Botulism Immune Globulin Intravenous (Human) (BabyBig)
Botulism Immune Globulin Intravenous (Human) is an FDA-licensed reference biologic from California Department of Public Health (CDPH). 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
BabyBig Botulism Immune Globulin Intravenous (Human)
California Department of Public Health (CDPH)
- Approved
- Oct 23, 2003
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Botulism Immune Globulin Intravenous (Human), in chronological order.
Reference approval
Approval date of the reference Botulism Immune Globulin Intravenous (Human) product.
22 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
15 yr 10 mo ago
Frequently asked questions
Are there biosimilars approved for Botulism Immune Globulin Intravenous (Human) (BabyBig)?
No 351(k) biosimilars or interchangeable biosimilars referencing Botulism Immune Globulin Intravenous (Human) are listed in the FDA Purple Book yet.
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Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.