Inmazeb Purple Book BLA 761169
- BLA number
- 761169
- Proprietary names
- Inmazeb
- Proper names
- atoltivimab, maftivimab, and odesivimab-ebgn
- Applicant
- Regeneron Pharmaceuticals, Inc.
- Center
- CDER
- First observed release
- 2020-10-01
- 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 | Inmazeb | atoltivimab, maftivimab, and odesivimab-ebgn | 351(a) | 241.7MG, 241.7MG, 241.7MG/14.5ML (16.67MG, 16.67MG, 16.67MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2020-10-14 | |
| 002 | Inmazeb | atoltivimab, maftivimab, and odesivimab-ebgn | 351(a) | 483.3MG, 483.3MG, 483.3MG/14.5ML (33.33MG, 33.33MG, 33.33MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2021-09-29 | |
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 |
|---|
| 2022-05-01 | U | 002 | Inmazeb | 351(a) | Rx | Regeneron Pharmaceuticals, Inc. |
| 2021-03-01 | U | 001 | Inmazeb | 351(a) | Rx | Regeneron Pharmaceuticals, Inc. |
| 2020-10-01 | N | 001 | Inmazeb | 351(a) | Rx | Regeneron Pharmaceuticals, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2022-05-01 | 002 | Inmazeb | 351(a) | Rx | Licensed | 2021-09-29 |
| 2020-10-01 | 001 | Inmazeb | 351(a) | Rx | Licensed | 2020-10-14 |