onasemnogene abeparvovec-brve (ITVISMA)
onasemnogene abeparvovec-brve is an FDA-licensed reference biologic from Novartis Gene Therapies, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2025
Reference approved
Reference product
ITVISMA onasemnogene abeparvovec-brve
Novartis Gene Therapies, Inc.
- Approved
- Nov 24, 2025
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for onasemnogene abeparvovec-brve, in chronological order.
Reference approval
Approval date of the reference onasemnogene abeparvovec-brve product.
6 mo ago
Frequently asked questions
Are there biosimilars approved for onasemnogene abeparvovec-brve (ITVISMA)?
No 351(k) biosimilars or interchangeable biosimilars referencing onasemnogene abeparvovec-brve are listed in the FDA Purple Book yet.
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Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.