Purple Book reference family · 351(a) biologic
Coagulation Factor IX (Recombinant), GlycoPEGylated (Rebinyn)
Coagulation Factor IX (Recombinant), GlycoPEGylated is an FDA-licensed reference biologic from Novo Nordisk Inc..
351(a) biologicBLA 125611 Novo Nordisk Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2017
Reference product
Originator biologic
351(a)BLA 125611
Rebinyn Coagulation Factor IX (Recombinant), GlycoPEGylated
Novo Nordisk Inc.
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), GlycoPEGylated product.
9 yr 3 mo ago
Coagulation Factor IX (Recombinant), GlycoPEGylated: 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), GlycoPEGylated.
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