Purple Book reference family · 351(a) biologic
Immune Globulin Intravenous (Human) (Bivigam)
Immune Globulin Intravenous (Human) is an FDA-licensed reference biologic from ADMA Biologics, Inc..
351(a) biologicBLA 125389 ADMA Biologics, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2012
Reference product
Originator biologic
351(a)BLA 125389
Bivigam Immune Globulin Intravenous (Human)
ADMA Biologics, Inc.
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) product.
13 yr 11 mo ago
Immune Globulin Intravenous (Human): 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).
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