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FDA Purple Book · Reference family

Anthrax Vaccine Adsorbed (Biothrax)

Anthrax Vaccine Adsorbed is an FDA-licensed reference biologic from Emergent BioDefense Operations Lansing LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

1998

Reference approved

Reference product

351(a)BLA 103821

Biothrax Anthrax Vaccine Adsorbed

Emergent BioDefense Operations Lansing LLC

Approved
Nov 12, 1998
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Anthrax Vaccine Adsorbed, in chronological order.

  1. Reference approval

    Approval date of the reference Anthrax Vaccine Adsorbed product.

    27 yr 11 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    3 yr 7 mo ago

Frequently asked questions

Are there biosimilars approved for Anthrax Vaccine Adsorbed (Biothrax)?

No 351(k) biosimilars or interchangeable biosimilars referencing Anthrax Vaccine Adsorbed are listed in the FDA Purple Book yet.

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