Immune Globulin Infusion (Human) (Gammagard Liquid)
Immune Globulin Infusion (Human) 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
2005
Reference approved
Reference product
Gammagard Liquid Immune Globulin Infusion (Human)
Takeda Pharmaceuticals U.S.A., Inc.
- Approved
- Apr 27, 2005
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Immune Globulin Infusion (Human), in chronological order.
Reference approval
Approval date of the reference Immune Globulin Infusion (Human) product.
21 yr 5 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
7 yr 1 mo ago
Frequently asked questions
Are there biosimilars approved for Immune Globulin Infusion (Human) (Gammagard Liquid)?
No 351(k) biosimilars or interchangeable biosimilars referencing Immune Globulin Infusion (Human) are listed in the FDA Purple Book yet.
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