Purple Book product · Reference 351(a)

Hemgenix

etranacogene dezaparvovec-drlb

351(a)BLA 125772RxLicensed CSL Behring LLC

View etranacogene dezaparvovec-drlb family Label PDF Open on FDA Purple Book

Nov 22, 2022

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Hemgenix (etranacogene dezaparvovec-drlb) is CSL Behring LLC's FDA-licensed reference biologic, approved under a 351(a) BLA in 2022. No biosimilars referencing Hemgenix are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Nov 22, 1934.

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).
Nov 22, 1934
93 yr ago
First licensure
Date the BLA was first licensed.
Nov 22, 2022
3 yr 8 mo ago
Approval
Approval date of this BLA submission.
Nov 22, 2022
3 yr 8 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Nov 22, 2029
in 3 yr 5 mo

Pharmaceutical detail

Strength

1X10E13GENOME COPIES/ML

Dosage form

Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CBER

License number

1767

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 Hemgenix have approved biosimilars?

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

When does Hemgenix lose reference-product exclusivity?

Hemgenix's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Nov 22, 1934.

What is Hemgenix's BLA number?

Hemgenix is licensed under BLA 125772, held by CSL Behring LLC.

When was Hemgenix approved by the FDA?

Hemgenix was first licensed by the FDA on Nov 22, 2022.

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