Purple Book reference family · 351(a) biologic
Immune Globulin Intravenous, Human-kthm, 10% Solution (QIVIGY)
Immune Globulin Intravenous, Human-kthm, 10% Solution is an FDA-licensed reference biologic from Kedrion, S.p.A..
351(a) biologicBLA 125822 Kedrion, S.p.A.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2025
Reference product
Originator biologic
351(a)BLA 125822
QIVIGY Immune Globulin Intravenous, Human-kthm, 10% Solution
Kedrion, S.p.A.
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-kthm, 10% Solution product.
10 mo ago
Immune Globulin Intravenous, Human-kthm, 10% Solution: 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-kthm, 10% Solution.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 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.
