Benefix Purple Book BLA 103677
- BLA number
- 103677
- Proprietary names
- Benefix
- Proper names
- Coagulation Factor IX (Recombinant)
- Applicant
- Wyeth Pharmaceuticals LLC
- 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| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | Benefix | Coagulation Factor IX (Recombinant) | 351(a) | 1000IU/ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 1997-02-11 | |
| 002 | Benefix | Coagulation Factor IX (Recombinant) | 351(a) | 500IU/ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 1997-02-11 | |
| 003 | Benefix | Coagulation Factor IX (Recombinant) | 351(a) | 250IU/ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 1997-02-11 | |
| 004 | Benefix | Coagulation Factor IX (Recombinant) | 351(a) | 2000IU/ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2007-03-21 | |
| 005 | Benefix | Coagulation Factor IX (Recombinant) | 351(a) | 3000IU/ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2011-11-23 | |
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| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2023-06-01 | U | 001 | Benefix | 351(a) | Rx | Wyeth Pharmaceuticals LLC |
| 2023-06-01 | U | 002 | Benefix | 351(a) | Rx | Wyeth Pharmaceuticals LLC |
| 2023-06-01 | U | 003 | Benefix | 351(a) | Rx | Wyeth Pharmaceuticals LLC |
| 2023-06-01 | U | 004 | Benefix | 351(a) | Rx | Wyeth Pharmaceuticals LLC |
| 2023-06-01 | U | 005 | Benefix | 351(a) | Rx | Wyeth Pharmaceuticals LLC |
| 2023-02-01 | U | 001 | Benefix, Benefix Rts | 351(a) | Rx | Wyeth Pharmaceuticals LLC |
| 2023-02-01 | U | 002 | Benefix, Benefix Rts | 351(a) | Rx | Wyeth Pharmaceuticals LLC |
| 2023-02-01 | U | 003 | Benefix, Benefix Rts | 351(a) | Rx | Wyeth Pharmaceuticals LLC |
| 2023-02-01 | U | 004 | Benefix, Benefix Rts | 351(a) | Rx | Wyeth Pharmaceuticals LLC |
| 2023-02-01 | U | 005 | Benefix, Benefix Rts | 351(a) | Rx | Wyeth Pharmaceuticals LLC |
| 2021-05-01 | U | 001 | Benefix, Benefix Rts | 351(a) | Rx | Wyeth Pharmaceuticals LLC |
| 2021-05-01 | U | 002 | Benefix, Benefix Rts | 351(a) | Rx | Wyeth Pharmaceuticals LLC |
| 2021-05-01 | U | 003 | Benefix, Benefix Rts | 351(a) | Rx | Wyeth Pharmaceuticals LLC |
| 2021-05-01 | U | 004 | Benefix, Benefix Rts | 351(a) | Rx | Wyeth Pharmaceuticals LLC |
| 2021-05-01 | U | 005 | Benefix, Benefix Rts | 351(a) | Rx | Wyeth Pharmaceuticals LLC |
| 2020-08-01 | R | 001 | Benefix, Benefix Rts | 351(a) | Rx | Wyeth Pharmaceuticals LLC |
| 2020-08-01 | R | 002 | Benefix, Benefix Rts | 351(a) | Rx | Wyeth Pharmaceuticals LLC |
| 2020-08-01 | R | 003 | Benefix, Benefix Rts | 351(a) | Rx | Wyeth Pharmaceuticals LLC |
| 2020-08-01 | R | 004 | Benefix, Benefix Rts | 351(a) | Rx | Wyeth Pharmaceuticals LLC |
| 2020-08-01 | R | 005 | Benefix, Benefix Rts | 351(a) | Rx | Wyeth Pharmaceuticals LLC |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2023-06-01 | 001 | Benefix | 351(a) | Rx | Licensed | 1997-02-11 |
| 2023-06-01 | 002 | Benefix | 351(a) | Rx | Licensed | 1997-02-11 |
| 2023-06-01 | 003 | Benefix | 351(a) | Rx | Licensed | 1997-02-11 |
| 2023-06-01 | 004 | Benefix | 351(a) | Rx | Licensed | 2007-03-21 |
| 2023-06-01 | 005 | Benefix | 351(a) | Rx | Licensed | 2011-11-23 |
| 2020-08-01 | 001 | Benefix, Benefix Rts | 351(a) | Rx | Licensed | 1997-02-11 |
| 2020-08-01 | 002 | Benefix, Benefix Rts | 351(a) | Rx | Licensed | 1997-02-11 |
| 2020-08-01 | 003 | Benefix, Benefix Rts | 351(a) | Rx | Licensed | 1997-02-11 |
| 2020-08-01 | 004 | Benefix, Benefix Rts | 351(a) | Rx | Licensed | 2007-03-21 |
| 2020-08-01 | 005 | Benefix, Benefix Rts | 351(a) | Rx | Licensed | 2011-11-23 |