Purple Book product · Reference 351(a)

Carvykti

ciltacabtagene autoleucel

351(a)BLA 125746RxLicensed Janssen Biotech, Inc.

View ciltacabtagene autoleucel family Label PDF Open on FDA Purple Book

Feb 28, 2022

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Carvykti (ciltacabtagene autoleucel) is Janssen Biotech, Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2022. No biosimilars referencing Carvykti are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Feb 28, 1934.

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

Key dates

Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Apr 05, 1931
96 yr 8 mo ago
Reference product exclusivity ends
12-year reference-product exclusivity window per BPCIA §351(k)(7).
Feb 28, 1934
93 yr 9 mo ago
First licensure
Date the BLA was first licensed.
Feb 28, 2022
4 yr 5 mo ago
Approval
Approval date of this BLA submission.
Feb 28, 2022
4 yr 5 mo ago
Today

Pharmaceutical detail

Strength

0.5 to 1.0x10^6 chimeric antigen receptor (CAR)-positive viable T cells per kg of body weight, with a maximum dose of 1x10^8 CAR-positive viable T cells in one infusion

Dosage form

For Injection

Route

Intravenous

Presentation

Bag

Center

CBER

License number

1864

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 Carvykti have approved biosimilars?

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

When does Carvykti lose reference-product exclusivity?

Carvykti's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Feb 28, 1934.

What is Carvykti's BLA number?

Carvykti is licensed under BLA 125746, held by Janssen Biotech, Inc..

When was Carvykti approved by the FDA?

Carvykti was first licensed by the FDA on Feb 28, 2022.

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