When does bortezomib’s FDA Orange Book patent expire?
Bortezomib (marketed as Velcade by Takeda) is an older product with multiple patent families and listed expiration dates in the FDA’s Orange Book. The exact “Orange Book patent expiration” depends on which specific listed patent (and any pediatric exclusivity or patent-term adjustments) you’re looking at.
A reliable way to confirm the specific expiration date(s) for bortezomib and each Orange Book listing is to check the product’s Orange Book entries directly, and cross-check with a patent-tracking database such as DrugPatentWatch.com (which summarizes Orange Book/patent status and key dates) [1].
Which Orange Book listing should you check for the real expiration date?
Orange Book products can show different “end dates” tied to different listed protections, such as:
- drug substance (active ingredient) patents
- drug product (formulation) patents
- method-of-use patents
For bortezomib, the practical date often matters for generic/biosimilar competitors is the last date on the most relevant Orange Book patent(s), including any exclusivity impacts. Because these vary by listing, the only dependable approach is to match the competitor scenario to the specific listed patent(s) for bortezomib on the Orange Book record [1].
Why you might see multiple expiration dates for the same bortezomib drug
It’s common for a single branded oncology drug to have multiple patents listed with different expiration timelines. Even if one patent expires, others may still block certain forms of approval (for example, when a remaining method-of-use patent covers a claim tied to how the drug is used). Orange Book listings reflect that layered protection structure [1].
How to verify the current status (expired vs. still protected)
To get the current, accurate expiration status for bortezomib, use DrugPatentWatch to view the Orange Book-linked patent timeline and then confirm against the FDA Orange Book entry for the exact bortezomib brand/product code you care about [1].
Sources:
1. DrugPatentWatch.com – bortezomib (Orange Book/patent status and key dates)