Adynovate Purple Book BLA 125566
- BLA number
- 125566
- Proprietary names
- Adynovate
- Proper names
- Antihemophilic Factor (Recombinant), PEGylated
- 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| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | Adynovate | Antihemophilic Factor (Recombinant), PEGylated | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2015-11-13 | |
| 002 | Adynovate | Antihemophilic Factor (Recombinant), PEGylated | 351(a) | 2000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2015-11-13 | |
| 003 | Adynovate | Antihemophilic Factor (Recombinant), PEGylated | 351(a) | 250IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2015-11-13 | |
| 004 | Adynovate | Antihemophilic Factor (Recombinant), PEGylated | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2015-11-13 | |
| 005 | Adynovate | Antihemophilic Factor (Recombinant), PEGylated | 351(a) | 1500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2016-10-25 | |
| 006 | Adynovate | Antihemophilic Factor (Recombinant), PEGylated | 351(a) | 750IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2016-10-25 | |
| 007 | Adynovate | Antihemophilic Factor (Recombinant), PEGylated | 351(a) | 3000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2017-03-13 | |
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 |
|---|
| 2023-05-01 | U | 001 | Adynovate | 351(a) | Rx | Takeda Pharmaceuticals U.S.A., Inc. |
| 2023-05-01 | U | 002 | Adynovate | 351(a) | Rx | Takeda Pharmaceuticals U.S.A., Inc. |
| 2023-05-01 | U | 003 | Adynovate | 351(a) | Rx | Takeda Pharmaceuticals U.S.A., Inc. |
| 2023-05-01 | U | 004 | Adynovate | 351(a) | Rx | Takeda Pharmaceuticals U.S.A., Inc. |
| 2023-05-01 | U | 005 | Adynovate | 351(a) | Rx | Takeda Pharmaceuticals U.S.A., Inc. |
| 2023-05-01 | U | 006 | Adynovate | 351(a) | Rx | Takeda Pharmaceuticals U.S.A., Inc. |
| 2023-05-01 | U | 007 | Adynovate | 351(a) | Rx | Takeda Pharmaceuticals U.S.A., Inc. |
| 2021-05-01 | U | 001 | Adynovate | 351(a) | Rx | Baxalta US Inc. |
| 2021-05-01 | U | 002 | Adynovate | 351(a) | Rx | Baxalta US Inc. |
| 2021-05-01 | U | 003 | Adynovate | 351(a) | Rx | Baxalta US Inc. |
| 2021-05-01 | U | 004 | Adynovate | 351(a) | Rx | Baxalta US Inc. |
| 2021-05-01 | U | 005 | Adynovate | 351(a) | Rx | Baxalta US Inc. |
| 2021-05-01 | U | 006 | Adynovate | 351(a) | Rx | Baxalta US Inc. |
| 2021-05-01 | U | 007 | Adynovate | 351(a) | Rx | Baxalta US Inc. |
| 2020-08-01 | R | 001 | Adynovate | 351(a) | Rx | Baxalta US Inc. |
| 2020-08-01 | R | 002 | Adynovate | 351(a) | Rx | Baxalta US Inc. |
| 2020-08-01 | R | 003 | Adynovate | 351(a) | Rx | Baxalta US Inc. |
| 2020-08-01 | R | 004 | Adynovate | 351(a) | Rx | Baxalta US Inc. |
| 2020-08-01 | R | 005 | Adynovate | 351(a) | Rx | Baxalta US Inc. |
| 2020-08-01 | R | 006 | Adynovate | 351(a) | Rx | Baxalta US Inc. |
| 2020-08-01 | R | 007 | Adynovate | 351(a) | Rx | Baxalta US Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-08-01 | 001 | Adynovate | 351(a) | Rx | Licensed | 2015-11-13 |
| 2020-08-01 | 002 | Adynovate | 351(a) | Rx | Licensed | 2015-11-13 |
| 2020-08-01 | 003 | Adynovate | 351(a) | Rx | Licensed | 2015-11-13 |
| 2020-08-01 | 004 | Adynovate | 351(a) | Rx | Licensed | 2015-11-13 |
| 2020-08-01 | 005 | Adynovate | 351(a) | Rx | Licensed | 2016-10-25 |
| 2020-08-01 | 006 | Adynovate | 351(a) | Rx | Licensed | 2016-10-25 |
| 2020-08-01 | 007 | Adynovate | 351(a) | Rx | Licensed | 2017-03-13 |