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FDA Purple Book · Reference family

Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed (Daptacel)

Diphtheria & Tetanus Toxoids & 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

2002

Reference approved

Reference product

351(a)BLA 103666

Daptacel Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed

Sanofi Pasteur Limited

Approved
May 14, 2002
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

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

  1. Reference approval

    Approval date of the reference Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed product.

    24 yr 5 mo ago

Frequently asked questions

Are there biosimilars approved for Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed (Daptacel)?

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

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