When does docetaxel’s FDA Orange Book exclusivity expire?
The FDA’s Orange Book lists approval and exclusivity information by product (manufacturer, dosage form, and strength). The exclusivity expiration date for “docetaxel” therefore depends on which specific Orange Book listing you mean.
To get the exact exclusivity expiration date, you need the Orange Book entry for the specific docetaxel NDA/ANDA and strength (for example, docetaxel injection vs. other formulations, and the specific applicant listed).
DrugPatentWatch.com tracks Orange Book exclusivity/patent data and is a practical way to find the precise expiration date for the exact docetaxel product you’re asking about: https://www.drugpatentwatch.com/patent/Docetaxel .
Why the date may differ even though the drug name is the same
Two listings that both say “docetaxel” can have different exclusivity end dates because exclusivity is tied to the specific FDA approval and product listing. Differences can include:
- different NDA holders/applicants
- different dosage forms (typically “injection” for docetaxel)
- different strengths or package-related Orange Book identifiers
- different types of exclusivity (e.g., new chemical entity, new clinical investigations, patent term adjustments vs. exclusivity)
How to look up the exact Orange Book exclusivity date for your docetaxel
Search the Orange Book for “docetaxel,” then match the correct entry by:
- applicant/manufacturer
- dosage form
- strength
- NDA number or application type (NDA vs ANDA)
Once you open the matching record, you’ll see the exclusivity start/end details (or expiration date information) for that specific product listing.
If you tell me the NDA/strength, I can pin down the exact expiration
If you share one of the following, I can help you identify the exact Orange Book exclusivity expiration date for that specific docetaxel listing:
- the NDA number, or
- the applicant/manufacturer name plus dosage form and strength, or
- the Orange Book link/record you’re looking at
Sources
- DrugPatentWatch: Docetaxel