Coagulation Factor IX (Recombinant), Fc Fusion Protein (Alprolix)
Coagulation Factor IX (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
2016
Reference approved
Reference product
Alprolix Coagulation Factor IX (Recombinant), Fc Fusion Protein
Bioverativ Therapeutics, Inc.
- Approved
- Feb 18, 2016
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Coagulation Factor IX (Recombinant), Fc Fusion Protein, in chronological order.
Reference approval
Approval date of the reference Coagulation Factor IX (Recombinant), Fc Fusion Protein product.
10 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
5 yr 5 mo ago
Frequently asked questions
Are there biosimilars approved for Coagulation Factor IX (Recombinant), Fc Fusion Protein (Alprolix)?
No 351(k) biosimilars or interchangeable biosimilars referencing Coagulation Factor IX (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.