zanidatamab-hrii (Ziihera)
zanidatamab-hrii is an FDA-licensed reference biologic from Jazz Pharmaceuticals Ireland Limited. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2024
Reference approved
Reference product
Ziihera zanidatamab-hrii
Jazz Pharmaceuticals Ireland Limited
- Approved
- Nov 20, 2024
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for zanidatamab-hrii from the RCSB Protein Data Bank (PDB 8FFJ).
Interactive biological assembly from PDB entry 8FFJ. 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 zanidatamab-hrii, in chronological order.
Reference approval
Approval date of the reference zanidatamab-hrii product.
1 yr 8 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 5 yr 5 mo
Frequently asked questions
Are there biosimilars approved for zanidatamab-hrii (Ziihera)?
No 351(k) biosimilars or interchangeable biosimilars referencing zanidatamab-hrii 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.