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.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2025
Reference approved
Reference product
QIVIGY Immune Globulin Intravenous, Human-kthm, 10% Solution
Kedrion, S.p.A.
- Approved
- Sep 26, 2025
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Immune Globulin Intravenous, Human-kthm, 10% Solution, in chronological order.
Reference approval
Approval date of the reference Immune Globulin Intravenous, Human-kthm, 10% Solution product.
8 mo ago
Frequently asked questions
Are there biosimilars approved for Immune Globulin Intravenous, Human-kthm, 10% Solution (QIVIGY)?
No 351(k) biosimilars or interchangeable biosimilars referencing Immune Globulin Intravenous, Human-kthm, 10% Solution are listed in the FDA Purple Book yet.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.