Purple Book product · Reference 351(a)
Neupogen
filgrastim
At a glance
Feb 20, 1991
Approved
Reference 351(a)
License type
Rx
Marketing
No
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Feb 20, 1991
35 yr 10 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Mar 30, 2022
4 yr 3 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. Biosimilars and interchangeables referencing it are listed below.
- 1991NeupogenReference 351(a)
filgrastim · Amgen Inc.
- 2000NeupogenReference 351(a)
filgrastim · Amgen Inc.
- 2000NeupogenReference 351(a)
filgrastim · Amgen Inc.
- 2018NivestymBiosimilar 351(k)
filgrastim-aafi · Hospira Inc., a Pfizer Company
- 2018NivestymBiosimilar 351(k)
filgrastim-aafi · Hospira Inc., a Pfizer Company
- 2018NivestymBiosimilar 351(k)
filgrastim-aafi · Hospira Inc., a Pfizer Company
- 2018NivestymBiosimilar 351(k)
filgrastim-aafi · Hospira Inc., a Pfizer Company
- 2022ReleukoBiosimilar 351(k)
filgrastim-ayow · Kashiv BioSciences, LLC
- 2022ReleukoBiosimilar 351(k)
filgrastim-ayow · Kashiv BioSciences, LLC
- 2022ReleukoBiosimilar 351(k)
filgrastim-ayow · Kashiv BioSciences, LLC
- 2022ReleukoBiosimilar 351(k)
filgrastim-ayow · Kashiv BioSciences, LLC
- 2015ZarxioBiosimilar 351(k)
filgrastim-sndz · Sandoz Inc.
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.
Taxonomy and ontology
11 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
dosage form
Injection
dosageForm · Injection
source kind
Monthly Download
sourceKind · monthly_download
patent status
No Patent List Provided
patentListProvided · No patent list
- 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
