Purple Book product · Reference 351(a)
Neupogen
filgrastim
Feb 20, 1991
Approved
Reference 351(a)
License type
Rx
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Feb 20, 1991
35 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Mar 30, 2022
4 yr 4 mo ago
Today
Pharmaceutical detail
Strength
480MCG/1.6ML
Dosage form
Injection
Route
Intravenous, Subcutaneous
Presentation
Single-Dose Vial
Center
CDER
License number
1080
Product number
002
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. Its approved biosimilars and interchangeables are listed below.
- 2015ZarxioBiosimilar 351(k)
filgrastim-sndz · Sandoz Inc.
- 2018NivestymBiosimilar 351(k)
filgrastim-aafi · Hospira Inc., a Pfizer Company
- 2022ReleukoBiosimilar 351(k)
filgrastim-ayow · Kashiv BioSciences, LLC
- 2024NypoziBiosimilar 351(k)
filgrastim-txid · Tanvex BioPharma USA, Inc.
- 2026FilkriBiosimilar 351(k)
filgrastim-laha · Accord BioPharma Inc.
3 additional BLA records for this product (other strengths or presentations) are in the same reference family.
Patent list
No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.
Source provenance
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
Does Neupogen have approved biosimilars?
Yes. 5 approved follow-on biologics reference Neupogen in the Purple Book: Zarxio, Nivestym, Releuko, Nypozi, and Filkri.
What is Neupogen's BLA number?
Neupogen is licensed under BLA 103353, held by Amgen Inc..
When was Neupogen approved by the FDA?
Neupogen was approved by the FDA on Feb 20, 1991.
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.
