omalizumab (Xolair)
omalizumab is an FDA-licensed reference biologic from Genentech, Inc., with 1 approved follow-on biologic. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
1
Interchangeables
8
Listed patents
2023
Reference approved
Reference product
Xolair omalizumab
Genentech, Inc.
- Approved
- Aug 17, 2023
- Marketing
- Rx
- Center
- CDER
- Patents
- 8 listed
Molecular structure
Experimental 3D structure for omalizumab from the RCSB Protein Data Bank (PDB 2XA8).
Interactive biological assembly from PDB entry 2XA8. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for omalizumab, in chronological order.
Reference approval
Approval date of the reference omalizumab product.
2 yr 10 mo ago
Patent 10,034,940 expires
Published Purple Book patent expiration.
7 mo ago
Patent 11,078,294 expires
Published Purple Book patent expiration.
in 2 yr 2 mo
Patent 11,987,637 expires
Published Purple Book patent expiration.
in 2 yr 2 mo
Patent 8,574,869 expires
Published Purple Book patent expiration.
in 2 yr 2 mo
Patent 10,017,732 expires
Published Purple Book patent expiration.
in 7 yr 11 mo
Patent 10,676,710 expires
Published Purple Book patent expiration.
in 7 yr 11 mo
Patent 10,829,732 expires
Published Purple Book patent expiration.
in 7 yr 11 mo
Patent 12,030,959 expires
Published Purple Book patent expiration.
in 17 yr 5 mo
Biosimilars & interchangeables for omalizumab
1 FDA-licensed follow-on biologic referencing omalizumab.
| Product | Proper name | Applicant | Type | BLA | Approved |
|---|---|---|---|---|---|
| Omlyclo | omalizumab-igec | CELLTRION, Inc. | Interchangeable | 761399 | Mar 07, 2025 |
Published patents
Patents the BLA holder has published in the FDA Purple Book Patent List for omalizumab.
| Patent | Expires | In |
|---|---|---|
| 10,034,940 | Nov 04, 2025 | 7 mo ago |
| 11,078,294 | Jul 08, 2028 | in 2 yr 2 mo |
| 11,987,637 | Jul 08, 2028 | in 2 yr 2 mo |
| 8,574,869 | Jul 08, 2028 | in 2 yr 2 mo |
| 10,017,732 | Mar 14, 2034 | in 7 yr 11 mo |
| 10,676,710 | Mar 14, 2034 | in 7 yr 11 mo |
| 10,829,732 | Mar 14, 2034 | in 7 yr 11 mo |
| 12,030,959 | Jul 20, 2043 | in 17 yr 5 mo |
Frequently asked questions
What biosimilars are approved for omalizumab (Xolair)?
The FDA Purple Book lists 1 approved follow-on biologic referencing omalizumab: Omlyclo. Of these, 1 is an interchangeable biosimilar and 0 are 351(k) biosimilars.
Is there an interchangeable biosimilar for omalizumab?
Yes. Omlyclo is approved as interchangeable biosimilar for omalizumab, meaning it may be substituted for the reference product at the pharmacy without prescriber involvement, subject to state law.
Who makes omalizumab biosimilars?
Companies with FDA-approved follow-on biologics referencing omalizumab include CELLTRION, Inc..
How many patents are listed for omalizumab (Xolair) in the Purple Book?
8 patents are published in the FDA Purple Book Patent List for omalizumab.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.