Ranluspec Purple Book BLA 761480
- BLA number
- 761480
- Proprietary names
- Ranluspec
- Proper names
- ranibizumab-hkdz
- Applicant
- Lupin Limited (Biotech Division)
- Center
- CDER
- First observed release
- 2026-08-01
- Latest observed release
- 2026-08-01
- Newest archive release
- 2026-08-01
- FDA patent list
- No patents listed in the captured FDA patent list; 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 | Ranluspec | ranibizumab-hkdz | 351(k) Interchangeable | 6MG/ML (0.3MG/0.05ML) | Injection | Intravitreal | Single-Dose Vial | Rx | Licensed | 2026-06-02 | |
| 002 | Ranluspec | ranibizumab-hkdz | 351(k) Interchangeable | 10MG/ML (0.5MG/0.05ML) | Injection | Intravitreal | Single-Dose Vial | Rx | Licensed | 2026-06-02 | |
| 003 | Ranluspec | ranibizumab-hkdz | 351(k) Interchangeable | 6MG/ML (0.3MG/0.05ML) | Injection | Intravitreal | Pre-Filled Syringe | Rx | Licensed | 2026-06-02 | |
| 004 | Ranluspec | ranibizumab-hkdz | 351(k) Interchangeable | 10MG/ML (0.5MG/0.05ML) | Injection | Intravitreal | Pre-Filled Syringe | Rx | Licensed | 2026-06-02 | |
Reference Biological Product#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125156 | Lucentis | ranibizumab | 351(a) | Disc* | 2026-08-01 |
Published Patent List#
No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2026-08-01 | N | 001 | Ranluspec | 351(k) Interchangeable | Rx | Lupin Limited (Biotech Division) |
| 2026-08-01 | N | 002 | Ranluspec | 351(k) Interchangeable | Rx | Lupin Limited (Biotech Division) |
| 2026-08-01 | N | 003 | Ranluspec | 351(k) Interchangeable | Rx | Lupin Limited (Biotech Division) |
| 2026-08-01 | N | 004 | Ranluspec | 351(k) Interchangeable | Rx | Lupin Limited (Biotech Division) |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2026-08-01 | 001 | Ranluspec | 351(k) Interchangeable | Rx | Licensed | 2026-06-02 |
| 2026-08-01 | 002 | Ranluspec | 351(k) Interchangeable | Rx | Licensed | 2026-06-02 |
| 2026-08-01 | 003 | Ranluspec | 351(k) Interchangeable | Rx | Licensed | 2026-06-02 |
| 2026-08-01 | 004 | Ranluspec | 351(k) Interchangeable | Rx | Licensed | 2026-06-02 |