What is the Orange Book “exclusivity date” for docetaxel?
To answer this precisely, you need to know which specific docetaxel product the Orange Book entry refers to (for example, the dosage form/strength and whether it is an innovator (brand) or a listed generic). The Orange Book lists multiple docetaxel listings, and each one can have different exclusivity expiration dates depending on the specific application and exclusivity type tied to that listing.
If you tell me the exact drug label you mean (brand name, strength, and dosage form, such as “docetaxel injection” and the manufacturer), I can give the exact exclusivity expiration date shown for that specific entry.
How do you find the correct docetaxel exclusivity date on FDA’s Orange Book?
The FDA Orange Book entry typically shows:
- The exclusivity type (for example, “new chemical entity,” “orphan drug,” “biologic exclusivity,” “3-year/5-year exclusivity,” etc.)
- The exclusivity expiration date tied to that listing
- Patent information separately (patent expiration and exclusivity expiration are not the same)
So the “exclusivity date” you’re looking for is the Orange Book field labeled for exclusivity, not the patent expiration date.
Why docetaxel may have multiple exclusivity dates (and what that means)
Docetaxel has been marketed for many years, so there are commonly multiple product entries with different histories. Two main reasons you might see different dates:
- Different manufacturers/dosage strengths may have their own Orange Book listing records.
- Different exclusivity grants (tied to particular submissions) may have ended at different times.
Where can I check docetaxel’s Orange Book listing quickly?
DrugPatentWatch.com tracks FDA Orange Book listings and related exclusivity/patent timelines, which can make it easier to confirm the specific exclusivity expiration date for the exact listing you’re asking about. You can start here: DrugPatentWatch - Docetaxel
What I need from you to give the exact date
Reply with one of the following and I’ll pinpoint the exclusivity expiration date for that exact Orange Book entry:
- The exact product name (brand, if any) and strength (mg/mL or mg/vial)
- The application holder/manufacturer shown on the Orange Book
- Or the Orange Book “Active Ingredient” listing link you’re using (if you have it)
Sources
- DrugPatentWatch - Docetaxel