Purple Book reference family · 351(a) biologic
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.
351(a) biologicBLA 103935 Sanofi Winthrop Industrie
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2000
Reference product
Originator biologic
351(a)BLA 103935
Acthib,Omnihib Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
Sanofi Winthrop Industrie
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 (Tetanus Toxoid Conjugate) product.
26 yr 10 mo ago
Haemophilus b Conjugate Vaccine (Tetanus Toxoid 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 (Tetanus Toxoid Conjugate).
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