Purple Book reference family · 351(a) biologic
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..
351(a) biologicBLA 125444 Bioverativ Therapeutics, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2016
Reference product
Originator biologic
351(a)BLA 125444
Alprolix Coagulation Factor IX (Recombinant), Fc Fusion Protein
Bioverativ Therapeutics, Inc.
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 Coagulation Factor IX (Recombinant), Fc Fusion Protein product.
10 yr 9 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
5 yr 7 mo ago
Coagulation Factor IX (Recombinant), Fc Fusion Protein: 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 Coagulation Factor IX (Recombinant), Fc Fusion Protein.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
