Opdivo Patent Protection
0 patents · Bristol-Myers Squibb Company
Biosimilar Pathway
Opdivo (nivolumab) is a biologic, not a small-molecule drug. Biologics are not listed in the FDA Orange Book and do not face conventional “generic” competition. Instead, follow-on competitors called biosimilars can be approved through the FDA’s BPCIA pathway, typically after the reference product’s 12-year exclusivity period and the resolution of any patent litigation.
For the current biosimilar approvals and exclusivity status of Opdivo, see the authoritative FDA Purple Book listing for nivolumab.
Related Drug Patent Expirations
2 patents · earliest expires 2027 · Bristol-Myers Squibb Company
0 patents · Genentech Inc.
9 patents · earliest expires 2033 · Gilead Sciences Inc.
0 patents · Novartis AG
0 patents · Janssen Biotech Inc.
0 patents · Regeneron Pharmaceuticals Inc.
For Opdivo, the underlying data on this page comes from the FDA Orange Book and USPTO patent records. The breakdown above is the federal record; the paragraphs below add the per-entity context that makes the headline numbers usable for a real decision rather than just a data lookup.
The methodology behind every numeric value on this page is publicly documented on the the FDA Orange Book and USPTO patent records portal and described in detail on this site’s methodology page. Refresh cadence varies by underlying series; the page surfaces the as-of date for each number so readers can trace any figure back to the source release.
Practical use of this page is in combination with the comparison and ranking pages elsewhere on the site, which surface the same data for Opdivo’s peers within U.S. brand-name drugs. A single-entity reading without peer context can be misleading when an entity is an outlier on one axis but typical on another.