iodinated I-125 albumin (Jeanatope)
iodinated I-125 albumin is an FDA-licensed reference biologic from Iso-Tex Diagnostics, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1976
Reference approved
Reference product
Jeanatope iodinated I-125 albumin
Iso-Tex Diagnostics, Inc.
- Approved
- Feb 23, 1976
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for iodinated I-125 albumin, in chronological order.
Reference approval
Approval date of the reference iodinated I-125 albumin product.
51 yr ago
Frequently asked questions
Are there biosimilars approved for iodinated I-125 albumin (Jeanatope)?
No 351(k) biosimilars or interchangeable biosimilars referencing iodinated I-125 albumin are listed in the FDA Purple Book yet.
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