Purple Book reference family · 351(a) biologic
Antihemophilic Factor (Recombinant), GlycoPEGylated-exei (Esperoct)
Antihemophilic Factor (Recombinant), GlycoPEGylated-exei is an FDA-licensed reference biologic from Novo Nordisk Inc..
351(a) biologicBLA 125671 Novo Nordisk Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2019
Reference product
Originator biologic
351(a)BLA 125671
Esperoct Antihemophilic Factor (Recombinant), GlycoPEGylated-exei
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 Antihemophilic Factor (Recombinant), GlycoPEGylated-exei product.
7 yr 6 mo ago
Antihemophilic Factor (Recombinant), GlycoPEGylated-exei: 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 Antihemophilic Factor (Recombinant), GlycoPEGylated-exei.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
