Purple Book reference family · 351(a) biologic
ropeginterferon alfa-2b-njft (Besremi)
ropeginterferon alfa-2b-njft is an FDA-licensed reference biologic from PharmaEssentia Corporation.
351(a) biologicBLA 761166 PharmaEssentia Corporation
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2021
Reference product
Originator biologic
351(a)BLA 761166
Besremi ropeginterferon alfa-2b-njft
PharmaEssentia Corporation
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference ropeginterferon alfa-2b-njft product.
4 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 2 yr 2 mo
ropeginterferon alfa-2b-njft: 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 ropeginterferon alfa-2b-njft.
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- 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.
