Immune Globulin Subcutaneous (Human), 20% Solution (Cuvitru)
Immune Globulin Subcutaneous (Human), 20% Solution is an FDA-licensed reference biologic from Takeda Pharmaceuticals U.S.A., Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2016
Reference approved
Reference product
Cuvitru Immune Globulin Subcutaneous (Human), 20% Solution
Takeda Pharmaceuticals U.S.A., Inc.
- Approved
- Sep 13, 2016
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Immune Globulin Subcutaneous (Human), 20% Solution, in chronological order.
Reference approval
Approval date of the reference Immune Globulin Subcutaneous (Human), 20% Solution product.
9 yr 10 mo ago
Frequently asked questions
Are there biosimilars approved for Immune Globulin Subcutaneous (Human), 20% Solution (Cuvitru)?
No 351(k) biosimilars or interchangeable biosimilars referencing Immune Globulin Subcutaneous (Human), 20% Solution are listed in the FDA Purple Book yet.
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