Tremfya Purple Book BLA 761061
- BLA number
- 761061
- Proprietary names
- Tremfya
- Proper names
- guselkumab
- Applicant
- Janssen Biotech, 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 | Tremfya | guselkumab | 351(a) | 100MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2017-07-13 | |
| 002 | Tremfya | guselkumab | 351(a) | 100MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2019-01-28 | |
| 003 | Tremfya | guselkumab | 351(a) | 200MG/2ML (100MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2024-09-11 | |
| 004 | Tremfya | guselkumab | 351(a) | 200MG/2ML (100MG/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2024-09-11 | |
| 005 | Tremfya | guselkumab | 351(a) | 200MG/20ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2024-09-11 | |
| 006 | Tremfya | guselkumab | 351(a) | 100MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2025-03-25 | |
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 |
|---|
| 2025-11-01 | N | 006 | Tremfya | 351(a) | Rx | Janssen Biotech, Inc. |
| 2024-09-01 | U | 002 | Tremfya | 351(a) | Rx | Janssen Biotech, Inc. |
| 2024-09-01 | N | 003 | Tremfya | 351(a) | Rx | Janssen Biotech, Inc. |
| 2024-09-01 | N | 004 | Tremfya | 351(a) | Rx | Janssen Biotech, Inc. |
| 2024-09-01 | N | 005 | Tremfya | 351(a) | Rx | Janssen Biotech, Inc. |
| 2020-05-01 | R | 001 | Tremfya | 351(a) | Rx | Janssen Biotech, Inc. |
| 2020-05-01 | R | 002 | Tremfya | 351(a) | Rx | Janssen Biotech, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2025-11-01 | 006 | Tremfya | 351(a) | Rx | Licensed | 2025-03-25 |
| 2024-09-01 | 002 | Tremfya | 351(a) | Rx | Licensed | 2019-01-28 |
| 2024-09-01 | 003 | Tremfya | 351(a) | Rx | Licensed | 2024-09-11 |
| 2024-09-01 | 004 | Tremfya | 351(a) | Rx | Licensed | 2024-09-11 |
| 2024-09-01 | 005 | Tremfya | 351(a) | Rx | Licensed | 2024-09-11 |
| 2020-05-01 | 001 | Tremfya | 351(a) | Rx | Licensed | 2017-07-13 |
| 2020-05-01 | 002 | Tremfya | 351(a) | Rx | Licensed | 2019-01-29 |