Purple Book product · Reference 351(a)

AMTAGVI

Lifileucel

351(a)BLA 125773RxLicensed Iovance Biotherapeutics, Inc.

View Lifileucel family Label PDF Open on FDA Purple Book

Feb 16, 2024

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

AMTAGVI (Lifileucel) is Iovance Biotherapeutics, Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2024. No biosimilars referencing AMTAGVI are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Feb 16, 1936.

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

Key dates

Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Feb 16, 1931
96 yr 10 mo ago
Reference product exclusivity ends
12-year reference-product exclusivity window per BPCIA §351(k)(7).
Feb 16, 1936
91 yr 9 mo ago
First licensure
Date the BLA was first licensed.
Feb 16, 2024
2 yr 5 mo ago
Approval
Approval date of this BLA submission.
Feb 16, 2024
2 yr 5 mo ago
Today

Pharmaceutical detail

Strength

7.5x10^9 to 72x10^9Cells

Dosage form

Suspension

Route

Intravenous

Presentation

Bag

Center

CBER

License number

2298

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 AMTAGVI have approved biosimilars?

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

When does AMTAGVI lose reference-product exclusivity?

AMTAGVI's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Feb 16, 1936.

What is AMTAGVI's BLA number?

AMTAGVI is licensed under BLA 125773, held by Iovance Biotherapeutics, Inc..

When was AMTAGVI approved by the FDA?

AMTAGVI was first licensed by the FDA on Feb 16, 2024.

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