Arzerra Purple Book BLA 125326
- BLA number
- 125326
- Proprietary names
- Arzerra, Kesimpta
- Proper names
- ofatumumab
- Applicant
- Novartis Pharmaceuticals Corporation
- 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 | Arzerra | ofatumumab | 351(a) | 100MG/5ML | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | 2009-10-26 | |
| 002 | Arzerra | ofatumumab | 351(a) | 1,000MG/50ML | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | 2011-04-01 | |
| 003 | Kesimpta | ofatumumab | 351(a) | 20MG/0.4ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2020-08-20 | |
| 004 | Kesimpta | ofatumumab | 351(a) | 20MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | 2020-08-20 | |
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 |
|---|
| 2023-07-01 | U | 001 | Arzerra | 351(a) | Disc | Novartis Pharmaceuticals Corporation |
| 2023-07-01 | U | 002 | Arzerra | 351(a) | Disc | Novartis Pharmaceuticals Corporation |
| 2023-06-01 | U | 004 | Kesimpta | 351(a) | Disc | Novartis Pharmaceuticals Corporation |
| 2020-08-01 | U | 001 | Arzerra | 351(a) | Rx | Novartis Pharmaceuticals Corporation |
| 2020-08-01 | U | 002 | Arzerra | 351(a) | Rx | Novartis Pharmaceuticals Corporation |
| 2020-08-01 | N | 003 | Kesimpta | 351(a) | Rx | Novartis Pharmaceuticals Corporation |
| 2020-08-01 | N | 004 | Kesimpta | 351(a) | Rx | Novartis Pharmaceuticals Corporation |
| 2020-05-01 | R | 001 | Arzerra | 351(a) | Rx | Novartis Pharmaceuticals Corporation |
| 2020-05-01 | R | 002 | Arzerra | 351(a) | Rx | Novartis Pharmaceuticals Corporation |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2023-07-01 | 001 | Arzerra | 351(a) | Disc | Licensed | 2009-10-26 |
| 2023-07-01 | 002 | Arzerra | 351(a) | Disc | Licensed | 2011-04-01 |
| 2023-06-01 | 004 | Kesimpta | 351(a) | Disc | Licensed | 2020-08-20 |
| 2020-08-01 | 003 | Kesimpta | 351(a) | Rx | Licensed | 2020-08-20 |
| 2020-08-01 | 004 | Kesimpta | 351(a) | Rx | Licensed | 2020-08-20 |
| 2020-05-01 | 001 | Arzerra | 351(a) | Rx | Licensed | 2009-10-26 |
| 2020-05-01 | 002 | Arzerra | 351(a) | Rx | Licensed | 2011-04-01 |