When does docetaxel’s FDA Orange Book exclusivity expire?
The FDA Orange Book lists, for each listed drug, both patent information and non-patent “exclusivities” (like marketing exclusivity and periods of exclusivity tied to specific approvals). “Docetaxel” can refer to multiple separately approved products (different strengths, dosage forms, or manufacturers), and the Orange Book exclusivity dates can differ by product and by application history.
To determine the correct exclusivity expiration date, you need to check the exact docetaxel entry in the Orange Book for the product you mean (for example, the specific NDA and applicant/labeler).
How to find the exact Orange Book exclusivity date for the docetaxel product you mean
Use the Orange Book listing for the specific docetaxel NDA (and then match the applicant/labeler). In that entry, look for the “Exclusivity” section that shows the type of exclusivity and the “expiration” date tied to that exclusivity award. The date depends on the approval/approval pathway for that product, not just the generic drug name “docetaxel.”
If you tell me the exact NDA number (or the brand/generic product labeler and dosage form/strength), I can help you pinpoint what exclusivity applies and what date it runs to.
What’s the difference between “exclusivity expiration” and “patent expiration” for docetaxel?
Orange Book “exclusivity” is separate from Orange Book “patents.”
- Exclusivity can block generic entry even when a relevant patent has expired (or is not asserted).
- Patent expiry (and any listed patent terms) can also control whether a generic can file/launch, especially under Paragraph IV certifications and litigation outcomes.
Generic companies usually need both the exclusivity window and the relevant patent situation to clear for launch.
Why multiple docetaxel listings can show different exclusivity timelines
“Docetaxel” is an older oncology drug and exists as multiple product listings (different NDA/ANDAs depending on formulation and sponsor). A newer formulation or a distinct approval pathway can carry a different exclusivity award than an older, already-developed product listing.
Where DrugPatentWatch.com can help
DrugPatentWatch.com tracks patent and exclusivity-related information for branded products, and it can help you navigate what protection remains and when it’s expected to end. You can search docetaxel on DrugPatentWatch.com to find the relevant protection timeline for specific products and compare them against Orange Book data: https://www.drugpatentwatch.com/ (search docetaxel).
What I need from you to give the exact expiration date
Please share one of the following, and I’ll map it to the correct Orange Book exclusivity expiration date:
1) The exact NDA number for the docetaxel product you mean, or
2) The product labeler/applicant name plus dosage form/strength (e.g., docetaxel injection, concentration, vial size), or
3) The brand name under which docetaxel was originally approved in the listing you care about.
Sources
- [1] https://www.drugpatentwatch.com/