Lyumjev Purple Book BLA 761109
- BLA number
- 761109
- Proprietary names
- Lyumjev
- Proper names
- insulin lispro-aabc
- Applicant
- Eli Lilly and Company
- Center
- CDER
- First observed release
- 2020-06-01
- 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 | Lyumjev | insulin lispro-aabc | 351(a) | 1,000UNITS/10ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Rx | Licensed | 2020-06-15 | |
| 002 | Lyumjev | insulin lispro-aabc | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Autoinjector | Disc | Licensed | 2020-06-15 | |
| 003 | Lyumjev | insulin lispro-aabc | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Autoinjector | Rx | Licensed | 2020-06-15 | |
| 004 | Lyumjev | insulin lispro-aabc | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Autoinjector | Rx | Licensed | 2020-06-15 | |
| 005 | Lyumjev | insulin lispro-aabc | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Multi-Dose Cartridge | Disc | Licensed | 2020-06-15 | |
| 006 | Lyumjev | insulin lispro-aabc | 351(a) | 600UNITS/3ML (200UNITS/ML) | Injection | Intravenous, Subcutaneous | Autoinjector | Rx | Licensed | 2020-06-15 | |
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 |
|---|
| 2023-07-01 | U | 002 | Lyumjev | 351(a) | Disc | Eli Lilly and Company |
| 2023-07-01 | U | 005 | Lyumjev | 351(a) | Disc | Eli Lilly and Company |
| 2020-06-01 | N | 001 | Lyumjev | 351(a) | Rx | Eli Lilly and Company |
| 2020-06-01 | N | 002 | Lyumjev | 351(a) | Rx | Eli Lilly and Company |
| 2020-06-01 | N | 003 | Lyumjev | 351(a) | Rx | Eli Lilly and Company |
| 2020-06-01 | N | 004 | Lyumjev | 351(a) | Rx | Eli Lilly and Company |
| 2020-06-01 | N | 005 | Lyumjev | 351(a) | Rx | Eli Lilly and Company |
| 2020-06-01 | N | 006 | Lyumjev | 351(a) | Rx | Eli Lilly and Company |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2023-07-01 | 002 | Lyumjev | 351(a) | Disc | Licensed | 2020-06-15 |
| 2023-07-01 | 005 | Lyumjev | 351(a) | Disc | Licensed | 2020-06-15 |
| 2020-06-01 | 001 | Lyumjev | 351(a) | Rx | Licensed | 2020-06-15 |
| 2020-06-01 | 002 | Lyumjev | 351(a) | Rx | Licensed | 2020-06-15 |
| 2020-06-01 | 003 | Lyumjev | 351(a) | Rx | Licensed | 2020-06-15 |
| 2020-06-01 | 004 | Lyumjev | 351(a) | Rx | Licensed | 2020-06-15 |
| 2020-06-01 | 005 | Lyumjev | 351(a) | Rx | Licensed | 2020-06-15 |
| 2020-06-01 | 006 | Lyumjev | 351(a) | Rx | Licensed | 2020-06-15 |