Opdivo Purple Book BLA 125554
- BLA number
- 125554
- Proprietary names
- Opdivo
- Proper names
- nivolumab
- 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 | Opdivo | nivolumab | 351(a) | 40MG/4ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2014-12-22 | |
| 002 | Opdivo | nivolumab | 351(a) | 100MG/10ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2014-12-22 | |
| 003 | Opdivo | nivolumab | 351(a) | 240MG/24ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2017-10-04 | |
| 004 | Opdivo | nivolumab | 351(a) | 120MG/12ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2021-08-27 | |
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 |
|---|
| 2025-08-01 | U | 001 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2025-08-01 | U | 002 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2025-08-01 | U | 003 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2025-08-01 | U | 004 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2024-01-01 | U | 001 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2024-01-01 | U | 002 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2024-01-01 | U | 003 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2024-01-01 | U | 004 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2023-04-01 | U | 001 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2023-04-01 | U | 002 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2023-04-01 | U | 003 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2023-04-01 | U | 004 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2022-05-01 | U | 001 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2022-05-01 | U | 002 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2022-05-01 | U | 003 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2022-05-01 | U | 004 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2022-02-01 | U | 004 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2021-07-01 | U | 001 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2021-07-01 | U | 002 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2021-07-01 | U | 003 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2021-05-01 | U | 001 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2021-05-01 | U | 002 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2021-05-01 | U | 003 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2021-03-01 | U | 001 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2021-03-01 | U | 002 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2021-03-01 | U | 003 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2020-09-01 | U | 001 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2020-09-01 | U | 002 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2020-09-01 | U | 003 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2020-08-01 | U | 001 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2020-08-01 | U | 002 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2020-08-01 | U | 003 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2020-05-01 | R | 001 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2020-05-01 | R | 002 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2020-05-01 | R | 003 | Opdivo | 351(a) | Rx | Bristol-Myers Squibb Company |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2022-02-01 | 004 | Opdivo | 351(a) | Rx | Licensed | 2021-08-27 |
| 2020-05-01 | 001 | Opdivo | 351(a) | Rx | Licensed | 2014-12-22 |
| 2020-05-01 | 002 | Opdivo | 351(a) | Rx | Licensed | 2014-12-22 |
| 2020-05-01 | 003 | Opdivo | 351(a) | Rx | Licensed | 2017-10-04 |