Antihemophilic Factor (Recombinant), GlycoPEGylated-exei (Esperoct)
Antihemophilic Factor (Recombinant), GlycoPEGylated-exei 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
2019
Reference approved
Reference product
Esperoct Antihemophilic Factor (Recombinant), GlycoPEGylated-exei
Novo Nordisk Inc.
- Approved
- Feb 19, 2019
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Antihemophilic Factor (Recombinant), GlycoPEGylated-exei, in chronological order.
Reference approval
Approval date of the reference Antihemophilic Factor (Recombinant), GlycoPEGylated-exei product.
7 yr 5 mo ago
Frequently asked questions
Are there biosimilars approved for Antihemophilic Factor (Recombinant), GlycoPEGylated-exei (Esperoct)?
No 351(k) biosimilars or interchangeable biosimilars referencing Antihemophilic Factor (Recombinant), GlycoPEGylated-exei are listed in the FDA Purple Book yet.
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