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
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 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 5 yr 7 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.
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Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.