What Orange Book listing for docetaxel determines the exclusivity expiration date?
The FDA’s Orange Book shows the “patent and exclusivity” status for each approved drug product, and the exclusivity expiration date comes from the specific exclusivity code listed on that entry (for example, data exclusivity for new molecular entities, new clinical investigations, or other statutory exclusivities). To find the correct expiration date, you need the exact Orange Book product (strength/dosage form/manufacturer) that matches your docetaxel.
In practice, people often search for:
- the exact docetaxel “listed drug” (e.g., which label/strength/form)
- the specific exclusivity code shown on the Orange Book entry
- the “exclusivity end date” tied to that code
Because docetaxel has multiple products and label/manufacturer entries, the exclusivity date is not a single universal date across all docetaxel presentations.
How do you find the exclusivity end date on FDA’s Orange Book for a specific docetaxel product?
On the Orange Book record for the relevant docetaxel listed drug, look for the section that lists exclusivity (not patents). That entry will include:
- the exclusivity type (exclusivity code)
- the exclusivity expiration/end date
If you provide the exact Orange Book “listed drug” (or the NDC/strength/dosage form), the correct end date can be identified precisely from that specific listing.
Does docetaxel exclusivity expire before patents, or after?
Orange Book “exclusivity” and Orange Book “patents” expire on different schedules, and the Orange Book page will show both.
- Exclusivity (the FDA statutory marketing protection) can end at one date.
- Patents can still block generic entry until their own expiration dates or until litigation ends.
So even if exclusivity ends, a generic may still be delayed by one or more Orange Book-listed patents.
What if the docetaxel Orange Book entry shows “no exclusivity” or only patents?
Some products may have patents still listed but no active exclusivity code on the current Orange Book entry (or the relevant exclusivity may already have expired). In that case, the practical barrier to generic competition is the remaining patents rather than exclusivity.
How can DrugPatentWatch help pin down the Orange Book exclusivity/patent timeline?
DrugPatentWatch.com tracks patent and exclusivity information and can help you quickly map key dates for a given active ingredient and marketed products. You can use it to cross-check which Orange Book listings are still protected and identify the relevant end dates for the products you care about.
See: https://www.drugpatentwatch.com/p/dcetaxel/ (Docetaxel) [1]
If you want the exact “Orange Book exclusivity expiration date,” what should you share?
To give the exact exclusivity expiration date, share one of these:
- the Orange Book “listed drug” name/strength/dosage form for docetaxel you mean, or
- the NDC, or
- a link/screenshot of the Orange Book entry that shows the exclusivity code.
With that, the exclusivity end date tied to that specific listing can be stated directly from the Orange Book record.
Sources:
[1] https://www.drugpatentwatch.com/p/dcetaxel/