Trulicity Purple Book BLA 125469
- BLA number
- 125469
- Proprietary names
- Trulicity
- Proper names
- dulaglutide
- Applicant
- Eli Lilly and Company
- Center
- CDER
- First observed release
- 2020-05-01
- 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 | Trulicity | dulaglutide | 351(a) | 0.75MG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2014-09-18 | |
| 002 | Trulicity | dulaglutide | 351(a) | 1.5MG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2014-09-18 | |
| 003 | Trulicity | dulaglutide | 351(a) | 0.75MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | 2014-09-18 | |
| 004 | Trulicity | dulaglutide | 351(a) | 1.5MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | 2014-09-18 | |
| 005 | Trulicity | dulaglutide | 351(a) | 3MG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2020-09-04 | |
| 006 | Trulicity | dulaglutide | 351(a) | 4.5MG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2020-09-04 | |
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 |
|---|
| 2020-09-01 | N | 005 | Trulicity | 351(a) | Rx | Eli Lilly and Company |
| 2020-09-01 | N | 006 | Trulicity | 351(a) | Rx | Eli Lilly and Company |
| 2020-05-01 | R | 001 | Trulicity | 351(a) | Rx | Eli Lilly and Company |
| 2020-05-01 | R | 002 | Trulicity | 351(a) | Rx | Eli Lilly and Company |
| 2020-05-01 | R | 003 | Trulicity | 351(a) | Disc | Eli Lilly and Company |
| 2020-05-01 | R | 004 | Trulicity | 351(a) | Disc | Eli Lilly and Company |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-09-01 | 005 | Trulicity | 351(a) | Rx | Licensed | 2020-09-04 |
| 2020-09-01 | 006 | Trulicity | 351(a) | Rx | Licensed | 2020-09-04 |
| 2020-05-01 | 001 | Trulicity | 351(a) | Rx | Licensed | 2014-09-18 |
| 2020-05-01 | 002 | Trulicity | 351(a) | Rx | Licensed | 2014-09-18 |
| 2020-05-01 | 003 | Trulicity | 351(a) | Disc | Licensed | 2014-09-18 |
| 2020-05-01 | 004 | Trulicity | 351(a) | Disc | Licensed | 2014-09-18 |