Octagam Purple Book BLA 125062
- BLA number
- 125062
- Proprietary names
- Octagam
- Proper names
- Immune Globulin Intravenous (Human)
- Applicant
- Octapharma Pharmazeutika Produktionsges.m.b.H.
- Center
- CBER
- 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 | Octagam | Immune Globulin Intravenous (Human) | 351(a) | 5% 5.0G | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | 2004-05-21 | |
| 002 | Octagam | Immune Globulin Intravenous (Human) | 351(a) | 5% 1.0G | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | 2004-05-21 | |
| 003 | Octagam | Immune Globulin Intravenous (Human) | 351(a) | 5% 10G | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | 2004-05-21 | |
| 004 | Octagam | Immune Globulin Intravenous (Human) | 351(a) | 5% 2.5G | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | 2004-05-21 | |
| 005 | Octagam | Immune Globulin Intravenous (Human) | 351(a) | 5% 25G | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | 2007-03-26 | |
| 006 | Octagam | Immune Globulin Intravenous (Human) | 351(a) | 10% 20G | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | 2014-07-11 | |
| 007 | Octagam | Immune Globulin Intravenous (Human) | 351(a) | 10% 5G | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | 2014-07-11 | |
| 008 | Octagam | Immune Globulin Intravenous (Human) | 351(a) | 10% 2G | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | 2014-07-11 | |
| 009 | Octagam | Immune Globulin Intravenous (Human) | 351(a) | 10% 10G | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | 2014-07-11 | |
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 |
|---|
| 2021-09-01 | U | 001 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2021-09-01 | U | 002 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2021-09-01 | U | 003 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2021-09-01 | U | 004 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2021-09-01 | U | 005 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2021-09-01 | U | 006 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2021-09-01 | U | 007 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2021-09-01 | U | 008 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2021-09-01 | U | 009 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2021-05-01 | U | 001 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2021-05-01 | U | 002 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2021-05-01 | U | 003 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2021-05-01 | U | 004 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2021-05-01 | U | 005 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2021-05-01 | U | 006 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2021-05-01 | U | 007 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2021-05-01 | U | 008 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2021-05-01 | U | 009 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2020-08-01 | R | 001 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2020-08-01 | R | 002 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2020-08-01 | R | 003 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2020-08-01 | R | 004 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2020-08-01 | R | 005 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2020-08-01 | R | 006 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2020-08-01 | R | 007 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2020-08-01 | R | 008 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| 2020-08-01 | R | 009 | Octagam | 351(a) | Rx | Octapharma Pharmazeutika Produktionsges.m.b.H. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-08-01 | 001 | Octagam | 351(a) | Rx | Licensed | 2004-05-21 |
| 2020-08-01 | 002 | Octagam | 351(a) | Rx | Licensed | 2004-05-21 |
| 2020-08-01 | 003 | Octagam | 351(a) | Rx | Licensed | 2004-05-21 |
| 2020-08-01 | 004 | Octagam | 351(a) | Rx | Licensed | 2004-05-21 |
| 2020-08-01 | 005 | Octagam | 351(a) | Rx | Licensed | 2007-03-26 |
| 2020-08-01 | 006 | Octagam | 351(a) | Rx | Licensed | 2014-07-11 |
| 2020-08-01 | 007 | Octagam | 351(a) | Rx | Licensed | 2014-07-11 |
| 2020-08-01 | 008 | Octagam | 351(a) | Rx | Licensed | 2014-07-11 |
| 2020-08-01 | 009 | Octagam | 351(a) | Rx | Licensed | 2014-07-11 |