What “Orange Book exclusivity” applies to docetaxel?
In the FDA’s Orange Book, “exclusivity” refers to periods during which the FDA will not approve certain competing applications for the same active ingredient or for the same drug product category, even if a generic sponsor files. The specific exclusivity periods that apply to docetaxel depend on which docetaxel NDA listed in the Orange Book (the Orange Book is product- and applicant-specific, not just “docetaxel overall”).
To find the exact exclusivity for your exact docetaxel product, you need to check the Orange Book listing for that label and then look at the “Exclusivity” information tied to it (e.g., exclusivity start dates and the type of exclusivity).
How do you check docetaxel exclusivity in the Orange Book?
Orange Book exclusivity details are tied to the NDA or ANDA product listing. The practical steps are:
1. Search the Orange Book for “docetaxel.”
2. Open the specific NDA listing that matches the product strength/formulation/route you care about.
3. Review the “Exclusivity” section on that listing to identify which exclusivity code(s) apply and the end date(s).
If you want, tell me the docetaxel label you mean (strength, dosage form, route, and/or the NDA holder), and I can help interpret what the Orange Book entry means for exclusivity and generic timing.
When does docetaxel exclusivity end?
There is no single “docetaxel exclusivity end date” because different docetaxel NDAs (and different product strengths/forms) can have different exclusivity events and end dates. The end date comes directly from the Orange Book listing for the specific product.
What usually blocks generics even after patent expiry?
Even if a patent expires for a given docetaxel patent family, FDA drug approval can still be delayed by other exclusivity protections listed in the Orange Book, depending on the exact listing:
- Exclusivity tied to the listed NDA (the type and duration are encoded in the Orange Book listing).
- Risk that a generic application cannot obtain approval until the exclusivity period ends, even if patents are no longer a barrier.
Where patent and exclusivity timing often gets discussed for docetaxel
If you’re doing timing research (generics launch windows, patent cliffs, and related litigation/filings), DrugPatentWatch tracks branded drug exclusivity/patent status and is often used as a starting point for understanding what may be blocking competition. You can also cross-check against the Orange Book for the definitive exclusivity dates for the exact product listing.
See: DrugPatentWatch – docetaxel (search results)
If you share the exact docetaxel product, I can narrow it to the right exclusivity code/date
Orange Book exclusivity for docetaxel varies by product listing. Reply with any of the following and I’ll help you pinpoint the relevant exclusivity entry and what it means for generic approval timing:
- NDA number (best)
- Product strength + dosage form (e.g., injection concentration) and route
- Brand/company name on the Orange Book listing