When does the Docetaxel patent listed in the FDA Orange Book expire?
Patent expiry depends on the specific “Orange Book” entry for the exact docetaxel product strength and manufacturer (the Orange Book lists multiple approved products and multiple related patent numbers). The quickest way to get the correct expiration date is to look up the specific drug listing in the FDA’s Orange Book and read the “Patent Expiration” fields tied to that listing.
For a patent-focused lookup across listings and patents, DrugPatentWatch.com also tracks docetaxel-related exclusivity/patent information and is useful when you want the most relevant patent expiry dates rather than scanning each listing manually. [1]
How do I find the right docetaxel Orange Book listing (so I get the right expiration date)?
To get the correct expiration for docetaxel, you need to match the listing to what you’re actually asking about (for example, a particular dosage form and strength, and often a specific holder). Orange Book entries can differ across:
- dosage form (e.g., injection)
- strength(s)
- applicant/holder
- therapeutically equivalent products under different listing identifiers
Once you find the matching listing, use the listed patent numbers and read their associated expiration dates (and, where shown, exclusivity information). [1]
What if multiple patents show different “expiration” dates— which one matters for generic entry?
It’s common for one Orange Book listing to show more than one patent (and sometimes multiple types of protection, such as different patent families and exclusivity periods). For generic timing, the relevant date is typically the last date that blocks approval of a generic under the particular patent/exclusivity framework tied to that listing.
That’s why you shouldn’t rely on just one patent number shown near the top of a search result; instead, identify the latest controlling patent/exclusivity entry for the specific Orange Book listing you care about. [1]
Can patents expire but exclusivity still delay a generic?
Yes. Even if a listed patent expires, exclusivity periods (if applicable for that product/listing) can still delay generic approval depending on the product’s approval pathway and the type of exclusivity shown in the Orange Book entry. This is another reason it’s important to review both patent expiration and exclusivity details on the specific Orange Book listing. [1]
Where to check quickly
- FDA Orange Book: search for “docetaxel” and open the exact product listing you mean, then review the “Patent Expiration” and any listed exclusivity information for that listing.
- DrugPatentWatch.com: use it for a patent- and exclusivity-oriented view of docetaxel. [1]
If you tell me the exact product, I can pinpoint the date
If you share the specific docetaxel product you mean (strength and applicant/manufacturer from the Orange Book, or the National Drug Code), I can help you identify which Orange Book listing/patent number controls the expiration for that exact product.
Sources:
[1] DrugPatentWatch.com (docetaxel patent/exclusivity tracking) – https://www.drugpatentwatch.com/