Purple Book reference family · 351(a) biologic
onasemnogene abeparvovec-brve (ITVISMA)
onasemnogene abeparvovec-brve is an FDA-licensed reference biologic from Novartis Gene Therapies, Inc..
351(a) biologicBLA 125856 Novartis Gene Therapies, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2025
Reference product
Originator biologic
351(a)BLA 125856
ITVISMA onasemnogene abeparvovec-brve
Novartis Gene Therapies, 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 onasemnogene abeparvovec-brve product.
8 mo ago
onasemnogene abeparvovec-brve: 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 onasemnogene abeparvovec-brve.
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