Purple Book reference family · 351(a) biologic
immune globulin intravenous, human-stwk (Alyglo)
immune globulin intravenous, human-stwk is an FDA-licensed reference biologic from GC Biopharma Corp..
351(a) biologicBLA 125743 GC Biopharma Corp.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2023
Reference product
Originator biologic
351(a)BLA 125743
Alyglo immune globulin intravenous, human-stwk
GC Biopharma Corp.
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-stwk product.
2 yr 8 mo ago
immune globulin intravenous, human-stwk: 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-stwk.
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