Purple Book product · Interchangeable
Byooviz
ranibizumab-nuna
At a glance
Sep 17, 2021
Approved
Interchangeable
License type
Rx
Marketing
No
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Sep 17, 2021
4 yr 9 mo ago
Today
Pharmaceutical detail
Strength
10MG/ML
Dosage form
Injection
Route
Intravitreal
Presentation
Single-Dose Vial
Center
CDER
License number
2046
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar of ranibizumab (Lucentis)
Patent list (11)
| Patent | Expires | In | Source |
|---|---|---|---|
| 6,716,602 | Nov 01, 2021 | 4 yr 8 mo ago | FDA |
| 6,828,121 | Jul 08, 2022 | 4 yr ago | FDA |
| 9,688,775 | Dec 31, 2022 | 3 yr 6 mo ago | FDA |
| 6,921,659 | Oct 17, 2023 | 2 yr 8 mo ago | FDA |
| 8,383,773 | Dec 13, 2023 | 2 yr 6 mo ago | FDA |
| 8,574,869 | Jul 08, 2028 | in 2 yr 2 mo | FDA |
| 10,421,984 | Sep 19, 2033 | in 7 yr 5 mo | FDA |
| 9,765,379 | Mar 10, 2034 | in 7 yr 11 mo | FDA |
| 10,017,732 | Mar 14, 2034 | in 7 yr 11 mo | FDA |
| 10,829,732 | Mar 14, 2034 | in 7 yr 11 mo | FDA |
| 10,112,994 | Nov 05, 2035 | in 9 yr 7 mo | FDA |
Taxonomy and ontology
10 termscenter
Center for Drug Evaluation and Research
center · CDER
application pathway
Biologics License Application
blaNumber · BLA
license type
351(k) Interchangeable
blaType · 351(k) Interchangeable
application pathway
Section 351(k) Biosimilar or Interchangeable
blaType · 351(k)
product role
Interchangeable Biologic
blaType · Interchangeable
marketing status
Prescription
marketingStatus · Rx
licensure status
Licensed
licensure · Licensed
dosage form
Injection
dosageForm · Injection
source kind
Monthly Download
sourceKind · monthly_download
patent status
No Patent List Provided
patentListProvided · No patent list
- 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(k) Biosimilar or Interchangeablemaps to351(k) Biosimilar
- Section 351(k) Biosimilar or Interchangeablemaps to351(k) Interchangeable
Source provenance
