Herceptin Purple Book BLA 103792
- BLA number
- 103792
- Proprietary names
- Herceptin
- Proper names
- trastuzumab
- 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
- 4 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 | Herceptin | trastuzumab | 351(a) | 420MG | For Injection | Intravenous | Multi-Dose Vial | Disc* | Licensed | 1998-09-25 | YES |
| 002 | Herceptin | trastuzumab | 351(a) | 150MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2017-02-10 | YES |
Biosimilar And Interchangeable Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761073 | Kanjinti | trastuzumab-anns | 351(k) Biosimilar | Rx | 2026-06-01 |
| 761074 | Ogivri | trastuzumab-dkst | 351(k) Biosimilar | Rx | 2026-06-01 |
| 761081 | Trazimera | trastuzumab-qyyp | 351(k) Biosimilar | Rx | 2026-06-01 |
| 761091 | Herzuma | trastuzumab-pkrb | 351(k) Biosimilar | Rx | 2026-06-01 |
| 761100 | Ontruzant | trastuzumab-dttb | 351(k) Biosimilar | Rx | 2026-06-01 |
| 761346 | Hercessi | trastuzumab-strf | 351(k) Biosimilar | Rx | 2026-06-01 |
Published Patent List#
Patent, Expiration, Source updated table| Patent | Expiration | Source updated |
|---|
| 10,662,237 | 2031-08-07 | 2025-06-11 |
| 10,808,037 | 2028-07-08 | 2025-06-11 |
| 11,078,294 | 2028-07-08 | 2025-06-11 |
| 8,574,869 | 2028-07-08 | 2025-06-11 |
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2024-11-01 | U | 001 | Herceptin | 351(a) | Disc* | Genentech, Inc. |
| 2023-07-01 | U | 001 | Herceptin | 351(a) | Disc | Genentech, Inc. |
| 2023-07-01 | U | 002 | Herceptin | 351(a) | Rx | Genentech, Inc. |
| 2022-10-01 | U | 001 | Herceptin | 351(a) | Disc | Genentech, Inc. |
| 2020-08-01 | U | 001 | Herceptin | 351(a) | Rx | Genentech, Inc. |
| 2020-08-01 | U | 002 | Herceptin | 351(a) | Rx | Genentech, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2024-11-01 | 001 | Herceptin | 351(a) | Disc* | Licensed | 1998-09-25 |
| 2022-10-01 | 001 | Herceptin | 351(a) | Disc | Licensed | 1998-09-25 |
| 2020-05-01 | 001 | Herceptin | 351(a) | Rx | Licensed | 1998-09-25 |
| 2020-05-01 | 002 | Herceptin | 351(a) | Rx | Licensed | 2017-02-10 |
| 2020-02-01 | 001 | Herceptin | 351(a) | Marketed | Licensed | 1998-09-25 |
| 2020-02-01 | 002 | Herceptin | 351(a) | Marketed | Licensed | 2017-02-10 |