Purple Book product · Reference 351(a)
tecelra
afamitresgene autoleucel
At a glance
Aug 01, 2024
Approved
Reference 351(a)
License type
Rx
Marketing
No
Patents listed
Key dates
First licensure
Date the BLA was first licensed.
Aug 01, 2024
1 yr 10 mo ago
Approval
Approval date of this BLA submission.
Aug 01, 2024
1 yr 10 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Aug 01, 2031
in 5 yr 3 mo
Reference product exclusivity ends
12-year reference-product exclusivity window per BPCIA §351(k)(7).
Aug 01, 2036
in 10 yr 4 mo
Pharmaceutical detail
Strength
2.68 x 10^9 to 10 x 10^9 CELL/ML
Dosage form
Suspension
Route
Intravenous
Presentation
Bag
Center
CBER
License number
2416
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
12 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
source kind
Monthly Download
sourceKind · monthly_download
patent status
No Patent List Provided
patentListProvided · No patent list
- 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
