Omvoh Purple Book BLA 761279
- BLA number
- 761279
- Proprietary names
- Omvoh
- Proper names
- mirikizumab-mrkz
- Applicant
- Eli Lilly and Company
- Center
- CDER
- First observed release
- 2023-11-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- 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 | Omvoh | mirikizumab-mrkz | 351(a) | 300MG/15ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2023-10-26 | |
| 002 | Omvoh | mirikizumab-mrkz | 351(a) | 100MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2023-10-26 | |
| 003 | Omvoh | mirikizumab-mrkz | 351(a) | 100MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2025-01-15 | |
| 004 | Omvoh | mirikizumab-mrkz | 351(a) | 200MG/2ML (100MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2025-01-15 | |
| 005 | Omvoh | mirikizumab-mrkz | 351(a) | 200MG/2ML (100MG/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2025-01-15 | |
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 |
|---|
| 2025-02-01 | N | 003 | Omvoh | 351(a) | Rx | Eli Lilly and Company |
| 2025-02-01 | N | 004 | Omvoh | 351(a) | Rx | Eli Lilly and Company |
| 2025-02-01 | N | 005 | Omvoh | 351(a) | Rx | Eli Lilly and Company |
| 2025-01-01 | N | 003 | Omvoh | 351(a) | Rx | Eli Lilly and Company |
| 2025-01-01 | N | 004 | Omvoh | 351(a) | Rx | Eli Lilly and Company |
| 2025-01-01 | N | 005 | Omvoh | 351(a) | Rx | Eli Lilly and Company |
| 2023-11-01 | N | 001 | Omvoh | 351(a) | Rx | Eli Lilly and Company |
| 2023-11-01 | N | 002 | Omvoh | 351(a) | Rx | Eli Lilly and Company |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2025-01-01 | 003 | Omvoh | 351(a) | Rx | Licensed | 2025-01-15 |
| 2025-01-01 | 004 | Omvoh | 351(a) | Rx | Licensed | 2025-01-15 |
| 2025-01-01 | 005 | Omvoh | 351(a) | Rx | Licensed | 2025-01-15 |
| 2023-11-01 | 001 | Omvoh | 351(a) | Rx | Licensed | 2023-10-26 |
| 2023-11-01 | 002 | Omvoh | 351(a) | Rx | Licensed | 2023-10-26 |