Purple Book reference family · 351(a) biologic
Anthrax Vaccine Adsorbed (Biothrax)
Anthrax Vaccine Adsorbed is an FDA-licensed reference biologic from Emergent BioDefense Operations Lansing LLC.
351(a) biologicBLA 103821 Emergent BioDefense Operations Lansing LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1998
Reference product
Originator biologic
351(a)BLA 103821
Biothrax Anthrax Vaccine Adsorbed
Emergent BioDefense Operations Lansing LLC
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 Vaccine Adsorbed product.
28 yr 3 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
3 yr 11 mo ago
Anthrax Vaccine Adsorbed: 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 Vaccine Adsorbed.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
