Purple Book product · Reference 351(a)

BEQVEZ

fidanacogene elaparvovec-dzkt

351(a)BLA 125786DiscVoluntarily Revoked Pfizer Inc.

View fidanacogene elaparvovec-dzkt family Open on FDA Purple Book

Apr 25, 2024

Approved

Reference 351(a)

License type

Disc

Marketing

None

Listed patents

BEQVEZ (fidanacogene elaparvovec-dzkt) is Pfizer Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2024. No biosimilars referencing BEQVEZ are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Apr 25, 1936.

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

Key dates

Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Apr 25, 1931
96 yr 7 mo ago
Reference product exclusivity ends
12-year reference-product exclusivity window per BPCIA §351(k)(7).
Apr 25, 1936
91 yr 7 mo ago
First licensure
Date the BLA was first licensed.
Apr 25, 2024
2 yr 3 mo ago
Approval
Approval date of this BLA submission.
Apr 25, 2024
2 yr 3 mo ago
Today

Pharmaceutical detail

Strength

1x E13 VG/ML

Dosage form

Suspension

Route

Intravenous

Presentation

Single-Dose Vial

Center

CBER

License number

2001

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 BEQVEZ have approved biosimilars?

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

When does BEQVEZ lose reference-product exclusivity?

BEQVEZ's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Apr 25, 1936.

What is BEQVEZ's BLA number?

BEQVEZ is licensed under BLA 125786, held by Pfizer Inc..

When was BEQVEZ approved by the FDA?

BEQVEZ was first licensed by the FDA on Apr 25, 2024.

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