Cytomegalovirus Immune Globulin Intravenous (Human) (Cytogam)
Cytomegalovirus Immune Globulin Intravenous (Human) is an FDA-licensed reference biologic from Kamada Ltd.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1990
Reference approved
Reference product
Cytogam Cytomegalovirus Immune Globulin Intravenous (Human)
Kamada Ltd.
- Approved
- Apr 17, 1990
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Cytomegalovirus Immune Globulin Intravenous (Human), in chronological order.
Reference approval
Approval date of the reference Cytomegalovirus Immune Globulin Intravenous (Human) product.
36 yr 8 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
21 yr ago
Frequently asked questions
Are there biosimilars approved for Cytomegalovirus Immune Globulin Intravenous (Human) (Cytogam)?
No 351(k) biosimilars or interchangeable biosimilars referencing Cytomegalovirus Immune Globulin Intravenous (Human) are listed in the FDA Purple Book yet.
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