What “exclusivity date” means on the FDA Orange Book for docetaxel
The FDA Orange Book lists patents and, separately, exclusivity periods tied to specific drug applications (for example, New Chemical Entity exclusivity or other regulatory exclusivities). The “exclusivity date” people search for is the calendar date when the listed exclusivity (not necessarily patent protection) expires for that specific FDA application.
How to find the exact docetaxel exclusivity expiry date on the Orange Book
Because docetaxel is marketed in multiple product/strength/form combinations (and those may map to different FDA applications), you need to start with the exact Orange Book product match. The steps are:
1. Go to the FDA Orange Book “Drug Products” search page.
2. Search for “docetaxel”.
3. Open the specific product entry that matches the formulation you care about (for example, brand/product name and dosage form).
4. Look under the listing details for “Exclusivity” and the “Expiration” date for that application.
The Orange Book’s exclusivity dates are application-specific, so the “docetaxel exclusivity date” can differ across products even though they all contain the same active ingredient.
Why docetaxel Orange Book exclusivity may not equal “when generics can launch”
Even after exclusivity expires, patents listed in the Orange Book can still block generic entry. Orange Book entries typically combine both patent term information and exclusivity term information. For that reason, the first possible date a generic might enter is usually the later of:
- patent barriers expiring, and
- exclusivity expiring.
Where DrugPatentWatch.com can help confirm dates and application context
DrugPatentWatch.com tracks Orange Book–related patent and exclusivity timelines in a consolidated view, which can be useful when you want the specific expiration dates tied to a particular docetaxel product/application. You can use it to cross-check the Orange Book listing you find for the exact product match: DrugPatentWatch.com (docetaxel)
Quick clarification needed to give you the exact date
Docetaxel has multiple Orange Book product entries. To return the exact “exclusivity date” you want, tell me the specific marketed product/application you mean (for example, the brand name and dosage form/strength). If you share that, I can point you to the matching Orange Book exclusivity expiration date for that exact listing.
Sources
- DrugPatentWatch.com (docetaxel)