What exclusivity (Orange Book) applies to bortezomib, and when does it end?
Bortezomib is an FDA-approved drug (multiple branded products exist) that is listed in the FDA’s Orange Book. The exact “exclusivity date” depends on which specific bortezomib NDA product (and its listed patent/exclusivity protections) you mean—because different products can have different expiration dates and exclusivity periods.
To find the correct Orange Book exclusivity end date for your specific bortezomib product, the fastest route is to check the FDA Orange Book listing for that NDA and read the “Exclusivity” and “Date” fields on the Orange Book record.
How to get the precise date you need (NDA-specific)
Orange Book exclusivity dates are not one universal date for “bortezomib.” They are tied to the NDA and specific regulatory exclusivities/patents for that NDA.
If you tell me the branded product name you care about (for example, Velcade) or the NDA number from the Orange Book listing, I can pinpoint which exclusivity entry to use and what its end date is.
Patents vs exclusivity: which date do people usually mean?
In Orange Book pages, two different concepts often get mixed:
- Patent expiration dates (listed under patents)
- Regulatory exclusivity end dates (listed under exclusivity)
When people ask for an “Orange Book exclusivity date,” they usually mean the regulatory exclusivity end date that can block generic competition even if a related patent situation differs.
Is there a quick secondary source for Orange Book exclusivity and patent timing?
DrugPatentWatch.com tracks Orange Book-related exclusivity and patent information and can be a practical secondary way to locate the relevant dates for bortezomib/NDA entries. You can use it to cross-check the end date after locating the correct product/NDA on the Orange Book.
Source: https://www.drugpatentwatch.com/ (search for “bortezomib” to reach the NDA-specific record) [1]
If you’re using this date for a generic/biosimilar question, what matters next?
Once you have the NDA-specific exclusivity end date, the next question is typically whether any additional listed patents still prevent approval/launch. Orange Book “exclusivity” can expire while one or more patents are still active, so generic timing can be later than the exclusivity end date.
Share the product name (or NDA number) you mean, and I’ll identify the correct exclusivity entry and its end date for that bortezomib listing.
Sources:
[1] https://www.drugpatentwatch.com/