pegfilgrastim (Neulasta)
pegfilgrastim is an FDA-licensed reference biologic from Amgen Inc., with 7 approved follow-on biologics. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
7
Biosimilars
0
Interchangeables
1
Listed patents
2002
Reference approved
Reference product
Neulasta pegfilgrastim
Amgen Inc.
- Approved
- Jan 31, 2002
- Marketing
- Rx
- Center
- CDER
- Patents
- 1 listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for pegfilgrastim, in chronological order.
Reference approval
Approval date of the reference pegfilgrastim product.
24 yr 8 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
3 yr 7 mo ago
Patent 9,856,287 expires
Published Purple Book patent expiration.
in 4 yr 1 mo
Biosimilars & interchangeables for pegfilgrastim
7 FDA-licensed follow-on biologics referencing pegfilgrastim.
| Product | Proper name | Applicant | Type | BLA | Approved |
|---|---|---|---|---|---|
| Fulphila | pegfilgrastim-jmdb | Biocon Biologics Inc. | Biosimilar 351(k) | 761075 | Jun 04, 2018 |
| Udenyca | pegfilgrastim-cbqv | Accord BioPharma Inc. | Biosimilar 351(k) | 761039 | Nov 02, 2018 |
| Ziextenzo | pegfilgrastim-bmez | Sandoz Inc. | Biosimilar 351(k) | 761045 | Nov 04, 2019 |
| Nyvepria | pegfilgrastim-apgf | Hospira Inc., a Pfizer Company | Biosimilar 351(k) | 761111 | Jun 10, 2020 |
| Fylnetra | pegfilgrastim-pbbk | Kashiv BioSciences, LLC | Biosimilar 351(k) | 761084 | May 26, 2022 |
| Stimufend | pegfilgrastim-fpgk | Fresenius Kabi USA, LLC | Biosimilar 351(k) | 761173 | Sep 01, 2022 |
| Armlupeg | pegfilgrastim-unne | Lupin Limited (Biotech Division) | Biosimilar 351(k) | 761212 | Nov 28, 2025 |
Published patents
Patents the BLA holder has published in the FDA Purple Book Patent List for pegfilgrastim.
| Patent | Expires | In |
|---|---|---|
| 9,856,287 | Jun 21, 2030 | in 4 yr 1 mo |
Frequently asked questions
What biosimilars are approved for pegfilgrastim (Neulasta)?
The FDA Purple Book lists 7 approved follow-on biologics referencing pegfilgrastim: Fulphila, Udenyca, Ziextenzo, Nyvepria, Fylnetra, Stimufend, and Armlupeg. Of these, 0 are interchangeable biosimilars and 7 are 351(k) biosimilars.
Who makes pegfilgrastim biosimilars?
Companies with FDA-approved follow-on biologics referencing pegfilgrastim include Biocon Biologics Inc., Accord BioPharma Inc., Sandoz Inc., Hospira Inc., a Pfizer Company, Kashiv BioSciences, LLC, Fresenius Kabi USA, LLC, and Lupin Limited (Biotech Division).
How many patents are listed for pegfilgrastim (Neulasta) in the Purple Book?
1 patent is published in the FDA Purple Book Patent List for pegfilgrastim.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.