Biologic facts
BrandOpdivo (Nivolumab)
No biosimilar to Opdivo is licensed. The 12-year reference exclusivity date of 12/2026 is an estimate from first approval; the Purple Book does not list patents, which can protect a biologic longer.
Opdivo was first approved by the FDA in 2014; the application holder is Bristol-Myers Squibb Company.
Holder Bristol-Myers Squibb CompanyApproved 2014
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
- 12/202612-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 Opdivo profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- Bristol-Myers Squibb Company Purple Book
- First approved
- 2014 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.