Niktimvo Purple Book BLA 761411
- BLA number
- 761411
- Proprietary names
- Niktimvo
- Proper names
- axatilimab-csfr
- Applicant
- Incyte Corporation
- Center
- CDER
- First observed release
- 2024-08-01
- Latest observed release
- 2026-07-01
- Newest archive release
- 2026-07-01
- 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 | Niktimvo | axatilimab-csfr | 351(a) | 50MG/ML | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | 2024-08-14 | |
| 002 | Niktimvo | axatilimab-csfr | 351(a) | 9MG/0.18ML (50MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2025-01-14 | |
| 003 | Niktimvo | axatilimab-csfr | 351(a) | 22MG/0.44ML (50MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2025-01-14 | |
| 004 | Niktimvo | axatilimab-csfr | 351(a) | 9MG/0.9ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2026-06-24 | |
| 005 | Niktimvo | axatilimab-csfr | 351(a) | 22MG/2.2ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2026-06-24 | |
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 |
|---|
| 2026-07-01 | U | 001 | Niktimvo | 351(a) | Disc | Incyte Corporation |
| 2026-07-01 | N | 002 | Niktimvo | 351(a) | Rx | Incyte Corporation |
| 2026-07-01 | N | 003 | Niktimvo | 351(a) | Rx | Incyte Corporation |
| 2026-07-01 | N | 004 | Niktimvo | 351(a) | Rx | Incyte Corporation |
| 2026-07-01 | N | 005 | Niktimvo | 351(a) | Rx | Incyte Corporation |
| 2024-11-01 | U | 001 | Niktimvo | 351(a) | Rx | Incyte Corporation |
| 2024-08-01 | N | 001 | Niktimvo | 351(a) | Rx | Incyte Corporation |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2026-07-01 | 001 | Niktimvo | 351(a) | Disc | Licensed | 2024-08-14 |
| 2026-07-01 | 002 | Niktimvo | 351(a) | Rx | Licensed | 2025-01-14 |
| 2026-07-01 | 003 | Niktimvo | 351(a) | Rx | Licensed | 2025-01-14 |
| 2026-07-01 | 004 | Niktimvo | 351(a) | Rx | Licensed | 2026-06-24 |
| 2026-07-01 | 005 | Niktimvo | 351(a) | Rx | Licensed | 2026-06-24 |
| 2024-08-01 | 001 | Niktimvo | 351(a) | Rx | Licensed | 2024-08-14 |