Purple Book product · Reference 351(a)
Neulasta
pegfilgrastim
Jan 31, 2002
Approved
Reference 351(a)
License type
Rx
Marketing
1
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Jan 31, 2002
24 yr 10 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Nov 13, 2022
3 yr 9 mo ago
Today
Pharmaceutical detail
Strength
6MG/0.6ML
Dosage form
Injection
Route
Subcutaneous
Presentation
Pre-Filled Syringe
Center
CDER
License number
1080
Product number
001
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.
- 2014Neulasta OnproReference 351(a)
pegfilgrastim · Amgen Inc.
- 2018FulphilaBiosimilar 351(k)
pegfilgrastim-jmdb · Biocon Biologics Inc.
- 2018UdenycaBiosimilar 351(k)
pegfilgrastim-cbqv · Accord BioPharma Inc.
- 2019ZiextenzoBiosimilar 351(k)
pegfilgrastim-bmez · Sandoz Inc.
- 2020NyvepriaBiosimilar 351(k)
pegfilgrastim-apgf · Hospira Inc., a Pfizer Company
- 2022FylnetraBiosimilar 351(k)
pegfilgrastim-pbbk · Kashiv BioSciences, LLC
- 2022StimufendBiosimilar 351(k)
pegfilgrastim-fpgk · Fresenius Kabi USA, LLC
- 2023Udenyca OnbodyBiosimilar 351(k)
pegfilgrastim-cbqv · Accord BioPharma Inc.
- 2025ArmlupegBiosimilar 351(k)
pegfilgrastim-unne · Lupin Limited (Biotech Division)
- 2026EnnumoBiosimilar 351(k)
pegfilgrastim-pccg · Accord BioPharma Inc.
Patent list (1)
| Patent | Expires | In | Source |
|---|---|---|---|
| 9,856,287 | Jun 21, 2030 | in 4 yr | FDA |
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
When do Neulasta's patents expire?
The FDA Purple Book lists 1 published patent for Neulasta, with the last listed patent expiring Jun 21, 2030. Every patent below links to its FDA source record so you can verify the expiration date.
Does Neulasta have approved biosimilars?
Yes. 10 approved follow-on biologics reference Neulasta in the Purple Book: Neulasta Onpro, Fulphila, Udenyca, Ziextenzo, Nyvepria, Fylnetra, Stimufend, Udenyca Onbody, Armlupeg, and Ennumo.
What is Neulasta's BLA number?
Neulasta is licensed under BLA 125031, held by Amgen Inc..
When was Neulasta approved by the FDA?
Neulasta was approved by the FDA on Jan 31, 2002.
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.
