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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
  1. 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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