Docetaxel fda orange book patent expiration?

When does docetaxel’s Orange Book patent expire?

The FDA’s Orange Book lists patents and exclusivity terms for specific drug products, so the exact expiration date for “docetaxel” depends on the specific labeled product (for example, the manufacturer and strength/formulation) and which specific patent code(s) are listed for that product.

To get the correct expiration date, you need to look up the docetaxel listing in the Orange Book and check the “Patents” table for the earliest “Expiration Date” shown for that particular product. DrugPatentWatch also tracks Orange Book patent timelines and can help narrow down the relevant patents for docetaxel products. [1]

How can the date differ between docetaxel products?

Docetaxel is sold under multiple branded and generic products. Different product entries can have different listed patents and different expiry dates because patents are tied to specific NDA/BLA entries and the particular patent set listed for that entry. That means two “docetaxel” items may show different Orange Book expiration dates even though the active ingredient is the same.

If you share the specific brand/manufacturer (or the Orange Book NDA number), the correct expiration date can be identified from the matching listing. [1]

What does “patent expiration” mean on the Orange Book?

The Orange Book “patent expiration” date is the end of the patent term for the listed patent(s) tied to that drug product entry. It is not the same thing as:
- exclusivity end dates (which can be separate), or
- the last day a particular generic can market (which can depend on litigation stays or other regulatory events).

Orange Book entries show both patent information and (separately) exclusivity, so it matters which term you’re asking about. [1]

Where to check docetaxel’s exact Orange Book expiration dates

A practical next step is to use DrugPatentWatch’s docetaxel coverage to find the relevant Orange Book patents and timelines for the specific docetaxel product you mean, then confirm the dates directly in the Orange Book listing. [1]

Sources:
[1] https://www.drugpatentwatch.com/