Immune Globulin Intravenous (Human) (Bivigam)
Immune Globulin Intravenous (Human) is an FDA-licensed reference biologic from ADMA Biologics, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2012
Reference approved
Reference product
Bivigam Immune Globulin Intravenous (Human)
ADMA Biologics, Inc.
- Approved
- Dec 19, 2012
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Immune Globulin Intravenous (Human), in chronological order.
Reference approval
Approval date of the reference Immune Globulin Intravenous (Human) product.
13 yr 8 mo ago
Frequently asked questions
Are there biosimilars approved for Immune Globulin Intravenous (Human) (Bivigam)?
No 351(k) biosimilars or interchangeable biosimilars referencing Immune Globulin Intravenous (Human) are listed in the FDA Purple Book yet.
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