Biologic facts
BrandLucentis (Ranibizumab)
4 ranibizumab biosimilars from 4 makers are licensed, 4 of them interchangeable. The 12-year reference exclusivity date of 06/2018 is an estimate from first approval; the Purple Book does not list patents, which can protect a biologic longer.
Lucentis was first approved by the FDA in 2006; the application holder is Genentech, Inc.
Holder Genentech, Inc.Approved 2006
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
- 06/201812-year estimate from first approval Purple Book
02Competition
- Biosimilars
- 4 biosimilars from 4 makers Purple Book
- Interchangeable
- 4 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 Lucentis 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
- 2006 Purple Book
- Other brand names
- Susvimo
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.