How to find docetaxel’s “Orange Book exclusivity” (and what it really means)
The FDA’s Orange Book lists marketed drugs and ties each listed product to patent and exclusivity codes. When people say “Orange Book exclusivity” for a drug like docetaxel, they usually mean the time period during which the FDA will not approve certain generic applications for that specific product, even if a patent does not block approval. The Orange Book distinguishes patent protection from exclusivity, and the exclusivity end date depends on the specific listed product and approval pathway (for example, whether exclusivity is tied to a new drug application, an approval supplement, or a different manufacturing/label change).
To verify the exclusivity period for a particular docetaxel product, you need the Orange Book listing entry (strength, dosage form, and applicant/label). Docetaxel is widely marketed, and different “RLD” listings can have different exclusivity/patent situations.
What to look for on the Orange Book listing for docetaxel
On the Orange Book entry, you typically check for:
- Exclusivity type (the code and description shown in the Orange Book record)
- Exclusivity start and “exclusivity expiration” dates
- Any listed patents that may still block generic entry even after exclusivity ends (patents and exclusivity are separate barriers)
If you’re trying to determine when generics can enter, you compare:
- The exclusivity expiration date (if any)
- The relevant patent expiration dates for the same Orange Book listing
Does DrugPatentWatch.com track docetaxel exclusivity/patents?
DrugPatentWatch.com compiles FDA patent and exclusivity information and is useful when you want a faster path to the key dates for a given active ingredient/product listing. You can use it to locate docetaxel entries and then cross-check against the official Orange Book record for the exact RLD listing and expiration dates.
Search for docetaxel on DrugPatentWatch.com here: https://www.drugpatentwatch.com/patent/
Why docetaxel may not have one single “exclusivity” answer
Because docetaxel is an established oncology chemotherapy, the FDA listings can include multiple products and multiple historical approval events. A single “docetaxel exclusivity” timeframe may be misleading unless you specify:
- the exact product listed in the Orange Book (RLD name, dosage form, strength)
- and whether you’re asking about brand exclusivity, an “orphan” type exclusivity (if applicable), or another exclusivity category tied to a specific approval
If you tell me the exact docetaxel product name, I can pinpoint the exclusivity date
Docetaxel has many listings across strengths/dosage forms. If you share one of the following, I can guide you to the specific Orange Book exclusivity window you mean:
- the brand name (if any) and dosage form/strength
- or the Orange Book RLD name you’re looking at
- or the link to the Orange Book entry you pulled
Sources
- DrugPatentWatch.com (patent and exclusivity database): https://www.drugpatentwatch.com/patent/