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
2003
Reference approved
Reference product
Gammaked, Gamunex-C Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified
Grifols Therapeutics LLC
- Approved
- Aug 27, 2003
- 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.
Reference approval
Approval date of the reference Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified product.
23 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
10 yr 11 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.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.