Idacio Purple Book BLA 761255
- BLA number
- 761255
- Proprietary names
- Idacio
- Proper names
- adalimumab-aacf
- Applicant
- Fresenius Kabi USA, LLC
- Center
- CDER
- First observed release
- 2022-12-01
- 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 | Idacio | adalimumab-aacf | 351(k) Biosimilar | 40MG/0.8ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2022-12-13 | |
| 002 | Idacio | adalimumab-aacf | 351(k) Biosimilar | 40MG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2022-12-13 | |
| 003 | Idacio | adalimumab-aacf | 351(k) Biosimilar | 40MG/0.8ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | 2024-01-05 | |
Reference Biological Product#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125057 | Humira | adalimumab | 351(a) | Rx | 2026-06-01 |
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 |
|---|
| 2024-01-01 | N | 003 | Idacio | 351(k) Biosimilar | Rx | Fresenius Kabi USA, LLC |
| 2022-12-01 | N | 001 | Idacio | 351(k) Biosimilar | Rx | Fresenius Kabi USA, LLC |
| 2022-12-01 | N | 002 | Idacio | 351(k) Biosimilar | Rx | Fresenius Kabi USA, LLC |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2024-01-01 | 003 | Idacio | 351(k) Biosimilar | Rx | Licensed | 2024-01-05 |
| 2022-12-01 | 001 | Idacio | 351(k) Biosimilar | Rx | Licensed | 2022-12-13 |
| 2022-12-01 | 002 | Idacio | 351(k) Biosimilar | Rx | Licensed | 2022-12-13 |