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Purple Book reference family · 351(a) biologic

Botulism Antitoxin Bivalent (Equine) Types A and B.

Botulism Antitoxin Bivalent (Equine) Types A and B. is an FDA-licensed reference biologic from Sanofi Vaccines Canada Ltd..

351(a) biologicBLA 103937 Sanofi Vaccines Canada Ltd.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2000

Reference product

Originator biologic
351(a)BLA 103937

Not listed Botulism Antitoxin Bivalent (Equine) Types A and B.

Sanofi Vaccines Canada Ltd.

View full reference-product record
Approved
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Protection horizon
  1. Reference approval

    Approval date of the reference Botulism Antitoxin Bivalent (Equine) Types A and B. product.

    26 yr 10 mo ago

Botulism Antitoxin Bivalent (Equine) Types A and B.: 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 Bivalent (Equine) Types A and B..

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