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 product
Gammaked, Gamunex-C Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified
Grifols Therapeutics LLC
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
11 yr 2 mo ago
Reference approval
Approval date of the reference Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified product.
11 mo ago
Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified: 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 Injection (Human) 10% Caprylate/Chromatography Purified.
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.
