onasemnogene abeparvovec-xioi (Zolgensma)
onasemnogene abeparvovec-xioi 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
2019
Reference approved
Reference product
Zolgensma onasemnogene abeparvovec-xioi
Novartis Gene Therapies, Inc.
- Approved
- May 24, 2019
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for onasemnogene abeparvovec-xioi, in chronological order.
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
96 yr ago
First licensure
Date onasemnogene abeparvovec-xioi was first licensed by the FDA.
7 yr 3 mo ago
Reference approval
Approval date of the reference onasemnogene abeparvovec-xioi product.
7 yr 3 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 4 mo
Frequently asked questions
Are there biosimilars approved for onasemnogene abeparvovec-xioi (Zolgensma)?
No 351(k) biosimilars or interchangeable biosimilars referencing onasemnogene abeparvovec-xioi are listed in the FDA Purple Book yet.
When does onasemnogene abeparvovec-xioi (Zolgensma) lose reference-product exclusivity?
onasemnogene abeparvovec-xioi's 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending November 24, 1931.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.