Mircera Purple Book BLA 125164
- BLA number
- 125164
- Proprietary names
- Mircera
- Proper names
- methoxy polyethylene glycol-epoetin beta
- Applicant
- Vifor (International) 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 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 30MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2016-04-28 | |
| 002 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 50MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2007-11-14 | |
| 003 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 75MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2007-11-14 | |
| 004 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 100MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2007-11-14 | |
| 005 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 120MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2016-04-28 | |
| 006 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 150MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2007-11-14 | |
| 007 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 200MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2007-11-14 | |
| 008 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 250MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2007-11-14 | |
| 009 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 360MCG/0.6ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2016-04-28 | |
| 010 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 50MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | 2007-11-14 | |
| 011 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 100MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | 2007-11-14 | |
| 012 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 200MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | 2007-11-14 | |
| 013 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 300MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | 2007-11-14 | |
| 014 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 400MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | 2007-11-14 | |
| 015 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 600MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | 2007-11-14 | |
| 016 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 1,000MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | 2007-11-14 | |
| 017 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 400MCG/0.6ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Disc | Licensed | 2007-11-14 | |
| 018 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 600MCG/0.6ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Disc | Licensed | 2007-11-14 | |
| 019 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 800MCG/0.6ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Disc | Licensed | 2007-11-14 | |
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 | Mircera | 351(a) | Rx | Vifor (International) Inc. |
| 2020-05-01 | R | 002 | Mircera | 351(a) | Rx | Vifor (International) Inc. |
| 2020-05-01 | R | 003 | Mircera | 351(a) | Rx | Vifor (International) Inc. |
| 2020-05-01 | R | 004 | Mircera | 351(a) | Rx | Vifor (International) Inc. |
| 2020-05-01 | R | 005 | Mircera | 351(a) | Rx | Vifor (International) Inc. |
| 2020-05-01 | R | 006 | Mircera | 351(a) | Rx | Vifor (International) Inc. |
| 2020-05-01 | R | 007 | Mircera | 351(a) | Rx | Vifor (International) Inc. |
| 2020-05-01 | R | 008 | Mircera | 351(a) | Rx | Vifor (International) Inc. |
| 2020-05-01 | R | 009 | Mircera | 351(a) | Rx | Vifor (International) Inc. |
| 2020-05-01 | R | 010 | Mircera | 351(a) | Disc | Vifor (International) Inc. |
| 2020-05-01 | R | 011 | Mircera | 351(a) | Disc | Vifor (International) Inc. |
| 2020-05-01 | R | 012 | Mircera | 351(a) | Disc | Vifor (International) Inc. |
| 2020-05-01 | R | 013 | Mircera | 351(a) | Disc | Vifor (International) Inc. |
| 2020-05-01 | R | 014 | Mircera | 351(a) | Disc | Vifor (International) Inc. |
| 2020-05-01 | R | 015 | Mircera | 351(a) | Disc | Vifor (International) Inc. |
| 2020-05-01 | R | 016 | Mircera | 351(a) | Disc | Vifor (International) Inc. |
| 2020-05-01 | R | 017 | Mircera | 351(a) | Disc | Vifor (International) Inc. |
| 2020-05-01 | R | 018 | Mircera | 351(a) | Disc | Vifor (International) Inc. |
| 2020-05-01 | R | 019 | Mircera | 351(a) | Disc | Vifor (International) Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-05-01 | 001 | Mircera | 351(a) | Rx | Licensed | 2016-04-28 |
| 2020-05-01 | 002 | Mircera | 351(a) | Rx | Licensed | 2007-11-14 |
| 2020-05-01 | 003 | Mircera | 351(a) | Rx | Licensed | 2007-11-14 |
| 2020-05-01 | 004 | Mircera | 351(a) | Rx | Licensed | 2007-11-14 |
| 2020-05-01 | 005 | Mircera | 351(a) | Rx | Licensed | 2016-04-28 |
| 2020-05-01 | 006 | Mircera | 351(a) | Rx | Licensed | 2007-11-14 |
| 2020-05-01 | 007 | Mircera | 351(a) | Rx | Licensed | 2007-11-14 |
| 2020-05-01 | 008 | Mircera | 351(a) | Rx | Licensed | 2007-11-14 |
| 2020-05-01 | 009 | Mircera | 351(a) | Rx | Licensed | 2016-04-28 |
| 2020-05-01 | 010 | Mircera | 351(a) | Disc | Licensed | 2007-11-14 |
| 2020-05-01 | 011 | Mircera | 351(a) | Disc | Licensed | 2007-11-14 |
| 2020-05-01 | 012 | Mircera | 351(a) | Disc | Licensed | 2007-11-14 |
| 2020-05-01 | 013 | Mircera | 351(a) | Disc | Licensed | 2007-11-14 |
| 2020-05-01 | 014 | Mircera | 351(a) | Disc | Licensed | 2007-11-14 |
| 2020-05-01 | 015 | Mircera | 351(a) | Disc | Licensed | 2007-11-14 |
| 2020-05-01 | 016 | Mircera | 351(a) | Disc | Licensed | 2007-11-14 |
| 2020-05-01 | 017 | Mircera | 351(a) | Disc | Licensed | 2007-11-14 |
| 2020-05-01 | 018 | Mircera | 351(a) | Disc | Licensed | 2007-11-14 |
| 2020-05-01 | 019 | Mircera | 351(a) | Disc | Licensed | 2007-11-14 |