immune globulin intravenous, human-dira (YIMMUGO)
immune globulin intravenous, human-dira is an FDA-licensed reference biologic from Biotest AG. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2024
Reference approved
Reference product
YIMMUGO immune globulin intravenous, human-dira
Biotest AG
- Approved
- Jun 13, 2024
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for immune globulin intravenous, human-dira, in chronological order.
Reference approval
Approval date of the reference immune globulin intravenous, human-dira product.
2 yr ago
Frequently asked questions
Are there biosimilars approved for immune globulin intravenous, human-dira (YIMMUGO)?
No 351(k) biosimilars or interchangeable biosimilars referencing immune globulin intravenous, human-dira are listed in the FDA Purple Book yet.
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