Purple Book reference family · 351(a) biologic
Antihemophilic factor (recombinant), PEGylated-aucl (Jivi)
Antihemophilic factor (recombinant), PEGylated-aucl is an FDA-licensed reference biologic from Bayer HealthCare LLC.
351(a) biologicBLA 125661 Bayer HealthCare LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2018
Reference product
Originator biologic
351(a)BLA 125661
Jivi Antihemophilic factor (recombinant), PEGylated-aucl
Bayer HealthCare 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 Antihemophilic factor (recombinant), PEGylated-aucl product.
8 yr ago
Antihemophilic factor (recombinant), PEGylated-aucl: 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 Antihemophilic factor (recombinant), PEGylated-aucl.
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