What is Xolair in the FDA Purple Book?

Xolair, BLA 103976, is listed as a 351(a) reference biologic with 7 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 103976?

Xolair, BLA 103976, lists Genentech, Inc. 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 Xolair?

Xolair, BLA 103976, has 7 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 Xolair's reference-product relationship?

Xolair, BLA 103976, is supported as a reference biologic by exact-BLA evidence and has 1 name-linked 351(k) follow-on product in the loaded snapshot. This answer is limited to the current FDA Purple Book record and its exact BLA-level fields.

Is Xolair interchangeable?

Xolair, BLA 103976, 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 Xolair licensed by FDA?

Xolair, BLA 103976, has a listed FDA approval date of Aug 17, 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 Xolair's FDA label?

Xolair, BLA 103976, 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 Xolair?

Xolair, BLA 103976, has 8 published Purple Book patent rows, with the latest listed expiration on Jul 20, 2043. FDA publishes sponsor-provided patent information ministerially; these rows are not conclusions about validity, infringement, freedom to operate, or market entry.

What exclusivity information is listed for Xolair?

Xolair, BLA 103976, has no populated exclusivity date in the loaded Purple Book row. Missing database fields do not prove that no regulatory or legal constraints exist, and this page does not calculate a market-entry date.

FDA Purple Book product · 351(a) biologic

Xolair

omalizumab

Xolair, BLA 103976, is listed in the FDA Purple Book as a 351(a) reference biologic. This page consolidates 7 exact FDA presentation rows, and 1 FDA rows name-link 351(k) follow-on products to its reference family. 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 103976 7 presentationsRxLicensed Genentech, Inc.

Approved

Aug 17, 2023

License type

351(a)

Marketing

Listed patents

Xolair (omalizumab) is Genentech, Inc.'s FDA-licensed 351(a) biologic under BLA 103976, approved in 2023. The FDA Purple Book lists 8 published patents for it, the last expiring 2043. 1 distinct approved follow-on biologic explicitly reference Xolair (Omlyclo), making its reference-product role visible in the loaded family data.

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

What this Purple Book record establishes

Regulatory interpretation

BLA number

103976

Regulatory role

351(a) reference biologic

Applicant

Genentech, Inc.

Applicant is not automatically the physical manufacturer.

Presentations

Exact FDA presentation rows under this BLA.

Approval

Aug 17, 2023

Follow-on biologics

Xolair is a 351(a) reference biologic supported by exact-BLA evidence.

1 distinct licensed follow-on biologic in the loaded Purple Book data name Xolair as their reference product; exact-BLA patent or exclusivity fields, or an unambiguous single-BLA name match, support this page's role.

Substitution boundary

Substitution status belongs to an individual follow-on product; it cannot be inferred from the reference product alone.

Key dates

Licensure & exclusivity

Approval
Approval date of this BLA submission.
Aug 17, 2023
3 yr 2 mo ago
Today

Strengths & presentations

7 FDA presentation rows · BLA 103976

Strength

150MG

Dosage form

For Injection

Route

Subcutaneous

Presentation

Single-Dose Vial

Center

CDER

License number

1048

Product number

001

Submission type

Original

Supplement number

Not listed

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	150MG	For Injection	Subcutaneous	Single-Dose Vial	Licensed	Rx
002	75MG/0.5ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx
003	150MG/ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx
004	300MG/2ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx
005	75MG/0.5ML	Injection	Subcutaneous	Autoinjector	Licensed	Rx
006	150MG/ML	Injection	Subcutaneous	Autoinjector	Licensed	Rx
007	300MG/2ML	Injection	Subcutaneous	Autoinjector	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

1 distinct 351(k) follow-on biologic are linked through FDA-stated reference names to Xolair; 1 is designated interchangeable and 1 has a licensed status in the loaded snapshot.

Exact-BLA patent, exclusivity, or unambiguous linked-family evidence supports this page's reference role. Name-linked licensed biosimilars and interchangeables are listed below.

OmlycloInterchangeable
omalizumab-igec · CELLTRION, Inc.
2025

Reference-family comparison

Purple Book comparison of products in this reference family
Product	Designation	BLA	Approved	Presentation	Marketing
Xolairomalizumab	351(a) reference biologic	103976	Aug 17, 2023	300MG/2ML · Subcutaneous	Rx
Omlycloomalizumab-igec	351(k) interchangeable biosimilar	761399	Mar 07, 2025	75MG/0.5ML · Subcutaneous	Rx

Published patents

BPCIA patent list

Patents published in the FDA Purple Book Patent List for this product, with expiration date and source link.
Patent	Expires	In	Source
10,034,940	Nov 04, 2025	11 mo ago	FDA
11,078,294	Jul 08, 2028	in 1 yr 10 mo	FDA
11,987,637	Jul 08, 2028	in 1 yr 10 mo	FDA
8,574,869	Jul 08, 2028	in 1 yr 10 mo	FDA
10,017,732	Mar 14, 2034	in 7 yr 7 mo	FDA
10,676,710	Mar 14, 2034	in 7 yr 7 mo	FDA
10,829,732	Mar 14, 2034	in 7 yr 7 mo	FDA
12,030,959	Jul 20, 2043	in 17 yr 1 mo	FDA

Practical characteristics and limits

Source-bounded interpretation

Presentation coverage

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

Administration fields

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

Applicant boundary

Genentech, Inc. 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

Xolair is a 351(a) reference biologic supported by exact-BLA evidence. 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

v5Aug 11, 2026
v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Xolair: 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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