Nivestym Purple Book BLA 761080
- BLA number
- 761080
- Proprietary names
- Nivestym
- Proper names
- filgrastim-aafi
- Applicant
- Hospira Inc., a Pfizer Company
- Center
- CDER
- First observed release
- 2020-02-01
- 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 | Nivestym | filgrastim-aafi | 351(k) Biosimilar | 300MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | 2018-07-20 | |
| 002 | Nivestym | filgrastim-aafi | 351(k) Biosimilar | 480MCG/1.6ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | 2018-07-20 | |
| 003 | Nivestym | filgrastim-aafi | 351(k) Biosimilar | 300MCG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2018-07-20 | |
| 004 | Nivestym | filgrastim-aafi | 351(k) Biosimilar | 480MCG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2018-07-20 | |
Reference Biological Product#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 103353 | Neupogen | filgrastim | 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 |
|---|
| 2023-01-01 | U | 003 | Nivestym | 351(k) Biosimilar | Rx | Hospira Inc., a Pfizer Company |
| 2023-01-01 | U | 004 | Nivestym | 351(k) Biosimilar | Rx | Hospira Inc., a Pfizer Company |
| 2020-10-01 | U | 001 | Nivestym | 351(k) Biosimilar | Rx | Hospira Inc., a Pfizer Company |
| 2020-10-01 | U | 002 | Nivestym | 351(k) Biosimilar | Rx | Hospira Inc., a Pfizer Company |
| 2020-10-01 | U | 003 | Nivestym | 351(k) Biosimilar | Rx | Hospira Inc., a Pfizer Company |
| 2020-10-01 | U | 004 | Nivestym | 351(k) Biosimilar | Rx | Hospira Inc., a Pfizer Company |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-05-01 | 001 | Nivestym | 351(k) Biosimilar | Rx | Licensed | 2018-07-20 |
| 2020-05-01 | 002 | Nivestym | 351(k) Biosimilar | Rx | Licensed | 2018-07-20 |
| 2020-05-01 | 003 | Nivestym | 351(k) Biosimilar | Rx | Licensed | 2018-07-20 |
| 2020-05-01 | 004 | Nivestym | 351(k) Biosimilar | Rx | Licensed | 2018-07-20 |
| 2020-02-01 | 001 | Nivestym | 351(k) Biosimilar | Marketed | Licensed | 2018-07-20 |
| 2020-02-01 | 002 | Nivestym | 351(k) Biosimilar | Marketed | Licensed | 2018-07-20 |
| 2020-02-01 | 003 | Nivestym | 351(k) Biosimilar | Marketed | Licensed | 2018-07-20 |
| 2020-02-01 | 004 | Nivestym | 351(k) Biosimilar | Marketed | Licensed | 2018-07-20 |