antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl (ALTUVIIIO)
antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl is an FDA-licensed reference biologic from Bioverativ Therapeutics, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2023
Reference approved
Reference product
ALTUVIIIO antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl
Bioverativ Therapeutics, Inc.
- Approved
- Feb 22, 2023
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl, in chronological order.
Reference approval
Approval date of the reference antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl product.
3 yr 4 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 3 yr 9 mo
Frequently asked questions
Are there biosimilars approved for antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl (ALTUVIIIO)?
No 351(k) biosimilars or interchangeable biosimilars referencing antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl are listed in the FDA Purple Book yet.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.