Coagulation Factor IX (Recombinant), Albumin Fusion Protein (Idelvion)
Coagulation Factor IX (Recombinant), Albumin Fusion Protein is an FDA-licensed reference biologic from CSL Behring Lengnau AG. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2016
Reference approved
Reference product
Idelvion Coagulation Factor IX (Recombinant), Albumin Fusion Protein
CSL Behring Lengnau AG
- Approved
- Mar 04, 2016
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Coagulation Factor IX (Recombinant), Albumin Fusion Protein, in chronological order.
Reference approval
Approval date of the reference Coagulation Factor IX (Recombinant), Albumin Fusion Protein product.
10 yr 5 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
3 yr 4 mo ago
Frequently asked questions
Are there biosimilars approved for Coagulation Factor IX (Recombinant), Albumin Fusion Protein (Idelvion)?
No 351(k) biosimilars or interchangeable biosimilars referencing Coagulation Factor IX (Recombinant), Albumin Fusion Protein are listed in the FDA Purple Book yet.
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