Purple Book product · Reference 351(a)

Aucatzyl

Obecabtagene autoleucel

351(a)BLA 125813RxLicensed Autolus, Inc.

View Obecabtagene autoleucel family Label PDF Open on FDA Purple Book

Nov 08, 2024

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Aucatzyl (Obecabtagene autoleucel) is Autolus, Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2024. No biosimilars referencing Aucatzyl are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Nov 08, 1936.

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

Key dates

Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Nov 08, 1931
96 yr 1 mo ago
Reference product exclusivity ends
12-year reference-product exclusivity window per BPCIA §351(k)(7).
Nov 08, 1936
91 yr ago
First licensure
Date the BLA was first licensed.
Nov 08, 2024
1 yr 9 mo ago
Approval
Approval date of this BLA submission.
Nov 08, 2024
1 yr 9 mo ago
Today

Pharmaceutical detail

Strength

410 Ã— 10^6CAR+ T CELLS TOTAL; DELIVERED AS A SPLIT DOSE IN 3-5 BAGS ON DAY 1 & 10

Dosage form

Suspension

Route

Intravenous

Presentation

Bag

Center

CBER

License number

2339

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 Aucatzyl have approved biosimilars?

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

When does Aucatzyl lose reference-product exclusivity?

Aucatzyl's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Nov 08, 1936.

What is Aucatzyl's BLA number?

Aucatzyl is licensed under BLA 125813, held by Autolus, Inc..

When was Aucatzyl approved by the FDA?

Aucatzyl was first licensed by the FDA on Nov 08, 2024.

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