Purple Book reference family · 351(a) biologic
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.
351(a) biologicBLA 103237 Merck Sharp & Dohme LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1989
Reference product
Originator biologic
351(a)BLA 103237
Pedvaxhib Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)
Merck Sharp & Dohme LLC
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) product.
37 yr 2 mo ago
Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate): 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 Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate).
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.

