Purple Book product · Reference 351(a)

Hizentra

Immune Globulin Subcutaneous (Human), 20% Liquid

351(a)BLA 125350RxLicensed CSL Behring AG

View Immune Globulin Subcutaneous (Human), 20% Liquid family Label PDF Open on FDA Purple Book

Apr 13, 2023

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Hizentra (Immune Globulin Subcutaneous (Human), 20% Liquid) is CSL Behring AG's FDA-licensed reference biologic, approved under a 351(a) BLA in 2023. No biosimilars referencing Hizentra are listed in the Purple Book yet.

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

Key dates

Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Jul 23, 2018
8 yr 1 mo ago
Approval
Approval date of this BLA submission.
Apr 13, 2023
3 yr 4 mo ago
Today

Pharmaceutical detail

Strength

2G/10ML

Dosage form

Injection

Route

Subcutaneous

Presentation

Pre-Filled Syringe

Center

CBER

License number

1766

Product number

006

Submission type

Supplement

Supplement number

614

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.

7 additional BLA records for this product (other strengths or presentations) are in the same reference family.

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

v8Jul 02, 2026
v7Jul 02, 2026
v6Jul 02, 2026
v5Jul 02, 2026
v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026
v1Jul 02, 2026

Frequently asked questions

Does Hizentra have approved biosimilars?

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

What is Hizentra's BLA number?

Hizentra is licensed under BLA 125350, held by CSL Behring AG.

When was Hizentra approved by the FDA?

Hizentra was approved by the FDA on Apr 13, 2023.

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