Biologic facts
BrandXolair (Omalizumab)
1 omalizumab biosimilar from 1 maker is licensed, 1 of them interchangeable. The 12-year reference exclusivity date of 06/2015 is an estimate from first approval; the Purple Book does not list patents, which can protect a biologic longer.
Xolair was first approved by the FDA in 2003; the application holder is Genentech, Inc.
The most recent FDA recall on record is a Class II recall dated 07/30/2025.
Holder Genentech, Inc.Approved 2003
01Exclusivity
When biosimilar competition can legally begin. The Purple Book lists reference exclusivity but not patents, which can protect a biologic longer.
- Patents
- Not listed in the Purple Book Purple Book
- Reference exclusivity
- 06/201512-year estimate from first approval Purple Book
02Competition
- Biosimilars
- 1 biosimilar from 1 maker Purple Book
- Interchangeable
- 1 Purple Book
Every makerEach licensed product and biosimilar maker.
PrescribersWho prescribes it, from Medicare data.
Spend and safetyMedicare Part B spend and safety reports.
Available in the full Xolair profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- Latest recall
- 07/30/2025Class II, Omalizumab, Cardinal Health Inc. FDA enforcement
04Product
- Application holder
- Genentech, Inc. Purple Book
- First approved
- 2003 Purple Book
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.