Purple Book reference family · 351(a) biologic
Coagulation Factor IX (Human) (Alphanine, Alphanine Hp, Alphanine Sd)
Coagulation Factor IX (Human) is an FDA-licensed reference biologic from Grifols Biologicals LLC.
351(a) biologicBLA 103249 Grifols Biologicals LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1990
Reference product
Originator biologic
351(a)BLA 103249
Alphanine, Alphanine Hp, Alphanine Sd Coagulation Factor IX (Human)
Grifols Biologicals LLC
View full reference-product record- Approved
- Marketing
- Disc
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Coagulation Factor IX (Human) product.
36 yr 3 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 72 yr 4 mo
Coagulation Factor IX (Human): 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 (Human).
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
