Purple Book reference family · 351(a) biologic
Antihemophilic Factor (Recombinant), Single Chain (Afstyla)
Antihemophilic Factor (Recombinant), Single Chain is an FDA-licensed reference biologic from CSL Behring Lengnau AG.
351(a) biologicBLA 125591 CSL Behring Lengnau AG
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2017
Reference product
Originator biologic
351(a)BLA 125591
Afstyla Antihemophilic Factor (Recombinant), Single Chain
CSL Behring Lengnau AG
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), Single Chain product.
9 yr 5 mo ago
Antihemophilic Factor (Recombinant), Single Chain: 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), Single Chain.
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