Purple Book reference family · 351(a) biologic
immune globulin intravenous, human-dira (YIMMUGO)
immune globulin intravenous, human-dira is an FDA-licensed reference biologic from Biotest AG.
351(a) biologicBLA 125810 Biotest AG
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2024
Reference product
Originator biologic
351(a)BLA 125810
YIMMUGO immune globulin intravenous, human-dira
Biotest AG
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference immune globulin intravenous, human-dira product.
2 yr 2 mo ago
immune globulin intravenous, human-dira: 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 immune globulin intravenous, human-dira.
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