filgrastim (Neupogen)
filgrastim is an FDA-licensed reference biologic from Amgen Inc., with 4 approved follow-on biologics. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
4
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
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 10 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
4 yr 3 mo ago
Biosimilars & interchangeables for filgrastim
4 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 |
Frequently asked questions
What biosimilars are approved for filgrastim (Neupogen)?
The FDA Purple Book lists 4 approved follow-on biologics referencing filgrastim: Zarxio, Nivestym, Releuko, and Nypozi. Of these, 0 are interchangeable biosimilars and 4 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, and Tanvex BioPharma USA, Inc..
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.