Purple Book product · Reference 351(a)
Rebyota
fecal microbiota, live-jslm
At a glance
Nov 30, 2022
Approved
Reference 351(a)
License type
Rx
Marketing
No
Patents listed
Key dates
First licensure
Date the BLA was first licensed.
Nov 30, 2022
3 yr 7 mo ago
Approval
Approval date of this BLA submission.
Nov 30, 2022
3 yr 7 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Nov 30, 2029
in 3 yr 7 mo
Reference product exclusivity ends
12-year reference-product exclusivity window per BPCIA §351(k)(7).
Nov 30, 2034
in 8 yr 7 mo
Pharmaceutical detail
Strength
BETWEEN 1X10^8 AND 5X10^10CFU
Dosage form
Suspension
Route
Rectal
Presentation
Single-Use Bottle
Center
CBER
License number
2112
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
11 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
source kind
Monthly Download
sourceKind · monthly_download
patent status
No Patent List Provided
patentListProvided · No patent list
exclusivity type
Reference Product Exclusivity
referenceProductExclusivityExpirationDate · Reference Product Exclusivity
- 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
