Purple Book reference family · 351(a) biologic
Anthrax Immune Globulin Intravenous (Human) (Anthrasil)
Anthrax Immune Globulin Intravenous (Human) is an FDA-licensed reference biologic from Emergent BioSolutions Canada Inc..
351(a) biologicBLA 125562 Emergent BioSolutions Canada Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2015
Reference product
Originator biologic
351(a)BLA 125562
Anthrasil Anthrax Immune Globulin Intravenous (Human)
Emergent BioSolutions Canada Inc.
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 Anthrax Immune Globulin Intravenous (Human) product.
11 yr 8 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
4 yr 7 mo ago
Anthrax 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 Anthrax Immune Globulin Intravenous (Human).
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- 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.
