Purple Book reference family · 351(a) biologic
Immune Globulin Infusion (Human) (Gammagard Liquid)
Immune Globulin Infusion (Human) is an FDA-licensed reference biologic from Takeda Pharmaceuticals U.S.A., Inc..
351(a) biologicBLA 125105 Takeda Pharmaceuticals U.S.A., Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2005
Reference product
Originator biologic
351(a)BLA 125105
Gammagard Liquid Immune Globulin Infusion (Human)
Takeda Pharmaceuticals U.S.A., 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 Infusion (Human) product.
21 yr 9 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
7 yr 4 mo ago
Immune Globulin Infusion (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 Infusion (Human).
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
