Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified (Gammaked, Gamunex-C)
Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified is an FDA-licensed reference biologic from Grifols Therapeutics LLC. 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
Gammaked, Gamunex-C Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified
Grifols Therapeutics LLC
- Approved
- Oct 20, 2025
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified, in chronological order.
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
11 yr ago
Reference approval
Approval date of the reference Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified product.
9 mo ago
Frequently asked questions
Are there biosimilars approved for Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified (Gammaked, Gamunex-C)?
No 351(k) biosimilars or interchangeable biosimilars referencing Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified are listed in the FDA Purple Book yet.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.