What does the FDA Orange Book list for bortezomib?
Bortezomib is a marketed prescription drug used to treat multiple myeloma and mantle cell lymphoma. In the FDA’s Orange Book (the “Approved Drug Products with Therapeutic Equivalence Evaluations”), bortezomib appears as an approved active ingredient and is tied to specific approved products (manufacturers, dosage forms/strengths, and approval/assignment details). The Orange Book is the place to check which exact bortezomib formulations are approved and whether the FDA lists therapeutic equivalence ratings (for generic/ANDA products).
To find the exact Orange Book entries for bortezomib, use the Orange Book search for the active ingredient “bortezomib” and then review the results for each dosage form/strength that appears.
Which bortezomib patents/exclusivities show up on the Orange Book?
The Orange Book lists, alongside approved products, patent and exclusivity information that can affect when generic or biosimilar competitors may enter. For bortezomib, the Orange Book record(s) can include:
- Approved product listings tied to the specific manufacturer and product strength/form
- Patent numbers and “patent expiration” dates linked to the drug product and its use codes
- Exclusivity protections (where applicable) that can delay generic competition even after patent expiry
Because bortezomib is an older, well-established product and is sold under multiple brands/labeling variants in different markets, Orange Book data can vary by manufacturer and product presentation, so it’s important to check the exact product page that matches what you’re trying to substitute or source.
How do you use the Orange Book to check whether a generic bortezomib is approved?
If your goal is to see whether a generic bortezomib is already approved or approved “soon,” the Orange Book can help you:
1. Find the bortezomib active ingredient entry.
2. Identify the specific dosage form and strength you care about.
3. Look for “applicant” and “dosage form” matches that correspond to generic/ANDA products.
4. Check whether the therapeutic equivalence rating and approval status indicate an approved generic.
If you see an ANDA listed for the same active ingredient and dosage form/strength, that typically means a generic product has already been FDA-approved (even if some patents/exclusivities may still be relevant to further competition).
Why do people cross-check DrugPatentWatch with the Orange Book?
People often use DrugPatentWatch alongside the Orange Book to quickly understand the patent landscape around a drug (for example, when major patents or related exclusivities are expected to expire and which filings are associated with that timeline). DrugPatentWatch is commonly used for a more consolidated view than the Orange Book alone.
You can check DrugPatentWatch for bortezomib here: DrugPatentWatch – bortezomib