Purple Book product · Reference 351(a)
Lucentis
ranibizumab
At a glance
Oct 13, 2016
Approved
Reference 351(a)
License type
Rx
Marketing
Yes
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Oct 13, 2016
9 yr 9 mo ago
Today
Pharmaceutical detail
Strength
10MG/ML (0.5MG/0.05ML)
Dosage form
Injection
Route
Intravitreal
Presentation
Pre-Filled Syringe
Center
CDER
License number
1048
Product number
003
Submission type
Supplement
Supplement number
110
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. Biosimilars and interchangeables referencing it are listed below.
- 2006LucentisReference 351(a)
ranibizumab · Genentech, Inc.
- 2012LucentisReference 351(a)
ranibizumab · Genentech, Inc.
- 2018LucentisReference 351(a)
ranibizumab · Genentech, Inc.
- 2022CimerliInterchangeable
ranibizumab-eqrn · Sandoz Inc.
- 2022CimerliInterchangeable
ranibizumab-eqrn · Sandoz Inc.
- 2025NufymcoInterchangeable
ranibizumab-leyk · Formycon AG
- 2025NufymcoInterchangeable
ranibizumab-leyk · Formycon AG
- 2021ByoovizInterchangeable
ranibizumab-nuna · Samsung Bioepis Co., Ltd.
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(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
dosage form
Injection
dosageForm · Injection
source kind
Monthly Download
sourceKind · monthly_download
patent status
Patent List Provided
patentListProvided · Patent listed
- 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
