Sogroya Purple Book BLA 761156
- BLA number
- 761156
- Proprietary names
- Sogroya
- Proper names
- somapacitan-beco
- Applicant
- Novo Nordisk Inc.
- Center
- CDER
- First observed release
- 2020-08-01
- 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 | Sogroya | somapacitan-beco | 351(a) | 10MG/1.5ML (6.7MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2020-08-28 | |
| 002 | Sogroya | somapacitan-beco | 351(a) | 5MG/1.5ML (3.3MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2021-10-01 | |
| 003 | Sogroya | somapacitan-beco | 351(a) | 15MG/1.5ML (10MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2023-04-28 | |
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 |
|---|
| 2023-05-01 | N | 003 | Sogroya | 351(a) | Rx | Novo Nordisk Inc. |
| 2021-09-01 | N | 002 | Sogroya | 351(a) | Rx | Novo Nordisk Inc. |
| 2020-08-01 | N | 001 | Sogroya | 351(a) | Rx | Novo Nordisk Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2023-05-01 | 003 | Sogroya | 351(a) | Rx | Licensed | 2023-04-28 |
| 2021-09-01 | 002 | Sogroya | 351(a) | Rx | Licensed | 2021-10-01 |
| 2020-08-01 | 001 | Sogroya | 351(a) | Rx | Licensed | 2020-08-28 |