Enbrel Purple Book BLA 103795
- BLA number
- 103795
- Proprietary names
- Enbrel, Enbrel Mini
- Proper names
- etanercept
- Applicant
- Immunex Corporation
- Center
- CDER
- First observed release
- 2020-02-01
- 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 | Enbrel | etanercept | 351(a) | 25MG | For Injection | Subcutaneous | Single-Dose Vial | Disc | Licensed | 1998-11-02 | |
| 002 | Enbrel | etanercept | 351(a) | 25MG | For Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | 1999-05-27 | |
| 003 | Enbrel | etanercept | 351(a) | 50MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2004-09-27 | |
| 004 | Enbrel | etanercept | 351(a) | 25MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2007-02-01 | |
| 005 | Enbrel Mini | etanercept | 351(a) | 50MG/ML | Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | 2017-09-14 | |
| 006 | Enbrel | etanercept | 351(a) | 50MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | | |
| 007 | Enbrel | etanercept | 351(a) | 25MG/0.5ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | 2020-03-05 | |
Biosimilar And Interchangeable Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761042 | Erelzi | etanercept-szzs | 351(k) Biosimilar | Disc | 2026-06-01 |
| 761066 | Eticovo | etanercept-ykro | 351(k) Interchangeable | Disc | 2026-06-01 |
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 |
|---|
| 2021-03-01 | U | 001 | Enbrel | 351(a) | Disc | Immunex Corporation |
| 2020-08-01 | U | 001 | Enbrel | 351(a) | Rx | Immunex Corporation |
| 2020-08-01 | U | 002 | Enbrel | 351(a) | Rx | Immunex Corporation |
| 2020-08-01 | U | 003 | Enbrel | 351(a) | Rx | Immunex Corporation |
| 2020-08-01 | U | 004 | Enbrel | 351(a) | Rx | Immunex Corporation |
| 2020-08-01 | U | 005 | Enbrel Mini | 351(a) | Rx | Immunex Corporation |
| 2020-08-01 | U | 006 | Enbrel | 351(a) | Rx | Immunex Corporation |
| 2020-08-01 | U | 007 | Enbrel | 351(a) | Rx | Immunex Corporation |
| 2020-05-01 | U | 005 | Enbrel Mini | 351(a) | Rx | Immunex Corporation |
| 2020-05-01 | U | 006 | Enbrel | 351(a) | Rx | Immunex Corporation |
| 2020-03-01 | N | 007 | Enbrel | 351(a) | Marketed | Immunex Corporation |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2021-03-01 | 001 | Enbrel | 351(a) | Disc | Licensed | 1998-11-02 |
| 2020-05-01 | 001 | Enbrel | 351(a) | Rx | Licensed | 1998-11-02 |
| 2020-05-01 | 002 | Enbrel | 351(a) | Rx | Licensed | 1999-05-27 |
| 2020-05-01 | 003 | Enbrel | 351(a) | Rx | Licensed | 2004-09-27 |
| 2020-05-01 | 004 | Enbrel | 351(a) | Rx | Licensed | 2007-02-01 |
| 2020-05-01 | 005 | Enbrel Mini | 351(a) | Rx | Licensed | 2017-09-14 |
| 2020-05-01 | 006 | Enbrel | 351(a) | Rx | Licensed | |
| 2020-05-01 | 007 | Enbrel | 351(a) | Rx | Licensed | 2020-03-05 |
| 2020-03-01 | 007 | Enbrel | 351(a) | Marketed | Licensed | 2020-03-05 |
| 2020-02-01 | 001 | Enbrel | 351(a) | Marketed | Licensed | 1998-11-02 |
| 2020-02-01 | 002 | Enbrel | 351(a) | Marketed | Licensed | 1999-05-27 |
| 2020-02-01 | 003 | Enbrel | 351(a) | Marketed | Licensed | 2004-09-27 |
| 2020-02-01 | 004 | Enbrel | 351(a) | Marketed | Licensed | 2007-02-01 |
| 2020-02-01 | 005 | Enbrel | 351(a) | Marketed | Licensed | |
| 2020-02-01 | 006 | Enbrel | 351(a) | Marketed | Licensed | 2017-09-14 |