trastuzumab and hyaluronidase-oysk (Herceptin Hylecta)
trastuzumab and hyaluronidase-oysk is an FDA-licensed reference biologic from Genentech, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2019
Reference approved
Reference product
Herceptin Hylecta trastuzumab and hyaluronidase-oysk
Genentech, Inc.
- Approved
- Feb 28, 2019
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for trastuzumab and hyaluronidase-oysk from the RCSB Protein Data Bank (PDB 1N8Z).
Interactive biological assembly from PDB entry 1N8Z. 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 and hyaluronidase-oysk, in chronological order.
Reference approval
Approval date of the reference trastuzumab and hyaluronidase-oysk product.
7 yr 6 mo ago
Frequently asked questions
Are there biosimilars approved for trastuzumab and hyaluronidase-oysk (Herceptin Hylecta)?
No 351(k) biosimilars or interchangeable biosimilars referencing trastuzumab and hyaluronidase-oysk are listed in the FDA Purple Book yet.
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.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.