iodinated I-131 albumin (Megatope)
iodinated I-131 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
Megatope iodinated I-131 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-131 albumin, in chronological order.
Reference approval
Approval date of the reference iodinated I-131 albumin product.
51 yr ago
Frequently asked questions
Are there biosimilars approved for iodinated I-131 albumin (Megatope)?
No 351(k) biosimilars or interchangeable biosimilars referencing iodinated I-131 albumin are listed in the FDA Purple Book yet.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.