Purple Book product · Reference 351(a)
Xolair
omalizumab
At a glance
Aug 17, 2023
Approved
Reference 351(a)
License type
Rx
Marketing
Yes
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Aug 17, 2023
2 yr 10 mo ago
Today
Pharmaceutical detail
Strength
300MG/2ML
Dosage form
Injection
Route
Subcutaneous
Presentation
Autoinjector
Center
CDER
License number
1048
Product number
007
Submission type
Supplement
Supplement number
5242
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. Biosimilars and interchangeables referencing it are listed below.
- 2003XolairReference 351(a)
omalizumab · Genentech, Inc.
- 2018XolairReference 351(a)
omalizumab · Genentech, Inc.
- 2018XolairReference 351(a)
omalizumab · Genentech, Inc.
- 2023XolairReference 351(a)
omalizumab · Genentech, Inc.
- 2023XolairReference 351(a)
omalizumab · Genentech, Inc.
- 2023XolairReference 351(a)
omalizumab · Genentech, Inc.
- 2025OmlycloInterchangeable
omalizumab-igec · CELLTRION, Inc.
- 2025OmlycloInterchangeable
omalizumab-igec · CELLTRION, Inc.
- 2025OmlycloInterchangeable
omalizumab-igec · CELLTRION, Inc.
Patent list (8)
| Patent | Expires | In | Source |
|---|---|---|---|
| 10,034,940 | Nov 04, 2025 | 7 mo ago | FDA |
| 11,078,294 | Jul 08, 2028 | in 2 yr 2 mo | FDA |
| 11,987,637 | Jul 08, 2028 | in 2 yr 2 mo | FDA |
| 8,574,869 | Jul 08, 2028 | in 2 yr 2 mo | FDA |
| 10,017,732 | Mar 14, 2034 | in 7 yr 11 mo | FDA |
| 10,676,710 | Mar 14, 2034 | in 7 yr 11 mo | FDA |
| 10,829,732 | Mar 14, 2034 | in 7 yr 11 mo | FDA |
| 12,030,959 | Jul 20, 2043 | in 17 yr 5 mo | FDA |
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
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
