Neulasta Purple Book BLA 125031
- BLA number
- 125031
- Proprietary names
- Neulasta, Neulasta Onpro
- Proper names
- pegfilgrastim
- Applicant
- Amgen Inc.
- Center
- CDER
- First observed release
- 2020-02-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- FDA patent list
- 1 patents listed; 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 | Neulasta | pegfilgrastim | 351(a) | 6MG/0.6ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2002-01-31 | YES |
| 002 | Neulasta Onpro | pegfilgrastim | 351(a) | 6MG/0.6ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2014-12-23 | |
Biosimilar And Interchangeable Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761039 | Udenyca | pegfilgrastim-cbqv | 351(k) Biosimilar | Rx | 2026-06-01 |
| 761045 | Ziextenzo | pegfilgrastim-bmez | 351(k) Biosimilar | Rx | 2026-06-01 |
| 761075 | Fulphila | pegfilgrastim-jmdb | 351(k) Biosimilar | Rx | 2026-06-01 |
| 761084 | Fylnetra | pegfilgrastim-pbbk | 351(k) Biosimilar | Rx | 2026-06-01 |
| 761111 | Nyvepria | pegfilgrastim-apgf | 351(k) Biosimilar | Rx | 2026-06-01 |
| 761147 | Ennumo | pegfilgrastim-pccg | 351(k) Biosimilar | Rx | 2026-06-01 |
| 761173 | Stimufend | pegfilgrastim-fpgk | 351(k) Biosimilar | Rx | 2026-06-01 |
| 761212 | Armlupeg | pegfilgrastim-unne | 351(k) Biosimilar | Rx | 2026-06-01 |
Published Patent List#
Patent, Expiration, Source updated table| Patent | Expiration | Source updated |
|---|
| 9,856,287 | 2030-06-21 | 2025-06-11 |
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2021-12-01 | U | 001 | Neulasta | 351(a) | Rx | Amgen, Inc. |
| 2020-10-01 | U | 001 | Neulasta | 351(a) | Rx | Amgen, Inc. |
| 2020-10-01 | U | 002 | Neulasta Onpro | 351(a) | Rx | Amgen, Inc. |
| 2020-08-01 | U | 001 | Neulasta | 351(a) | Rx | Amgen Inc. |
| 2020-08-01 | U | 002 | Neulasta Onpro | 351(a) | Rx | Amgen Inc. |
| 2020-05-01 | U | 002 | Neulasta Onpro | 351(a) | Rx | Amgen Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-05-01 | 001 | Neulasta | 351(a) | Rx | Licensed | 2002-01-31 |
| 2020-05-01 | 002 | Neulasta Onpro | 351(a) | Rx | Licensed | 2014-12-23 |
| 2020-02-01 | 001 | Neulasta | 351(a) | Marketed | Licensed | 2002-01-31 |
| 2020-02-01 | 002 | Neulasta | 351(a) | Marketed | Licensed | 2014-12-23 |