Tresiba Purple Book BLA 203314
- BLA number
- 203314
- Proprietary names
- Tresiba
- Proper names
- insulin degludec
- Applicant
- Novo Nordisk Inc.
- 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 | Tresiba | insulin degludec | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2015-09-25 | |
| 002 | Tresiba | insulin degludec | 351(a) | 600UNITS/3ML (200UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2015-09-25 | |
| 003 | Tresiba | insulin degludec | 351(a) | 1,000UNITS/10ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | 2018-11-21 | |
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 |
|---|
| 2020-05-01 | R | 001 | Tresiba | 351(a) | Rx | Novo Nordisk Inc. |
| 2020-05-01 | R | 002 | Tresiba | 351(a) | Rx | Novo Nordisk Inc. |
| 2020-05-01 | R | 003 | Tresiba | 351(a) | Rx | Novo Nordisk Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-05-01 | 001 | Tresiba | 351(a) | Rx | Licensed | 2015-09-25 |
| 2020-05-01 | 002 | Tresiba | 351(a) | Rx | Licensed | 2015-09-25 |
| 2020-05-01 | 003 | Tresiba | 351(a) | Rx | Licensed | 2018-11-21 |