Purple Book product · Reference 351(a)
Helixate Fs, Kogenate, Kogenate Fs
Antihemophilic Factor (Recombinant)
At a glance
Jun 07, 2007
Approved
Reference 351(a)
License type
Disc
Marketing
No
Patents listed
Key dates
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Feb 25, 2000
26 yr 8 mo ago
Approval
Approval date of this BLA submission.
Jun 07, 2007
19 yr 3 mo ago
Today
Pharmaceutical detail
Strength
2000IU
Dosage form
For Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CBER
License number
0008
Product number
004
Submission type
Supplement
Supplement number
5672
Change type
U
Reference product family
View full familyThis is the reference (originator) product. Biosimilars and interchangeables referencing it are listed below.
- 2002Helixate Fs, Kogenate, Kogenate FsReference 351(a)
Antihemophilic Factor (Recombinant) · Bayer HealthCare LLC
- 2002Helixate Fs, Kogenate, Kogenate FsReference 351(a)
Antihemophilic Factor (Recombinant) · Bayer HealthCare LLC
- 2002Helixate Fs, Kogenate, Kogenate FsReference 351(a)
Antihemophilic Factor (Recombinant) · Bayer HealthCare LLC
- 2009Helixate Fs, Kogenate, Kogenate FsReference 351(a)
Antihemophilic Factor (Recombinant) · Bayer HealthCare LLC
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
13 termscenter
Center for Biologics Evaluation and Research
center · CBER
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
Discontinued
marketingStatus · Disc
licensure status
Voluntarily Revoked
licensure · Voluntarily Revoked
route
Intravenous
routeOfAdministration · Intravenous
dosage form
For Injection
dosageForm · For Injection
source kind
Monthly Download
sourceKind · monthly_download
- Food and Drug Administrationparent ofCenter for Biologics 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
