Purple Book reference family · 351(a) biologic
Immune Globulin Intravenous (Human), 10% Liquid (Privigen)
Immune Globulin Intravenous (Human), 10% Liquid is an FDA-licensed reference biologic from CSL Behring AG.
351(a) biologicBLA 125201 CSL Behring AG
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2007
Reference product
Originator biologic
351(a)BLA 125201
Privigen Immune Globulin Intravenous (Human), 10% Liquid
CSL Behring AG
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Immune Globulin Intravenous (Human), 10% Liquid product.
19 yr 3 mo ago
Immune Globulin Intravenous (Human), 10% 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 Intravenous (Human), 10% Liquid.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.

