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FDA Purple Book · Reference family

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 exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2013

Reference approved

Reference product

351(a)BLA 125462

Bat Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)

Emergent BioSolutions Canada Inc.

Approved
Mar 22, 2013
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine), in chronological order.

  1. Reference approval

    Approval date of the reference Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) product.

    13 yr 5 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    6 yr 3 mo ago

Frequently asked questions

Are there biosimilars approved for Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) (Bat)?

No 351(k) biosimilars or interchangeable biosimilars referencing Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) are listed in the FDA Purple Book yet.

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