Purple Book product · Reference 351(a)

Zolgensma

onasemnogene abeparvovec-xioi

351(a)BLA 125694RxLicensed Novartis Gene Therapies, Inc.

View onasemnogene abeparvovec-xioi family Label PDF Open on FDA Purple Book

May 24, 2019

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Zolgensma (onasemnogene abeparvovec-xioi) is Novartis Gene Therapies, Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2019. No biosimilars referencing Zolgensma are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Nov 24, 1931.

Sourced from the FDA Purple Book · verified Jul 02, 2026

Key dates

Reference product exclusivity ends
12-year reference-product exclusivity window per BPCIA §351(k)(7).
Nov 24, 1931
96 yr ago
First licensure
Date the BLA was first licensed.
May 24, 2019
7 yr 3 mo ago
Approval
Approval date of this BLA submission.
May 24, 2019
7 yr 3 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Nov 24, 2026
in 4 mo

Pharmaceutical detail

Strength

2x10^13VG/ML

Dosage form

Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CBER

License number

2250

Product number

001

Submission type

Original

Supplement number

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.

Patent list

No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.

Source provenance

Source kind · Advanced Search

Checked Jul 02, 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
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Change history

v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

Does Zolgensma have approved biosimilars?

No 351(k) biosimilars or interchangeable biosimilars referencing Zolgensma are listed in the FDA Purple Book yet.

When does Zolgensma lose reference-product exclusivity?

Zolgensma's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Nov 24, 1931.

What is Zolgensma's BLA number?

Zolgensma is licensed under BLA 125694, held by Novartis Gene Therapies, Inc..

When was Zolgensma approved by the FDA?

Zolgensma was first licensed by the FDA on May 24, 2019.

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