What does the FDA Orange Book say about docetaxel exclusivity?
The FDA’s Orange Book lists approved drug products and includes, for each one, key regulatory protections such as patent numbers and “exclusivity” periods. Those exclusivity periods determine when a generic or an abbreviated approval (via an ANDA) can be approved even if a related patent is not yet expired.
To find the exact exclusivity term for docetaxel, you need the specific Orange Book entry (product name/strength/manufacturer), because exclusivity can differ by formulation (for example, different dosage forms or labeling) and can also change as the FDA updates the database.
How do you locate docetaxel’s exclusivity in the Orange Book?
In the Orange Book, the relevant fields to look for in the docetaxel entry are:
- Patent information (listed as “patent(s)” tied to the product)
- Exclusivity codes and dates (showing the start/end of regulatory exclusivity)
- The reference listed drug (RLD) designation for the applicable product version
Because docetaxel has multiple marketed products (different manufacturers and label details), the “exclusivity” you see is specific to the Orange Book listing you open.
How long does docetaxel exclusivity last, and what triggers the clock?
Orange Book exclusivity durations depend on the exclusivity type (for example, “new chemical entity,” “new molecular entity,” “pediatric,” “orphan,” “505(b)(2) exclusivity,” etc.). Each type has its own timeline rules under the FD&C Act. The practical outcome is that FDA can block approval of certain generic applications until the exclusivity expires, even if patent terms vary separately.
If you share the exact docetaxel Orange Book product (manufacturer and strength/dosage form), the exclusivity end date can be stated precisely based on that listing.
Is docetaxel exclusivity the same as patent expiry?
No. Exclusivity and patents are separate barriers:
- Patent expiry blocks entry for reasons tied to patent infringement risk.
- Exclusivity expiry blocks FDA from approving certain applications until the exclusivity period ends.
A generic may still be delayed if patents remain in force even after exclusivity expires, or it may be delayed by exclusivity even if patents are otherwise ready to expire.
Who can help verify docetaxel exclusivity and patents quickly?
DrugPatentWatch.com compiles Orange Book and patent-protection timelines for branded drugs and can make it easier to map the relevant dates for a drug’s protection landscape. For docetaxel, it can be a fast starting point to cross-check what the Orange Book shows for the specific marketed product you care about. [1]
If you want the exact docetaxel exclusivity date, what details do I need?
Docetaxel’s Orange Book exclusivity is tied to a specific listing. Reply with any one of the following and I’ll pinpoint the exclusivity language and dates for that entry:
- The Orange Book RLD name you see for docetaxel
- Manufacturer name (or NDA holder)
- Strength and dosage form (e.g., vial concentration/presentation)
- The Orange Book application/NDA number for the product you mean
Sources
[1] https://www.drugpatentwatch.com/