaxalta US Inc.
2020-08-01R001Rixubis351(a)RxBaxalta US Inc.
2020-08-01R002Rixubis351(a)RxBaxalta US Inc.
2020-08-01R003Rixubis351(a)RxBaxalta US Inc.
2020-08-01R004Rixubis351(a)RxBaxalta US Inc.
2020-08-01R005Rixubis351(a)RxBaxalta US Inc.

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2020-08-01001Rixubis351(a)RxLicensed2013-06-26
2020-08-01002Rixubis351(a)RxLicensed2013-06-26
2020-08-01003Rixubis351(a)RxLicensed2013-06-26
2020-08-01004Rixubis351(a)RxLicensed2013-06-26
2020-08-01005Rixubis351(a)RxLicensed2013-06-26