FDA Purple Book · Reference family
Factor IX Complex (Profilnine, Profilnine Hp, Profilnine Ht, Profilnine Sd)
Factor IX Complex is an FDA-licensed reference biologic from Grifols Biologicals LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1981
Reference approved
Reference product
351(a)BLA 102476
Profilnine, Profilnine Hp, Profilnine Ht, Profilnine Sd Factor IX Complex
Grifols Biologicals LLC
- Approved
- Jul 20, 1981
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Factor IX Complex, in chronological order.
Reference approval
Approval date of the reference Factor IX Complex product.
45 yr 6 mo ago
Frequently asked questions
Are there biosimilars approved for Factor IX Complex (Profilnine, Profilnine Hp, Profilnine Ht, Profilnine Sd)?
No 351(k) biosimilars or interchangeable biosimilars referencing Factor IX Complex are listed in the FDA Purple Book yet.
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