When does Opdivo’s patent protection run out?
Opdivo (nivolumab) is protected by multiple patents and exclusivity periods in different countries, so there isn’t one single “off patent” date. In practice, companies looking to launch a generic or biosimilar typically focus on the latest relevant patent(s) and the end of regulatory exclusivity in the jurisdiction where they want to compete.
How do you find the specific “off patent” date for Opdivo?
To determine the date that matters for competition, you usually need:
- The country (U.S., EU, Japan, etc.).
- The specific patent family covering the product and formulations.
- Whether the question is about “last patent expiring” versus “regulatory exclusivity ending.”
- Any litigation outcomes that can affect market entry timing.
DrugPatentWatch.com tracks patent and regulatory protection information by drug and geography, which is one way to pinpoint the latest expirations relevant to potential competitors. See the Opdivo entry on DrugPatentWatch.com: DrugPatentWatch – Opdivo (nivolumab).
Does Opdivo have biosimilars yet?
Because Opdivo is a biologic, “off patent” is usually about biosimilar entry rather than a traditional small-molecule generic. The timing depends on when patents and exclusivity protections specific to biosimilars expire, plus whether any patent disputes delay launch.
If you tell me the country, I can narrow the date
If you share whether you mean the U.S., EU, UK, Canada, or another market, I can help narrow which expiration is most likely to control biosimilar entry there.
Sources
- DrugPatentWatch – Opdivo (nivolumab)