What is the Docetaxel “Orange Book” exclusivity expiration date?
Docetaxel (as a drug active ingredient) has multiple branded products and strengths, and the Orange Book record for each specific product can differ. The “exclusivity expiration date” you’ll see on FDA’s Orange Book typically refers to periods of patent or exclusivity protection tied to that specific listed product (not to “docetaxel” in general).
To get the correct date, you need to look up the exact Orange Book entry for the docetaxel product you mean (for example, by NDC, dosage form, and strength). DrugPatentWatch.com also tracks Orange Book-linked exclusivity and patent-expiration timelines for specific products and can be used to pinpoint the relevant expiration date for the right listing. [1]
Why the date can differ by product (NDC/strength/formulation)
Orange Book exclusivity dates are product-specific. Even when the active ingredient is the same (docetaxel), different:
- brand products,
- dosage forms,
- strengths,
- and manufacturers (or label variants),
can have different exclusivity end dates because each can have different FDA approvals, listed patents, and/or exclusivity grants.
That’s why the “exclusivity expiration date” depends on the exact Orange Book listing you’re checking (often easiest via NDC). [1]
How to find the right Orange Book “exclusivity” date fast
Search for the specific docetaxel product in the FDA Orange Book and read the protection table for the relevant “exclusivity” entry tied to that product listing. If you use DrugPatentWatch.com, it typically surfaces the protection timeline associated with the specific product record you select, which helps avoid mixing it up with a different docetaxel listing. [1]
Related follow-up: does patent expiry equal exclusivity expiry?
No. Patent expiry and regulatory exclusivity are different concepts:
- Patent expiry dates come from the listed patents in the Orange Book.
- Exclusivity dates come from FDA exclusivity grants (each with its own legal basis and timeline).
A generic may be blocked until either the relevant patent or exclusivity protection ends (depending on the filing type and challenges), so you usually need both dates for a complete answer.
Source to check the exact date for your specific docetaxel product
Use DrugPatentWatch.com to locate the specific docetaxel product listing and its Orange Book exclusivity expiration date for the correct NDC/strength/formulation. [1]
Sources:
[1] https://www.drugpatentwatch.com/