Coagulation Factor IX (Recombinant), GlycoPEGylated (Rebinyn)
Coagulation Factor IX (Recombinant), GlycoPEGylated is an FDA-licensed reference biologic from Novo Nordisk Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2017
Reference approved
Reference product
Rebinyn Coagulation Factor IX (Recombinant), GlycoPEGylated
Novo Nordisk Inc.
- Approved
- May 31, 2017
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Coagulation Factor IX (Recombinant), GlycoPEGylated, in chronological order.
Reference approval
Approval date of the reference Coagulation Factor IX (Recombinant), GlycoPEGylated product.
9 yr 2 mo ago
Frequently asked questions
Are there biosimilars approved for Coagulation Factor IX (Recombinant), GlycoPEGylated (Rebinyn)?
No 351(k) biosimilars or interchangeable biosimilars referencing Coagulation Factor IX (Recombinant), GlycoPEGylated are listed in the FDA Purple Book yet.
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