Filgrastim
As of the edition of 20 October 2026, Filgrastim is a protein: marketed, first approved in 1991 (US); acts on CSF3R; US protection ended in 2022.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Protein
- Brand name
- Neupogen
- First approved
- 20 February 1991 (US)
- Approvals on record
- 26 in 7 regions
- Holder of the most recent approval
- Kyowa Kirin; 9 holders in all
- Withdrawn from market
- 13 January 2025 (in some regions)
- Registered trials
- 997, 171 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Heart and blood vessels; Infections; Urinary and reproductive
US protection
US protection ended in 2022.
The orphan exclusivity ended in 2022 (it covers one use only).
UAB Teva Baltics holds a later exclusivity on its own new formulation or combination product, which ended in 2024; it does not protect the original drug.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Filgrastim.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| CSF3R | Granulocyte colony-stimulating factor receptor | Q99062 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 55 | 30 | 2 | 14 |
| Phase 1 | 185 | 117 | 14 | 41 |
| Phase 2 | 594 | 406 | 61 | 92 |
| Phase 3 | 147 | 95 | 13 | 21 |
| Phase 4 | 16 | 6 | 3 | 3 |
| All trials | 997 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Amgen | Applicant and Lead sponsor of trials | 1991 to now |
| Blau Farmaceutica | Applicant | 2005 to now |
| Pfizer | Applicant and Lead sponsor of trials | 2007 to now |
| Eurofarma Laboratorios | Later holder and Lead sponsor of trials | 2011 to now |
| Aché Laboratórios Farmacêuticos | Later holder | 2018 to now |
| Kyowa Kirin | Applicant | 2021 to now |
| UAB Teva Baltics | Acquired holder | 2023 to now |