What is Hizentra in the FDA Purple Book?

Hizentra, BLA 125350, is listed as a 351(a) biologic with 8 exact FDA presentation rows. The page preserves the BLA-level regulatory role and does not substitute clinical, inventory, or legal conclusions for the source record.

Who is responsible for BLA 125350?

Hizentra, BLA 125350, lists CSL Behring AG as the BLA applicant. The applicant field identifies responsibility for the application; it does not, by itself, prove that the organization physically manufactures, labels, distributes, or currently sells every presentation.

What presentations are listed for Hizentra?

Hizentra, BLA 125350, has 8 exact FDA presentation rows consolidated on this page. Strength, dosage form, route, product number, licensure, and marketing fields remain attached to their own row rather than being merged into disconnected lists.

What is Hizentra's reference-product relationship?

Hizentra, BLA 125350, does not state a reference product in the loaded FDA row. That bounded result is not proof about future eligibility or relationships outside this snapshot. This answer is limited to the current FDA Purple Book record and its exact BLA-level fields.

Is Hizentra interchangeable?

Hizentra, BLA 125350, is not presented as an interchangeable product. Interchangeability is an FDA designation attached to an individual 351(k) follow-on, not a property inferred from this 351(a) BLA or its family.

When was Hizentra licensed by FDA?

Hizentra, BLA 125350, has a listed FDA approval date of Apr 13, 2023. The date is reproduced from this exact Purple Book BLA record and is not a statement about commercial launch or current availability.

Does this page summarize Hizentra's FDA label?

Hizentra, BLA 125350, No exact-BLA label candidate is stored for this record. Approved uses, dosing, and warnings are intentionally unavailable and queued for exact-source research. Therefore the page does not publish product-specific approved uses, dosing, boxed warnings, or safety claims from a reference product or same-ingredient document.

What patent information is published for Hizentra?

Hizentra, BLA 125350, has no published patent rows in the loaded Purple Book patent data. That is a bounded source result, not proof that no relevant patent rights exist or a freedom-to-operate conclusion.

What exclusivity information is listed for Hizentra?

Hizentra, BLA 125350, has 1 populated Purple Book exclusivity field, with the latest listed date on Jul 23, 2018. Regulatory exclusivity dates are not patent opinions, inventory signals, or guaranteed market-entry dates.

FDA Purple Book product · 351(a) biologic

Hizentra

Immune Globulin Subcutaneous (Human), 20% Liquid

Hizentra, BLA 125350, is listed in the FDA Purple Book as a 351(a) biologic. This page consolidates 8 exact FDA presentation rows, and no exact reference-product relationship is asserted. It separates the BLA applicant from any unverified manufacturer and does not infer clinical labeling, pharmacy substitution, commercial availability, or patent conclusions.

351(a)BLA 125350 8 presentationsRxLicensed CSL Behring AG

Approved

Apr 13, 2023

License type

351(a)

Marketing

Listed patents

Hizentra (Immune Globulin Subcutaneous (Human), 20% Liquid) is CSL Behring AG's FDA-licensed 351(a) biologic under BLA 125350, approved in 2023. No 351(k) product in the loaded Purple Book family data explicitly references Hizentra; that bounded result is not a claim about future reference-product eligibility.

Sourced from the FDA Purple Book · verified Aug 11, 2026

What this Purple Book record establishes

Regulatory interpretation

BLA number

125350

Regulatory role

351(a) biologic

Applicant

CSL Behring AG

Applicant is not automatically the physical manufacturer.

Presentations

Exact FDA presentation rows under this BLA.

Approval

Apr 13, 2023

Reference product

Not stated

Hizentra is an FDA-licensed 351(a) biologic.

No 351(k) product in the loaded Purple Book family data explicitly references Hizentra.

Substitution boundary

The absence of a linked 351(k) record is a bounded database result, not proof that the product can never serve as a reference product.

Key dates

Licensure & exclusivity

Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Jul 23, 2018
8 yr 3 mo ago
Approval
Approval date of this BLA submission.
Apr 13, 2023
3 yr 6 mo ago
Today

Strengths & presentations

8 FDA presentation rows · BLA 125350

Strength

2G/10ML

Dosage form

Injection

Route

Subcutaneous

Presentation

Single-Dose Vial

Center

CBER

License number

1766

Product number

001

Submission type

Original

Supplement number

Change type

Not listed

Exact presentation matrix

One row per FDA presentation under this exact BLA. Missing cells remain unavailable rather than being borrowed from another product.

Exact FDA Purple Book presentation rows for this BLA
Product	Strength	Dosage form	Route	Presentation	Licensure	Marketing
001	2G/10ML	Injection	Subcutaneous	Single-Dose Vial	Licensed	Rx
002	1G/5ML	Injection	Subcutaneous	Single-Dose Vial	Licensed	Rx
003	10G/50ML	Injection	Subcutaneous	Single-Dose Vial	Licensed	Rx
004	4G/20ML	Injection	Subcutaneous	Single-Dose Vial	Licensed	Rx
005	1G/5ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx
006	2G/10ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx
007	4G/20ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx
008	10G/50ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx

Exact-source evidence coverage

Labeling & approval review

Current product label

Exact-source research required

No exact-BLA label candidate is stored for this record. Approved uses, dosing, and warnings are intentionally unavailable and queued for exact-source research.

FDA approval evidence

Not applicable to 351(a)

A biosimilar totality-of-evidence summary is not applicable to this 351(a) record. Product-specific clinical content still requires an exact-BLA label or review source.

Human review pending

Automated BLA-level interpretation has not been marked human-reviewed. The research queue contains 1 exact-source task. Labeling and approval-review claims stay unavailable until their own match gate passes.

Reference product family

Biosimilars & interchangeables

View full family

The current record does not expose a reference-product name or an exact linked 351(k) family for Hizentra.

No reference product is stated in this exact Purple Book row. This is a bounded snapshot result, not proof of real-world absence.

Published patents

BPCIA 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.

Practical characteristics and limits

Source-bounded interpretation

Presentation coverage

8 exact FDA presentation rows are consolidated under this BLA rather than split across duplicate pages.

Administration fields

The loaded rows list Subcutaneous and Injection; these are regulatory presentation fields, not dosing instructions.

Applicant boundary

CSL Behring AG is the listed BLA applicant. The page does not relabel the applicant as manufacturer, labeler, distributor, or commercial supplier without an exact product-specific source.

Regulatory comparison

Hizentra is an FDA-licensed 351(a) biologic. Family comparisons preserve each BLA's own designation and do not use Orange Book therapeutic-equivalence terminology.

Source provenance

FDA Purple Book data

Source kind · Monthly download

Checked Aug 11, 2026

FDA release · June 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
monthly-downloadMonthly download · Jul 02, 2026

What this record does not establish

Purple Book marketing status is a regulatory field, not real-time commercial inventory or launch status.
The listed applicant or BLA holder is not automatically the product’s physical manufacturer, labeler, or distributor.
Biosimilar status and interchangeability are distinct FDA designations; neither is a therapeutic-equivalence code from the Orange Book.
A missing patent or exclusivity row is not proof that no relevant rights exist, and listed patent information is not a freedom-to-operate opinion.
Approved uses, dosing, warnings, and clinical evidence require the exact current product label or approval package and are not inferred from the reference product.

Change history

Record versions

v10Aug 11, 2026
v9Aug 11, 2026
v8Jul 02, 2026
v7Jul 02, 2026
v6Jul 02, 2026
v5Jul 02, 2026
v4Jul 02, 2026
v3Jul 02, 2026

Hizentra: frequently asked questions

Licensure, biosimilar status, exclusivity, and patents for this biologic, from the FDA Purple Book.

Built directly from the FDA Purple Book database of licensed biological products. License types, approval and exclusivity dates, and the patent list match the official FDA record. The Purple Book patent list reflects the statutory BPCIA patent exchange and is not exhaustive.

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