Simponi Purple Book BLA 125289
- BLA number
- 125289
- Proprietary names
- Simponi
- Proper names
- golimumab
- 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
- 14 patents listed; 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 | Simponi | golimumab | 351(a) | 50MG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2009-04-24 | YES |
| 002 | Simponi | golimumab | 351(a) | 50MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2009-04-24 | YES |
| 003 | Simponi | golimumab | 351(a) | 100MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2013-05-15 | YES |
| 004 | Simponi | golimumab | 351(a) | 100MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2013-05-15 | YES |
Published Patent List#
Patent, Expiration, Source updated table| Patent | Expiration | Source updated |
|---|
| 11,225,516 | 2039-05-03 | 2025-06-11 |
| 10,421,986 | 2035-08-08 | 2025-06-11 |
| 8,956,830 | 2033-03-14 | 2025-06-11 |
| 9,217,168 | 2033-03-14 | 2025-06-11 |
| 9,487,810 | 2033-03-14 | 2025-06-11 |
| 9,663,810 | 2033-03-14 | 2025-06-11 |
| 11,633,546 | 2032-11-08 | 2025-06-11 |
| 12,139,735 | 2032-07-06 | 2025-06-11 |
| 8,852,889 | 2032-07-06 | 2025-06-11 |
| 9,475,858 | 2032-07-06 | 2025-06-11 |
| 9,170,249 | 2032-03-12 | 2025-06-11 |
| 9,890,410 | 2032-03-12 | 2025-06-11 |
| 10,500,348 | 2031-11-20 | 2025-06-11 |
| 8,017,325 | 2029-01-13 | 2025-06-11 |
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2026-04-01 | U | 001 | Simponi | 351(a) | Rx | Janssen Biotech, Inc. |
| 2026-04-01 | U | 002 | Simponi | 351(a) | Rx | Janssen Biotech, Inc. |
| 2026-04-01 | U | 003 | Simponi | 351(a) | Rx | Janssen Biotech, Inc. |
| 2026-04-01 | U | 004 | Simponi | 351(a) | Rx | Janssen Biotech, Inc. |
| 2025-06-01 | U | 001 | Simponi | 351(a) | Rx | Janssen Biotech, Inc. |
| 2025-06-01 | U | 002 | Simponi | 351(a) | Rx | Janssen Biotech, Inc. |
| 2025-06-01 | U | 003 | Simponi | 351(a) | Rx | Janssen Biotech, Inc. |
| 2025-06-01 | U | 004 | Simponi | 351(a) | Rx | Janssen Biotech, Inc. |
| 2020-05-01 | R | 001 | Simponi | 351(a) | Rx | Janssen Biotech, Inc. |
| 2020-05-01 | R | 002 | Simponi | 351(a) | Rx | Janssen Biotech, Inc. |
| 2020-05-01 | R | 003 | Simponi | 351(a) | Rx | Janssen Biotech, Inc. |
| 2020-05-01 | R | 004 | Simponi | 351(a) | Rx | Janssen Biotech, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-05-01 | 001 | Simponi | 351(a) | Rx | Licensed | 2009-04-24 |
| 2020-05-01 | 002 | Simponi | 351(a) | Rx | Licensed | 2009-04-24 |
| 2020-05-01 | 003 | Simponi | 351(a) | Rx | Licensed | 2013-05-15 |
| 2020-05-01 | 004 | Simponi | 351(a) | Rx | Licensed | 2013-05-15 |