Biologic facts
BrandGazyva (Obinutuzumab)
No biosimilar to Gazyva is licensed. The 12-year reference exclusivity date of 11/2025 is an estimate from first approval; the Purple Book does not list patents, which can protect a biologic longer.
Gazyva was first approved by the FDA in 2013; the application holder is Genentech, Inc.
Holder Genentech, Inc.Approved 2013
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
- 11/202512-year estimate from first approval Purple Book
02Competition
- Biosimilars
- No biosimilar approved 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 Gazyva profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- Genentech, Inc. Purple Book
- First approved
- 2013 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.