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FDA Purple Book · Reference family

Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) (Acthib,Omnihib)

Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) is an FDA-licensed reference biologic from Sanofi Winthrop Industrie. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2000

Reference approved

Reference product

351(a)BLA 103935

Acthib,Omnihib Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)

Sanofi Winthrop Industrie

Approved
Feb 04, 2000
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), in chronological order.

  1. Reference approval

    Approval date of the reference Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) product.

    26 yr 8 mo ago

Frequently asked questions

Are there biosimilars approved for Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) (Acthib,Omnihib)?

No 351(k) biosimilars or interchangeable biosimilars referencing Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) are listed in the FDA Purple Book yet.

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