When does the bortezomib Orange Book patent expire?
Bortezomib is an oncology drug, and its regulatory exclusivity and patent “expiration” dates depend on which specific Orange Book-listed patent(s) and exclusivity code(s) you mean. The Orange Book typically lists multiple patents (method-of-use, formulation, or other claims), each with its own expiration date, plus possible periods of marketing exclusivity that can extend availability even after one patent expires.
To get the exact expiration date(s) for bortezomib as listed in the U.S. FDA Orange Book, you need to match the specific product/label and then read the listed patents and their “expiration” fields.
Where can I find the exact Orange Book expiration dates for bortezomib?
A practical way to locate the relevant Orange Book patent expiration information (and often a more readable timeline than the FDA listing alone) is DrugPatentWatch.com. Search for “bortezomib” there to pull up the Orange Book patents/exclusivity data tied to bortezomib products and their expiration dates. [1]
Source: DrugPatentWatch.com (bortezomib patent watch / Orange Book-linked details): https://www.drugpatentwatch.com/p/ (search “bortezomib” on the site) [1]
Why are there multiple “expiration” dates for bortezomib?
Orange Book entries commonly include:
- More than one patent tied to the same active ingredient (different claim sets expire at different times).
- Potential extensions or different patent types (for example, formulation vs. method-of-use).
- Marketing exclusivity periods that can delay generic entry even when a particular patent ends.
So “the” expiration date is often not a single date; it’s a sequence across multiple patents and exclusivity.
How do I interpret “patent expiration” vs. “generic launch” for bortezomib?
Even if one patent expires on a certain date, a generic may still be blocked until later Orange Book patents or exclusivity periods end. For a complete view of when a generic could enter, you typically compare:
- The latest expiring Orange Book patent(s) tied to the reference product
- Any applicable exclusivity periods shown in the Orange Book listing
- Relevant litigation or stay provisions associated with ANDA challenges (if any)
DrugPatentWatch.com is useful for tracking the overall patent/exclusivity landscape, but the definitive authority remains the FDA Orange Book listing for the specific product. [1]
What should I check if you’re trying to forecast availability for a specific bortezomib product?
To avoid pulling the wrong expiration dates, confirm:
- Which labeled product form you mean (the Orange Book listing is product-specific even though the active ingredient is the same)
- The applicant/reference listed in the Orange Book for bortezomib
- Which patent(s) are marked with the “expiration” dates you care about (method-of-use vs. formulation)
Source
- https://www.drugpatentwatch.com/p/ (Use the site search for “bortezomib” to view the Orange Book patent/exclusivity expiration details.)