Rituxan Purple Book BLA 103705
- BLA number
- 103705
- Proprietary names
- Rituxan
- Proper names
- rituximab
- 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
- 15 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 | Rituxan | rituximab | 351(a) | 100MG/10ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 1997-11-26 | YES |
| 002 | Rituxan | rituximab | 351(a) | 500MG/50ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 1997-11-26 | YES |
Published Patent List#
Patent, Expiration, Source updated table| Patent | Expiration | Source updated |
|---|
| 10,336,983 | 2035-07-31 | 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 |
| 10,662,237 | 2031-08-07 | 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 |
| 10,759,866 | 2028-07-08 | 2025-06-11 |
| 8,574,869 | 2028-07-08 | 2025-06-11 |
| 10,450,379 | 2026-11-14 | 2025-06-11 |
| 10,654,940 | 2026-11-14 | 2025-06-11 |
| 7,976,838 | 2025-06-30 | 2025-06-11 |
| 7,485,704 | 2025-03-08 | 2025-06-11 |
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2023-11-01 | U | 001 | Rituxan | 351(a) | Rx | Genentech, Inc. |
| 2023-11-01 | U | 002 | Rituxan | 351(a) | Rx | Genentech, Inc. |
| 2023-01-01 | U | 001 | Rituxan | 351(a) | Rx | Genentech, Inc. |
| 2023-01-01 | U | 002 | Rituxan | 351(a) | Rx | Genentech, Inc. |
| 2020-08-01 | U | 001 | Rituxan | 351(a) | Rx | Genentech, Inc. |
| 2020-08-01 | U | 002 | Rituxan | 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 | Rituxan | 351(a) | Rx | Licensed | 1997-11-26 |
| 2020-05-01 | 002 | Rituxan | 351(a) | Rx | Licensed | 1997-11-26 |
| 2020-02-01 | 001 | Rituxan | 351(a) | Marketed | Licensed | 1997-11-26 |
| 2020-02-01 | 002 | Rituxan | 351(a) | Marketed | Licensed | 1997-11-26 |