Purple Book product · Reference 351(a)
Zolgensma
onasemnogene abeparvovec-xioi
At a glance
May 24, 2019
Approved
Reference 351(a)
License type
Rx
Marketing
No
Patents listed
Key dates
First licensure
Date the BLA was first licensed.
May 24, 2019
7 yr 2 mo ago
Approval
Approval date of this BLA submission.
May 24, 2019
7 yr 2 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Nov 24, 2026
in 6 mo
Reference product exclusivity ends
12-year reference-product exclusivity window per BPCIA §351(k)(7).
Nov 24, 2031
in 5 yr 7 mo
Pharmaceutical detail
Strength
2x10^13VG/ML
Dosage form
Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CBER
License number
2250
Product number
001
Submission type
Original
Supplement number
0
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. Biosimilars and interchangeables referencing it are listed below.
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
Prescription
marketingStatus · Rx
licensure status
Licensed
licensure · Licensed
route
Intravenous
routeOfAdministration · Intravenous
dosage form
Injection
dosageForm · 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
