Antihemophilic Factor (Recombinant), Single Chain (Afstyla)
Antihemophilic Factor (Recombinant), Single Chain is an FDA-licensed reference biologic from CSL Behring Lengnau AG. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2017
Reference approved
Reference product
Afstyla Antihemophilic Factor (Recombinant), Single Chain
CSL Behring Lengnau AG
- Approved
- Mar 31, 2017
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Antihemophilic Factor (Recombinant), Single Chain, in chronological order.
Reference approval
Approval date of the reference Antihemophilic Factor (Recombinant), Single Chain product.
9 yr 4 mo ago
Frequently asked questions
Are there biosimilars approved for Antihemophilic Factor (Recombinant), Single Chain (Afstyla)?
No 351(k) biosimilars or interchangeable biosimilars referencing Antihemophilic Factor (Recombinant), Single Chain are listed in the FDA Purple Book yet.
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