trastuzumab (Herceptin)
trastuzumab is an FDA-licensed reference biologic from Genentech, Inc., with 6 approved follow-on biologics. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
6
Biosimilars
0
Interchangeables
4
Listed patents
1998
Reference approved
Reference product
Herceptin trastuzumab
Genentech, Inc.
- Approved
- Sep 25, 1998
- Marketing
- Disc*
- Center
- CDER
- Patents
- 4 listed
Molecular structure
Experimental 3D structure for trastuzumab from the RCSB Protein Data Bank (PDB 9N8Q).
Interactive biological assembly from PDB entry 9N8Q. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for trastuzumab, in chronological order.
Reference approval
Approval date of the reference trastuzumab product.
28 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
8 yr 9 mo ago
Patent 10,808,037 expires
Published Purple Book patent expiration.
in 2 yr 2 mo
Patent 11,078,294 expires
Published Purple Book patent expiration.
in 2 yr 2 mo
Patent 8,574,869 expires
Published Purple Book patent expiration.
in 2 yr 2 mo
Patent 10,662,237 expires
Published Purple Book patent expiration.
in 5 yr 3 mo
Biosimilars & interchangeables for trastuzumab
6 FDA-licensed follow-on biologics referencing trastuzumab.
| Product | Proper name | Applicant | Type | BLA | Approved |
|---|---|---|---|---|---|
| Ogivri | trastuzumab-dkst | Biocon Biologics Inc. | Biosimilar 351(k) | 761074 | Dec 01, 2017 |
| Herzuma | trastuzumab-pkrb | CELLTRION, Inc. | Biosimilar 351(k) | 761091 | May 16, 2019 |
| Kanjinti | trastuzumab-anns | Amgen Inc. | Biosimilar 351(k) | 761073 | Jun 13, 2019 |
| Ontruzant | trastuzumab-dttb | Samsung Bioepis Co., Ltd. | Biosimilar 351(k) | 761100 | Mar 20, 2020 |
| Trazimera | trastuzumab-qyyp | Pfizer Ireland Pharmaceuticals Unlimited Company | Biosimilar 351(k) | 761081 | Nov 30, 2020 |
| Hercessi | trastuzumab-strf | Accord BioPharma Inc. | Biosimilar 351(k) | 761346 | Apr 25, 2024 |
Published patents
Patents the BLA holder has published in the FDA Purple Book Patent List for trastuzumab.
| Patent | Expires | In |
|---|---|---|
| 10,808,037 | Jul 08, 2028 | in 2 yr 2 mo |
| 11,078,294 | Jul 08, 2028 | in 2 yr 2 mo |
| 8,574,869 | Jul 08, 2028 | in 2 yr 2 mo |
| 10,662,237 | Aug 07, 2031 | in 5 yr 3 mo |
Frequently asked questions
What biosimilars are approved for trastuzumab (Herceptin)?
The FDA Purple Book lists 6 approved follow-on biologics referencing trastuzumab: Ogivri, Herzuma, Kanjinti, Ontruzant, Trazimera, and Hercessi. Of these, 0 are interchangeable biosimilars and 6 are 351(k) biosimilars.
Who makes trastuzumab biosimilars?
Companies with FDA-approved follow-on biologics referencing trastuzumab include Biocon Biologics Inc., CELLTRION, Inc., Amgen Inc., Samsung Bioepis Co., Ltd., Pfizer Ireland Pharmaceuticals Unlimited Company, and Accord BioPharma Inc..
How many patents are listed for trastuzumab (Herceptin) in the Purple Book?
4 patents are published in the FDA Purple Book Patent List for trastuzumab.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.