Purple Book reference family · 351(a) biologic
Cytomegalovirus Immune Globulin Intravenous (Human) (Cytogam)
Cytomegalovirus Immune Globulin Intravenous (Human) is an FDA-licensed reference biologic from Kamada Ltd..
351(a) biologicBLA 103189 Kamada Ltd.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1990
Reference product
Originator biologic
351(a)BLA 103189
Cytogam Cytomegalovirus Immune Globulin Intravenous (Human)
Kamada Ltd.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Cytomegalovirus Immune Globulin Intravenous (Human) product.
37 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
21 yr 3 mo ago
Cytomegalovirus Immune Globulin Intravenous (Human): 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 Cytomegalovirus Immune Globulin Intravenous (Human).
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