Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase (Hyqvia)
Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase 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
2014
Reference approved
Reference product
Hyqvia Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase
Takeda Pharmaceuticals U.S.A., Inc.
- Approved
- Sep 12, 2014
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase, in chronological order.
Reference approval
Approval date of the reference Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase product.
11 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 4 yr 8 mo
Frequently asked questions
Are there biosimilars approved for Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase (Hyqvia)?
No 351(k) biosimilars or interchangeable biosimilars referencing Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase are listed in the FDA Purple Book yet.
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