Purple Book reference family · 351(a) biologic
Immune Globulin (Human) (Baygam, Gamastan S/D)
Immune Globulin (Human) is an FDA-licensed reference biologic from Grifols Therapeutics LLC.
351(a) biologicBLA 101134 Grifols Therapeutics LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1944
Reference product
Originator biologic
351(a)BLA 101134
Baygam, Gamastan S/D Immune Globulin (Human)
Grifols Therapeutics LLC
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 (Human) product.
83 yr 9 mo ago
Immune Globulin (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 (Human).
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