Lucentis Purple Book BLA 125156
- BLA number
- 125156
- Proprietary names
- Lucentis
- Proper names
- ranibizumab
- Applicant
- Genentech, Inc.
- Center
- CDER
- First observed release
- 2020-05-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- FDA patent list
- 11 patents listed; source updated 2025-06-11
- Coverage
- Present in newest release
Latest Known Product Presentations#
Product, Proprietary name, Proper name table| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | Lucentis | ranibizumab | 351(a) | 10MG/ML (0.5MG/0.05ML) | Injection | Intravitreal | Single-Dose Vial | Disc* | Licensed | 2006-06-30 | YES |
| 002 | Lucentis | ranibizumab | 351(a) | 6MG/ML (0.3MG/0.05ML) | Injection | Intravitreal | Single-Dose Vial | Disc* | Licensed | 2012-08-10 | YES |
| 003 | Lucentis | ranibizumab | 351(a) | 10MG/ML (0.5MG/0.05ML) | Injection | Intravitreal | Pre-Filled Syringe | Rx | Licensed | 2016-10-13 | YES |
| 004 | Lucentis | ranibizumab | 351(a) | 6MG/ML (0.3MG/0.05ML) | Injection | Intravitreal | Pre-Filled Syringe | Rx | Licensed | 2018-03-20 | YES |
Biosimilar And Interchangeable Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761165 | Cimerli | ranibizumab-eqrn | 351(k) Interchangeable | Rx | 2026-06-01 |
| 761202 | Byooviz | ranibizumab-nuna | 351(k) Interchangeable | Rx | 2026-06-01 |
| 761473 | Nufymco | ranibizumab-leyk | 351(k) Interchangeable | Rx | 2026-06-01 |
Published Patent List#
Patent, Expiration, Source updated table| Patent | Expiration | Source updated |
|---|
| 10,112,994 | 2035-11-05 | 2025-06-11 |
| 10,017,732 | 2034-03-14 | 2025-06-11 |
| 10,829,732 | 2034-03-14 | 2025-06-11 |
| 9,765,379 | 2034-03-10 | 2025-06-11 |
| 10,421,984 | 2033-09-19 | 2025-06-11 |
| 8,574,869 | 2028-07-08 | 2025-06-11 |
| 8,383,773 | 2023-12-13 | 2025-06-11 |
| 6,921,659 | 2023-10-17 | 2025-06-11 |
| 9,688,775 | 2022-12-31 | 2025-06-11 |
| 6,828,121 | 2022-07-08 | 2025-06-11 |
| 6,716,602 | 2021-11-01 | 2025-06-11 |
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2025-09-01 | U | 001 | Lucentis | 351(a) | Disc* | Genentech, Inc. |
| 2025-09-01 | U | 002 | Lucentis | 351(a) | Disc* | Genentech, Inc. |
| 2021-06-01 | U | 004 | Lucentis | 351(a) | Rx | Genentech, Inc. |
| 2021-05-01 | U | 004 | Lucentis | 351(a) | Rx | Genentech, Inc. |
| 2020-05-01 | R | 001 | Lucentis | 351(a) | Rx | Genentech, Inc. |
| 2020-05-01 | R | 002 | Lucentis | 351(a) | Rx | Genentech, Inc. |
| 2020-05-01 | R | 003 | Lucentis | 351(a) | Rx | Genentech, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2025-09-01 | 001 | Lucentis | 351(a) | Disc* | Licensed | 2006-06-30 |
| 2025-09-01 | 002 | Lucentis | 351(a) | Disc* | Licensed | 2012-08-10 |
| 2021-05-01 | 004 | Lucentis | 351(a) | Rx | Licensed | 2018-03-20 |
| 2020-05-01 | 001 | Lucentis | 351(a) | Rx | Licensed | 2006-06-30 |
| 2020-05-01 | 002 | Lucentis | 351(a) | Rx | Licensed | 2012-08-10 |
| 2020-05-01 | 003 | Lucentis | 351(a) | Rx | Licensed | 2016-10-13 |