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FDA Purple Book · Reference family

Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (Pedvaxhib)

Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) is an FDA-licensed reference biologic from Merck Sharp & Dohme LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

1989

Reference approved

Reference product

351(a)BLA 103237

Pedvaxhib Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)

Merck Sharp & Dohme LLC

Approved
Dec 20, 1989
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

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

  1. Reference approval

    Approval date of the reference Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) product.

    37 yr ago

Frequently asked questions

Are there biosimilars approved for Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (Pedvaxhib)?

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

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