Purple Book product · Reference 351(a)

tecelra

afamitresgene autoleucel

351(a)BLA 125789RxLicensed USWM CT, LLC

View afamitresgene autoleucel family Label PDF Open on FDA Purple Book

Aug 01, 2024

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

tecelra (afamitresgene autoleucel) is USWM CT, LLC's FDA-licensed reference biologic, approved under a 351(a) BLA in 2024. No biosimilars referencing tecelra are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Aug 01, 1936.

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

Key dates

Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Aug 01, 1931
96 yr 4 mo ago
Reference product exclusivity ends
12-year reference-product exclusivity window per BPCIA §351(k)(7).
Aug 01, 1936
91 yr 3 mo ago
First licensure
Date the BLA was first licensed.
Aug 01, 2024
2 yr ago
Approval
Approval date of this BLA submission.
Aug 01, 2024
2 yr ago
Today

Pharmaceutical detail

Strength

2.68 x 10^9 to 10 x 10^9 CELL/ML

Dosage form

Suspension

Route

Intravenous

Presentation

Bag

Center

CBER

License number

2416

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 tecelra have approved biosimilars?

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

When does tecelra lose reference-product exclusivity?

tecelra's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Aug 01, 1936.

What is tecelra's BLA number?

tecelra is licensed under BLA 125789, held by USWM CT, LLC.

When was tecelra approved by the FDA?

tecelra was first licensed by the FDA on Aug 01, 2024.

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