Purple Book reference family · 351(a) biologic
Immune Globulin Subcutaneous (Human), 20% Liquid (Hizentra)
Immune Globulin Subcutaneous (Human), 20% Liquid is an FDA-licensed reference biologic from CSL Behring AG.
351(a) biologicBLA 125350 CSL Behring AG
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2023
Reference product
Originator biologic
351(a)BLA 125350
Hizentra Immune Globulin Subcutaneous (Human), 20% Liquid
CSL Behring AG
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
8 yr 3 mo ago
Reference approval
Approval date of the reference Immune Globulin Subcutaneous (Human), 20% Liquid product.
3 yr 6 mo ago
Immune Globulin Subcutaneous (Human), 20% Liquid: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for Immune Globulin Subcutaneous (Human), 20% Liquid.
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