Nivolumab
As of the edition of 20 October 2026, Nivolumab is an antibody: marketed, first approved in 2014 (JP); acts on PDCD1; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Antibody
- Brand name
- Opdivo
- First approved
- 4 July 2014 (JP)
- Approvals on record
- 45 in 5 regions
- Holder of the most recent approval
- Bristol Myers Squibb; 2 holders in all
- Withdrawn from market
- 30 November 2015 (in some regions)
- Registered trials
- 1,609, 308 stopped early
- Disease areas
- Cancer; Digestive system; Skin and connective tissue; Lungs and airways; Urinary and reproductive; Pregnancy and women's health
US protection
US protection ends in 2031.
The orphan exclusivity ends in 2031 (it covers one use only). The application that gives this date is held by Bristol Myers Squibb.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product5 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Nivolumab.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PDCD1 | Programmed cell death protein 1 | Q15116 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 69 | 30 | 21 | 3 |
| Phase 1 | 375 | 159 | 114 | 84 |
| Phase 2 | 1,001 | 359 | 353 | 202 |
| Phase 3 | 151 | 65 | 62 | 18 |
| Phase 4 | 13 | 6 | 4 | 1 |
| All trials | 1,609 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Ono Pharmaceutical | Applicant and Lead sponsor of trials | 2009 to now |
| Bristol Myers Squibb | Applicant and Lead sponsor of trials | 2014 to now |