Purple Book product · Biosimilar 351(k)
Ontruzant
trastuzumab-dttb
Mar 20, 2020
Approved
Biosimilar 351(k)
License type
Rx
Marketing
4
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Mar 20, 2020
6 yr 5 mo ago
Today
Pharmaceutical detail
Strength
420MG
Dosage form
For Injection
Route
Intravenous
Presentation
Multi-Dose Vial
Center
CDER
License number
2046
Product number
002
Submission type
Supplement
Supplement number
5
Change type
Not listed
Reference product family
View full familyBiosimilar of trastuzumab (Herceptin)
Patent list (4)
Source provenance
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
When do Ontruzant's patents expire?
The FDA Purple Book lists 4 published patents for Ontruzant, with the last listed patent expiring Aug 07, 2031. Every patent below links to its FDA source record so you can verify the expiration date.
Is Ontruzant a biosimilar?
Yes. Ontruzant is a Biosimilar 351(k) referencing trastuzumab, licensed under a 351(k) BLA.
Is Ontruzant interchangeable?
Ontruzant is a 351(k) biosimilar but does not carry an interchangeability designation in the Purple Book, so pharmacy-level substitution depends on state law.
What is Ontruzant's BLA number?
Ontruzant is licensed under BLA 761100, held by Samsung Bioepis Co., Ltd..
When was Ontruzant approved by the FDA?
Ontruzant was approved by the FDA on Mar 20, 2020.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
