Purple Book product · Interchangeable

Omlyclo

omalizumab-igec

351(k) InterchangeableBLA 761399RxLicensed CELLTRION, Inc.

View omalizumab family Label PDF Open on FDA Purple Book

Mar 07, 2025

Approved

Interchangeable

License type

Marketing

Listed patents

Omlyclo (omalizumab-igec) is a Interchangeable referencing omalizumab, licensed under a 351(k) BLA in 2025 and marketed by CELLTRION, Inc.. As an interchangeable biosimilar it may be substituted for the reference product at the pharmacy without prescriber involvement, subject to state law. The Purple Book lists 8 published patents for this product.

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

Key dates

Approval
Approval date of this BLA submission.
Mar 07, 2025
1 yr 5 mo ago
Today

Pharmaceutical detail

Strength

150MG/ML

Dosage form

Injection

Route

Subcutaneous

Presentation

Pre-Filled Syringe

Center

CDER

License number

1996

Product number

002

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Reference product family

View full family

Biosimilar of omalizumab (Xolair)

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

v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

When do Omlyclo's patents expire?

The FDA Purple Book lists 8 published patents for Omlyclo, 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.

Is Omlyclo a biosimilar?

Yes. Omlyclo is a Interchangeable referencing omalizumab, licensed under a 351(k) BLA.

Is Omlyclo interchangeable?

Yes. Omlyclo carries an FDA interchangeability designation, so it may be substituted for the reference product at the pharmacy without prescriber involvement, subject to state law.

What is Omlyclo's BLA number?

Omlyclo is licensed under BLA 761399, held by CELLTRION, Inc..

When was Omlyclo approved by the FDA?

Omlyclo was approved by the FDA on Mar 07, 2025.

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