Avastin Purple Book BLA 125085
- BLA number
- 125085
- Proprietary names
- Avastin
- Proper names
- bevacizumab
- Applicant
- Genentech, Inc.
- Center
- CDER
- First observed release
- 2020-02-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- FDA patent list
- 22 patents listed; 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 | Avastin | bevacizumab | 351(a) | 100MG/4ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2004-02-26 | YES |
| 002 | Avastin | bevacizumab | 351(a) | 400MG/16ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2004-02-26 | YES |
Biosimilar And Interchangeable Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761028 | Mvasi | bevacizumab-awwb | 351(k) Biosimilar | Rx | 2026-06-01 |
| 761099 | Zirabev | bevacizumab-bvzr | 351(k) Biosimilar | Rx | 2026-06-01 |
| 761175 | Jobevne | bevacizumab-nwgd | 351(k) Biosimilar | Rx | 2026-06-01 |
| 761198 | Avzivi | bevacizumab-tnjn | 351(k) Biosimilar | Rx | 2026-06-01 |
| 761231 | Alymsys | bevacizumab-maly | 351(k) Biosimilar | Rx | 2026-06-01 |
| 761268 | Vegzelma | bevacizumab-adcd | 351(k) Biosimilar | Rx | 2026-06-01 |
Published Patent List#
Patent, Expiration, Source updated table| Patent | Expiration | Source updated |
|---|
| 10,336,983 | 2035-07-31 | 2025-06-11 |
| 10,208,355 | 2035-07-14 | 2025-06-11 |
| 10,274,466 | 2035-07-11 | 2025-06-11 |
| 9,441,035 | 2034-04-23 | 2025-06-11 |
| 10,017,732 | 2034-03-14 | 2025-06-11 |
| 10,676,710 | 2034-03-14 | 2025-06-11 |
| 10,829,732 | 2034-03-14 | 2025-06-11 |
| 10,906,934 | 2033-10-12 | 2025-06-11 |
| 10,513,697 | 2032-09-17 | 2025-06-11 |
| 9,487,809 | 2032-01-14 | 2025-06-11 |
| 10,704,071 | 2031-08-18 | 2025-06-11 |
| 10,662,237 | 2031-08-07 | 2025-06-11 |
| 10,011,856 | 2031-05-26 | 2025-06-11 |
| 8,512,983 | 2031-01-04 | 2025-06-11 |
| 10,982,003 | 2030-08-06 | 2025-06-11 |
| 9,714,293 | 2030-08-06 | 2025-06-11 |
| 8,460,895 | 2029-08-08 | 2025-06-11 |
| 10,906,986 | 2028-07-08 | 2025-06-11 |
| 11,078,294 | 2028-07-08 | 2025-06-11 |
| 8,574,869 | 2028-07-08 | 2025-06-11 |
| 7,485,704 | 2025-03-08 | 2025-06-11 |
| 9,795,672 | 2024-05-28 | 2025-06-11 |
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2021-03-01 | U | 001 | Avastin | 351(a) | Rx | Genentech, Inc. |
| 2021-03-01 | U | 002 | Avastin | 351(a) | Rx | Genentech, Inc. |
| 2020-08-01 | U | 001 | Avastin | 351(a) | Rx | Genentech, Inc. |
| 2020-08-01 | U | 002 | Avastin | 351(a) | Rx | Genentech, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-05-01 | 001 | Avastin | 351(a) | Rx | Licensed | 2004-02-26 |
| 2020-05-01 | 002 | Avastin | 351(a) | Rx | Licensed | 2004-02-26 |
| 2020-02-01 | 001 | Avastin | 351(a) | Marketed | Licensed | 2004-02-26 |
| 2020-02-01 | 002 | Avastin | 351(a) | Marketed | Licensed | 2004-02-26 |