Immune Globulin Subcutaneous (Human), 20% Liquid (Hizentra)
Immune Globulin Subcutaneous (Human), 20% Liquid is an FDA-licensed reference biologic from CSL Behring AG. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2010
Reference approved
Reference product
Hizentra Immune Globulin Subcutaneous (Human), 20% Liquid
CSL Behring AG
- Approved
- Mar 04, 2010
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Immune Globulin Subcutaneous (Human), 20% Liquid, in chronological order.
Reference approval
Approval date of the reference Immune Globulin Subcutaneous (Human), 20% Liquid product.
16 yr 6 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
1 yr 3 mo ago
Frequently asked questions
Are there biosimilars approved for Immune Globulin Subcutaneous (Human), 20% Liquid (Hizentra)?
No 351(k) biosimilars or interchangeable biosimilars referencing Immune Globulin Subcutaneous (Human), 20% Liquid are listed in the FDA Purple Book yet.
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