Purple Book reference family · 351(a) biologic
Factor IX Complex (Profilnine, Profilnine Hp, Profilnine Ht, Profilnine Sd)
Factor IX Complex is an FDA-licensed reference biologic from Grifols Biologicals LLC.
351(a) biologicBLA 102476 Grifols Biologicals LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1981
Reference product
Originator biologic
351(a)BLA 102476
Profilnine, Profilnine Hp, Profilnine Ht, Profilnine Sd Factor IX Complex
Grifols Biologicals LLC
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 Factor IX Complex product.
45 yr 8 mo ago
Factor IX Complex: 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 Factor IX Complex.
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