Purple Book reference family · 351(a) biologic
Antihemophilic Factor/von Willebrand Factor Complex (Human) (Alphanate)
Antihemophilic Factor/von Willebrand Factor Complex (Human) is an FDA-licensed reference biologic from Grifols Biologicals LLC.
351(a) biologicBLA 102475 Grifols Biologicals LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1978
Reference product
Originator biologic
351(a)BLA 102475
Alphanate Antihemophilic Factor/von Willebrand Factor Complex (Human)
Grifols Biologicals 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/von Willebrand Factor Complex (Human) product.
48 yr 10 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
12 yr 10 mo ago
Antihemophilic Factor/von Willebrand Factor Complex (Human): 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/von Willebrand Factor Complex (Human).
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
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