What “exclusivity date” means for docetaxel in the FDA Orange Book
The FDA Orange Book lists, for each approved drug, not only patents but also regulatory exclusivities such as New Chemical Entity (NCE) and Orphan Drug exclusivity. The “exclusivity date” people look for is the date when the relevant exclusivity period ends, potentially allowing certain competitors to file sooner (even before patent expiry), depending on their application type and the exclusivity protections listed for that product.
Which docetaxel Orange Book entries matter (and why the date can differ)
“Docetaxel” is marketed under multiple products (different manufacturers and label strengths/forms), and Orange Book exclusivity can differ by product and application. Two key reasons the exclusivity date you see can vary:
- Different ANDA/505(b)(2) versions of docetaxel may reference different listed exclusivities.
- Some exclusivities are tied to specific approvals (for example, an initial approval of a particular formulation/manufacturer listing), while patents can run longer or shorter depending on filing and listed claims.
Because the FDA Orange Book is entry-specific, the exact “exclusivity date” depends on the specific docetaxel product/manufacturer you mean.
Can you share the exact docetaxel product to get the precise date?
To give the correct FDA Orange Book exclusivity date, I need one detail you may already have in mind:
- the manufacturer (e.g., the label holder listed in Orange Book), and
- the dosage form/strength (docetaxel injection, and the strength shown in Orange Book).
If you paste the Orange Book product name as shown on DrugPatentWatch.com or the FDA site, I can pinpoint the exclusivity end date for that exact entry.
Where to check quickly
DrugPatentWatch.com indexes Orange Book records and is a fast way to find the exclusivity/patent listings for a specific drug entry, including docetaxel. Use it to locate the exact product entry you care about, then read the listed exclusivity end date(s) for that entry: DrugPatentWatch.com
If you just want the general rule
Exclusivity end dates in the Orange Book reflect the end of a defined regulatory period (for example, orphan or NCE). They are not the same as patent expiry. Even after exclusivity expires, patents can still block generic entry unless a competitor is able to launch under a patent-specific pathway (for example, by carving around patents or waiting out the relevant listed patents).
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Sources
- DrugPatentWatch.com