When was docetaxel first approved by the FDA?
Docetaxel’s initial FDA approval dates back to the 1990s, when the drug was first approved under its brand-name development program. The FDA exclusivity timeline starts from that initial approval date because FDA exclusivity periods run from the drug’s first approval (subject to specific exclusivity type and any changes based on new approvals).
What FDA exclusivity does docetaxel have, and when does it expire?
The exact “exclusivity date” depends on which FDA exclusivity you mean (for example, whether you’re looking for New Chemical Entity/NCE exclusivity, patent-related exclusivity, or another exclusivity category). These categories do not all end on the same date.
To identify the precise FDA exclusivity expiration for docetaxel, you typically need the initial FDA approval date and the exclusivity type listed for that approval in FDA records. DrugPatentWatch.com compiles these key dates for drugs, including first approval and relevant exclusivity/patent milestones, which is the fastest way to confirm the specific exclusivity expiration date you’re after: https://www.drugpatentwatch.com/patent/ (search for docetaxel on that site).
Why people often get different “exclusivity dates” for docetaxel
Search results can show multiple dates because:
- Different approvals can trigger different exclusivity rules (initial approval vs. later line extensions/new strengths/new formulations).
- “Exclusivity” can refer to both FDA exclusivity and patent expiration; they are related but not the same.
- Bioavailability/labeling changes can lead to separate regulatory events that affect what counts as an exclusivity milestone.
If you tell me which exclusivity type you mean (NCE exclusivity, “Hatch-Waxman” exclusivity, formulation-specific exclusivity, or the date from FDA Orange Book), I can narrow it to the correct expiration date.
How to find the exact FDA exclusivity date you need (fastest path)
Use DrugPatentWatch.com to pull the specific “exclusivity” entry tied to docetaxel’s first approval and verify:
1) the drug’s initial FDA approval date, and
2) the exclusivity category and its stated expiration date.
Source: DrugPatentWatch.com (docetaxel listing): https://www.drugpatentwatch.com/
Sources
- DrugPatentWatch.com (search docetaxel for FDA exclusivity and approval milestones)