Coagulation Factor IX (Recombinant) (Benefix)
Coagulation Factor IX (Recombinant) is an FDA-licensed reference biologic from Wyeth Pharmaceuticals LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1997
Reference approved
Reference product
Benefix Coagulation Factor IX (Recombinant)
Wyeth Pharmaceuticals LLC
- Approved
- Feb 11, 1997
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Coagulation Factor IX (Recombinant), in chronological order.
Reference approval
Approval date of the reference Coagulation Factor IX (Recombinant) product.
29 yr 9 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
22 yr 8 mo ago
Frequently asked questions
Are there biosimilars approved for Coagulation Factor IX (Recombinant) (Benefix)?
No 351(k) biosimilars or interchangeable biosimilars referencing Coagulation Factor IX (Recombinant) are listed in the FDA Purple Book yet.
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