Purple Book product · Reference 351(a)
Neulasta
pegfilgrastim
At a glance
Jan 31, 2002
Approved
Reference 351(a)
License type
Rx
Marketing
Yes
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Jan 31, 2002
24 yr 8 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Nov 13, 2022
3 yr 7 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. Biosimilars and interchangeables referencing it are listed below.
- 2014Neulasta OnproReference 351(a)
pegfilgrastim · Amgen Inc.
- 2020NyvepriaBiosimilar 351(k)
pegfilgrastim-apgf · Hospira Inc., a Pfizer Company
- 2019ZiextenzoBiosimilar 351(k)
pegfilgrastim-bmez · Sandoz Inc.
- 2018UdenycaBiosimilar 351(k)
pegfilgrastim-cbqv · Accord BioPharma Inc.
- 2023UdenycaBiosimilar 351(k)
pegfilgrastim-cbqv · Accord BioPharma Inc.
- 2023Udenyca OnbodyBiosimilar 351(k)
pegfilgrastim-cbqv · Accord BioPharma Inc.
- 2022StimufendBiosimilar 351(k)
pegfilgrastim-fpgk · Fresenius Kabi USA, LLC
- 2018FulphilaBiosimilar 351(k)
pegfilgrastim-jmdb · Biocon Biologics Inc.
- 2022FylnetraBiosimilar 351(k)
pegfilgrastim-pbbk · Kashiv BioSciences, LLC
- 2025ArmlupegBiosimilar 351(k)
pegfilgrastim-unne · Lupin Limited (Biotech Division)
Patent list (1)
| Patent | Expires | In | Source |
|---|---|---|---|
| 9,856,287 | Jun 21, 2030 | in 4 yr 1 mo | FDA |
Taxonomy and ontology
12 termscenter
Center for Drug Evaluation and Research
center · CDER
application pathway
Biologics License Application
blaNumber · BLA
license type
351(a)
blaType · 351(a)
application pathway
Section 351(a) Biologic
blaType · 351(a)
product role
Reference or Standalone Biologic
blaType · Reference product
marketing status
Prescription
marketingStatus · Rx
licensure status
Licensed
licensure · Licensed
route
Subcutaneous
routeOfAdministration · Subcutaneous
dosage form
Injection
dosageForm · Injection
source kind
Monthly Download
sourceKind · monthly_download
- Food and Drug Administrationparent ofCenter for Drug Evaluation and Research
- Food and Drug Administrationsource forMonthly Download
- Biologics License Applicationparent ofSection 351(a) Biologic
- Biologics License Applicationparent ofSection 351(k) Biosimilar or Interchangeable
- Section 351(a) Biologicmaps to351(a)
- 351(a)classifiesReference or Standalone Biologic
Source provenance
