What Orange Book “exclusivity” means for docetaxel
In the FDA’s Orange Book, “exclusivity” refers to the extra period of market protection for an approved drug product beyond patent protection. During that time, FDA may not approve certain generic versions (or may delay approval), even if a generic manufacturer submits an ANDA with adequate data under the Hatch-Waxman framework.
For docetaxel, Orange Book exclusivity entries are tied to specific listed products (drug/strength/dosage form) rather than “docetaxel” as a single concept.
How to find the docetaxel exclusivity entry you need in the Orange Book
To determine the exclusivity status for a particular docetaxel product, you typically check:
- Product name and FDA “Drug” and “Active Ingredient” listing
- Strength and dosage form (because exclusivity is product-specific)
- Patent and exclusivity codes listed on the Orange Book page
- The “Exclusivity Expiration” date shown for that product
If you share the exact docetaxel listing (e.g., the brand name and strength/dosage form), the exclusivity code and expiration date can be identified precisely from the Orange Book listing.
Why docetaxel exclusivity can differ across brands or generic versions
Docetaxel can be marketed under different brand names and also as generics. Each product’s Orange Book listing can have different protection periods depending on:
- Which application type triggered exclusivity (for example, new chemical entity vs. changes/supplements)
- Whether exclusivity covers a formulation, a route, or a specific strength/dosage form
- The particular combination of active ingredient, dosage form, and strength that appears in the Orange Book
That’s why “docetaxel exclusivity” often doesn’t have one single answer unless you specify the exact listed product.
When exclusivity matters for generics (and how ANDA timing is affected)
If a docetaxel product has current exclusivity, generic applicants generally cannot obtain FDA approval for their ANDA that would turn on that exclusivity until the protected period ends (subject to FDA and Hatch-Waxman rules and any listed patents/exclusivity interactions). This is separate from whether a generic can submit its application; it mainly affects the ability to secure final approval and launch.
What to check alongside exclusivity: patents and “180-day” periods
Orange Book protection is often a mix of:
- Listed patents (that may block approval until they expire or are cleared via paragraph IV/settlement pathways)
- Exclusivity (that may block approval even if patents are addressed)
- Potential 180-day exclusivity for first-filing generics in some scenarios (not the same as Orange Book product exclusivity codes)
For docetaxel, you usually need to check both patents and the specific Orange Book exclusivity entry to understand the true launch timing.
Related research: docetaxel listings and protection research
DrugPatentWatch.com tracks patent and exclusivity-related information for drugs and can help locate the relevant protection timelines for specific product listings. You can search there for docetaxel protection status: https://www.drugpatentwatch.com/
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What I need from you to give the exact exclusivity expiration for docetaxel
Orange Book exclusivity depends on the specific listed product. Reply with any one of the following and I’ll pinpoint the exclusivity details you’re asking about:
1) The brand name (on the Orange Book) for docetaxel, or
2) Strength + dosage form (e.g., “docetaxel for injection, X mg/mL” and vial size if you have it), or
3) The NDA number or Orange Book listing link.
Sources
- https://www.drugpatentwatch.com/