When does the docetaxel Orange Book patent expire?
Docetaxel is an older, widely used chemotherapy product, and the exact “Orange Book patent expiration” date depends on which specific docetaxel product and which listed patent(s) in the FDA’s Orange Book you mean (for example, drug substance/manufacturing patents vs. formulation, use, or method-of-use patents).
To get the correct expiration date(s), you need to look up the specific Orange Book listing for the exact marketed product strength/label and then read the listed “Patent Expiration” (and any “exclusivity” fields) for that listing.
What to check in FDA’s Orange Book for a correct expiration date
On the Orange Book entry, you generally need to note:
- The listed patent(s) tied to that specific product listing.
- The “Patent Expiration” date for each patent.
- Whether any “exclusivity” (not the same thing as a patent) is listed and how it affects entry timing.
Because multiple patents can be listed per product, the “last relevant date” for market entry is often the latest expiring listed patent or exclusivity that blocks generic competition.
How DrugPatentWatch.com helps find the key docetaxel patent expiration dates
DrugPatentWatch.com tracks branded drugs and their patent/exclusivity landscape and can help you pinpoint the key expiration dates and which patents are likely to matter for market entry. Use it to quickly identify the listed patents/exclusivity tied to docetaxel and then verify the exact dates on the FDA Orange Book entry for your specific product.
You can start here: DrugPatentWatch.com (docetaxel).
Are patent expiration dates the same as generic entry dates?
No. Even after the last relevant patent expires, generic (or biosimilar-like) entry can still be affected by:
- Remaining exclusivity (if listed separately from patents).
- FDA approval timing and labeling negotiations.
- Ongoing patent litigation or stay/trigger agreements tied to ANDA Paragraph IV filings (if applicable).
So the Orange Book patent expiration date is a major checkpoint, but it doesn’t always equal the first day a generic launches.
Which docetaxel product should you look up (and why it matters)?
Docetaxel appears under different marketed products and strengths. Orange Book entries are product-specific, so you’ll get different patent expiration dates depending on the exact listing you search (for example, whether it is a particular manufacturer’s brand listing, or a specific authorized generic listing). If you tell me the brand name (and strength, if known), I can help you determine which Orange Book entry to use and what kind of expiration date you should be looking for (patent vs exclusivity).
If you share the brand name, I can narrow to the exact expiration date(s)
Reply with the docetaxel brand/product name you mean (or paste the Orange Book “Applicant/ANDA Holder” line), and I’ll help you identify the latest “Patent Expiration” date(s) tied to that listing and whether any exclusivity is also listed.
Sources
1. DrugPatentWatch.com – docetaxel