Opdivo Qvantig Purple Book BLA 761381
- BLA number
- 761381
- Proprietary names
- Opdivo Qvantig
- Proper names
- nivolumab and hyaluronidase-nvhy
- Applicant
- Bristol-Myers Squibb Company
- Center
- CDER
- First observed release
- 2024-12-01
- 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 | Opdivo Qvantig | nivolumab and hyaluronidase-nvhy | 351(a) | 600MG/5ML;10,000UNITS/5ML (120MG/2,000UNITS/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | 2024-12-27 | |
| 002 | Opdivo Qvantig | nivolumab and hyaluronidase-nvhy | 351(a) | 300MG/2.5ML;5,000UNITS/2.5ML (120MG/2,000UNITS/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | 2025-11-24 | |
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 |
|---|
| 2025-11-01 | N | 002 | Opdivo Qvantig | 351(a) | Rx | Bristol-Myers Squibb Company |
| 2024-12-01 | N | 001 | Opdivo Qvantig | 351(a) | Rx | Bristol-Myers Squibb Company |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2025-11-01 | 002 | Opdivo Qvantig | 351(a) | Rx | Licensed | 2025-11-24 |
| 2024-12-01 | 001 | Opdivo Qvantig | 351(a) | Rx | Licensed | 2024-12-27 |