Purple Book product · Reference 351(a)

encelto

revakinagene taroretcel-lwey

351(a)BLA 125798RxLicensed Neurotech Pharmaceuticals Inc.

View revakinagene taroretcel-lwey family Label PDF Open on FDA Purple Book

Mar 05, 2025

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

encelto (revakinagene taroretcel-lwey) is Neurotech Pharmaceuticals Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2025. No biosimilars referencing encelto are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Mar 05, 1937.

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).
Mar 05, 1937
90 yr 8 mo ago
First licensure
Date the BLA was first licensed.
Mar 05, 2025
1 yr 5 mo ago
Approval
Approval date of this BLA submission.
Mar 05, 2025
1 yr 5 mo ago
Today

Pharmaceutical detail

Strength

200,000-440,000CELLS/IMPLANT

Dosage form

Implant

Route

Implantation

Presentation

Capsule

Center

CBER

License number

2321

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 encelto have approved biosimilars?

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

When does encelto lose reference-product exclusivity?

encelto's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Mar 05, 1937.

What is encelto's BLA number?

encelto is licensed under BLA 125798, held by Neurotech Pharmaceuticals Inc..

When was encelto approved by the FDA?

encelto was first licensed by the FDA on Mar 05, 2025.

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