What exclusivity expiration date does the FDA “Purple Book” show for nivolumab (Opdivo) as the reference product?
The FDA’s “Purple Book” lists biological product exclusivity for reference products, including the expiration date tied to the reference product’s exclusivity. For nivolumab, that reference product is Opdivo, and the Purple Book entry is where you can look up the specific exclusivity expiration date used for substitution and biosimilar review timing. [1]
If you tell me the exact Purple Book listing you’re looking at (trade name, manufacturer, or the “application/licence number” shown on the page), I can help pinpoint the exact “Exclusivity Expiration Date” value from that specific record.
How do I find the right Purple Book record for nivolumab?
On the Purple Book site, search for:
- “nivolumab” or “Opdivo” and then open the record that matches the manufacturer/license shown for the reference product. [1]
Because there can be multiple listings (for example, by sponsor, strength, or submission history), using the exact trade name/manufacturer record is the fastest way to avoid grabbing the wrong exclusivity expiration date.
What exactly does “exclusivity” mean in the Purple Book for a reference product like Opdivo?
In Purple Book context, “exclusivity” is tied to periods during which FDA generally does not allow approval of an interchangeable or biosimilar application that relies on the reference product in certain ways, even if the biosimilar has clinical and analytical support. The Purple Book is the public index for those exclusivity blocks and their expiration dates. [1]
Are there different exclusivities or “extensions” that affect when biosimilars can be approved?
The Purple Book captures exclusivity information by record, and the relevant expiration date shown there is what FDA uses for that specific exclusivity period. Practically, different exclusivity awards (or changes reflected in the record) can affect the timing, which is why checking the exact Purple Book entry for the reference product record you care about is important. [1]
Where can I verify the date quickly?
Use the FDA Purple Book lookup page and search for the reference product record for Opdivo/nivolumab to view the “Exclusivity Expiration Date” listed for that record. [1]
Sources:
[1] https://purplebooksearch.fda.gov/