Orencia Purple Book BLA 125118
- BLA number
- 125118
- Proprietary names
- Orencia
- Proper names
- abatacept
- Applicant
- Bristol-Myers Squibb Company
- Center
- CDER
- First observed release
- 2020-05-01
- 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 | Orencia | abatacept | 351(a) | 250MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2005-12-23 | |
| 002 | Orencia | abatacept | 351(a) | 125MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2011-07-29 | |
| 003 | Orencia | abatacept | 351(a) | 125MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2016-06-07 | |
| 004 | Orencia | abatacept | 351(a) | 50MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2017-03-30 | |
| 005 | Orencia | abatacept | 351(a) | 87.5MG/0.7ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2017-03-30 | |
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 |
|---|
| 2023-02-01 | U | 001 | Orencia | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2023-02-01 | U | 002 | Orencia | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2023-02-01 | U | 003 | Orencia | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2023-02-01 | U | 004 | Orencia | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2023-02-01 | U | 005 | Orencia | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2020-05-01 | R | 001 | Orencia | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2020-05-01 | R | 002 | Orencia | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2020-05-01 | R | 003 | Orencia | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2020-05-01 | R | 004 | Orencia | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2020-05-01 | R | 005 | Orencia | 351(a) | Rx | Bristol-Myers Squibb Company |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-05-01 | 001 | Orencia | 351(a) | Rx | Licensed | 2005-12-23 |
| 2020-05-01 | 002 | Orencia | 351(a) | Rx | Licensed | 2011-07-29 |
| 2020-05-01 | 003 | Orencia | 351(a) | Rx | Licensed | 2016-06-07 |
| 2020-05-01 | 004 | Orencia | 351(a) | Rx | Licensed | 2017-03-30 |
| 2020-05-01 | 005 | Orencia | 351(a) | Rx | Licensed | 2017-03-30 |