Purple Book product · Interchangeable
Nufymco
ranibizumab-leyk
At a glance
Dec 18, 2025
Approved
Interchangeable
License type
Rx
Marketing
No
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Dec 18, 2025
6 mo ago
Today
Pharmaceutical detail
Strength
10MG/ML (0.5MG/0.05ML)
Dosage form
Injection
Route
Intravitreal
Presentation
Single-Dose Vial
Center
CDER
License number
2322
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar of ranibizumab (Lucentis)
- 2006LucentisReference 351(a)
ranibizumab · Genentech, Inc.
- 2021SusvimoReference 351(a)
ranibizumab · Genentech, Inc.
- 2012LucentisReference 351(a)
ranibizumab · Genentech, Inc.
- 2016LucentisReference 351(a)
ranibizumab · Genentech, Inc.
- 2018LucentisReference 351(a)
ranibizumab · Genentech, Inc.
- 2025NufymcoInterchangeable
ranibizumab-leyk · Formycon AG
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
