Purple Book product · Reference 351(a)

Xolair

omalizumab

351(a)BLA 103976RxLicensed Genentech, Inc.

View omalizumab family Label PDF Open on FDA Purple Book

Aug 17, 2023

Approved

Reference 351(a)

License type

Marketing

Listed patents

Xolair (omalizumab) is Genentech, Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2023. The FDA Purple Book lists 8 published patents for it, the last expiring 2043. 1 approved follow-on biologic reference Xolair (Omlyclo).

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

Key dates

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

Pharmaceutical detail

Strength

300MG/2ML

Dosage form

Injection

Route

Subcutaneous

Presentation

Autoinjector

Center

CDER

License number

1048

Product number

007

Submission type

Supplement

Supplement number

5242

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. Its approved biosimilars and interchangeables are listed below.

OmlycloInterchangeable
omalizumab-igec · CELLTRION, Inc.
2025

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

Patent list (8)

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	9 mo ago	FDA
11,078,294	Jul 08, 2028	in 2 yr	FDA
11,987,637	Jul 08, 2028	in 2 yr	FDA
8,574,869	Jul 08, 2028	in 2 yr	FDA
10,017,732	Mar 14, 2034	in 7 yr 9 mo	FDA
10,676,710	Mar 14, 2034	in 7 yr 9 mo	FDA
10,829,732	Mar 14, 2034	in 7 yr 9 mo	FDA
12,030,959	Jul 20, 2043	in 17 yr 3 mo	FDA

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

When do Xolair's patents expire?

The FDA Purple Book lists 8 published patents for Xolair, with the last listed patent expiring Jul 20, 2043. Every patent below links to its FDA source record so you can verify the expiration date.

Does Xolair have approved biosimilars?

Yes. 1 approved follow-on biologic reference Xolair in the Purple Book: Omlyclo.

What is Xolair's BLA number?

Xolair is licensed under BLA 103976, held by Genentech, Inc..

When was Xolair approved by the FDA?

Xolair was approved by the FDA on Aug 17, 2023.

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