ibritumomab tiuxetan (Zevalin)
ibritumomab tiuxetan is an FDA-licensed reference biologic from Acrotech Biopharma Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2002
Reference approved
Reference product
Zevalin ibritumomab tiuxetan
Acrotech Biopharma Inc.
- Approved
- Feb 19, 2002
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for ibritumomab tiuxetan, in chronological order.
Reference approval
Approval date of the reference ibritumomab tiuxetan product.
24 yr 8 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
17 yr 6 mo ago
Frequently asked questions
Are there biosimilars approved for ibritumomab tiuxetan (Zevalin)?
No 351(k) biosimilars or interchangeable biosimilars referencing ibritumomab tiuxetan are listed in the FDA Purple Book yet.
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