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FDA Purple Book · Reference family

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Adacel)

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed is an FDA-licensed reference biologic from Sanofi Pasteur Limited. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2005

Reference approved

Reference product

351(a)BLA 125111

Adacel Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed

Sanofi Pasteur Limited

Approved
Jun 10, 2005
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed, in chronological order.

  1. Reference approval

    Approval date of the reference Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed product.

    21 yr 3 mo ago

Frequently asked questions

Are there biosimilars approved for Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Adacel)?

No 351(k) biosimilars or interchangeable biosimilars referencing Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed are listed in the FDA Purple Book yet.

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