filgrastim (Neupogen)
filgrastim is an FDA-licensed reference biologic from Amgen Inc., with 5 approved follow-on biologics. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
5
Biosimilars
0
Interchangeables
0
Listed patents
1991
Reference approved
Reference product
Neupogen filgrastim
Amgen Inc.
- Approved
- Feb 20, 1991
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for filgrastim from the RCSB Protein Data Bank (PDB 1RHG).
Interactive biological assembly from PDB entry 1RHG. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for filgrastim, in chronological order.
Reference approval
Approval date of the reference filgrastim product.
35 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
4 yr 4 mo ago
Biosimilars & interchangeables for filgrastim
5 FDA-licensed follow-on biologics referencing filgrastim.
| Product | Proper name | Applicant | Type | BLA | Approved |
|---|---|---|---|---|---|
| Zarxio | filgrastim-sndz | Sandoz Inc. | Biosimilar 351(k) | 125553 | Mar 06, 2015 |
| Nivestym | filgrastim-aafi | Hospira Inc., a Pfizer Company | Biosimilar 351(k) | 761080 | Jul 20, 2018 |
| Releuko | filgrastim-ayow | Kashiv BioSciences, LLC | Biosimilar 351(k) | 761082 | Feb 25, 2022 |
| Nypozi | filgrastim-txid | Tanvex BioPharma USA, Inc. | Biosimilar 351(k) | 761126 | Jun 28, 2024 |
| Filkri | filgrastim-laha | Accord BioPharma Inc. | Biosimilar 351(k) | 761027 | Jan 15, 2026 |
Frequently asked questions
What biosimilars are approved for filgrastim (Neupogen)?
The FDA Purple Book lists 5 approved follow-on biologics referencing filgrastim: Zarxio, Nivestym, Releuko, Nypozi, and Filkri. Of these, 0 are interchangeable biosimilars and 5 are 351(k) biosimilars.
Who makes filgrastim biosimilars?
Companies with FDA-approved follow-on biologics referencing filgrastim include Sandoz Inc., Hospira Inc., a Pfizer Company, Kashiv BioSciences, LLC, Tanvex BioPharma USA, Inc., and Accord BioPharma Inc..
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.