Purple Book product · Reference 351(a)

Zynteglo

betibeglogene autotemcel

351(a)BLA 125717RxLicensed Genetix Biotherapeutics Inc.

View betibeglogene autotemcel family Label PDF Open on FDA Purple Book

Aug 17, 2022

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Zynteglo (betibeglogene autotemcel) is Genetix Biotherapeutics Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2022. No biosimilars referencing Zynteglo are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Aug 17, 1934.

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).
Aug 17, 1934
93 yr 3 mo ago
First licensure
Date the BLA was first licensed.
Aug 17, 2022
4 yr ago
Approval
Approval date of this BLA submission.
Aug 17, 2022
4 yr ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Aug 17, 2029
in 3 yr 2 mo

Pharmaceutical detail

Strength

1.7-20 X 10^6CELL/ML

Dosage form

For Injection

Route

Intravenous

Presentation

Bag

Center

CBER

License number

2425

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
monthly-downloadMonthly download · Jul 02, 2026

Change history

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

Frequently asked questions

Does Zynteglo have approved biosimilars?

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

When does Zynteglo lose reference-product exclusivity?

Zynteglo's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Aug 17, 1934.

What is Zynteglo's BLA number?

Zynteglo is licensed under BLA 125717, held by Genetix Biotherapeutics Inc..

When was Zynteglo approved by the FDA?

Zynteglo was first licensed by the FDA on Aug 17, 2022.

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