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
2023
Reference approved
Reference product
Hizentra Immune Globulin Subcutaneous (Human), 20% Liquid
CSL Behring AG
- Approved
- Apr 13, 2023
- 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.
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
8 yr 1 mo ago
Reference approval
Approval date of the reference Immune Globulin Subcutaneous (Human), 20% Liquid product.
3 yr 4 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.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.