Purple Book reference family · 351(a) biologic
iodinated I-131 albumin (Megatope)
iodinated I-131 albumin is an FDA-licensed reference biologic from Iso-Tex Diagnostics, Inc..
351(a) biologicBLA 017837 Iso-Tex Diagnostics, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1976
Reference product
Originator biologic
351(a)BLA 017837
Megatope iodinated I-131 albumin
Iso-Tex Diagnostics, Inc.
View full reference-product record- Approved
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference iodinated I-131 albumin product.
51 yr 2 mo ago
iodinated I-131 albumin: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for iodinated I-131 albumin.
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