Antihemophilic Factor (Recombinant), Fc Fusion protein (Eloctate)
Antihemophilic Factor (Recombinant), Fc Fusion protein 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
2014
Reference approved
Reference product
Eloctate Antihemophilic Factor (Recombinant), Fc Fusion protein
Bioverativ Therapeutics, Inc.
- Approved
- Jun 06, 2014
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Antihemophilic Factor (Recombinant), Fc Fusion protein, in chronological order.
Reference approval
Approval date of the reference Antihemophilic Factor (Recombinant), Fc Fusion protein product.
12 yr 4 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
5 yr 2 mo ago
Frequently asked questions
Are there biosimilars approved for Antihemophilic Factor (Recombinant), Fc Fusion protein (Eloctate)?
No 351(k) biosimilars or interchangeable biosimilars referencing Antihemophilic Factor (Recombinant), Fc Fusion protein are listed in the FDA Purple Book yet.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.