Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) (Bat)
Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) is an FDA-licensed reference biologic from Emergent BioSolutions Canada Inc..
Reference product
Bat Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)
Emergent BioSolutions Canada Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Reference approval
Approval date of the reference Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) product.
13 yr 8 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
6 yr 7 mo ago
Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine): 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 Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine).
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 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.
