Purple Book reference family · 351(a) biologic
Coagulation Factor IX (Recombinant) (Benefix)
Coagulation Factor IX (Recombinant) is an FDA-licensed reference biologic from Wyeth Pharmaceuticals LLC.
351(a) biologicBLA 103677 Wyeth Pharmaceuticals LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1997
Reference product
Originator biologic
351(a)BLA 103677
Benefix Coagulation Factor IX (Recombinant)
Wyeth Pharmaceuticals 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 Coagulation Factor IX (Recombinant) product.
30 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
22 yr 11 mo ago
Coagulation Factor IX (Recombinant): 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).
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