When does a paclitaxel FDA Orange Book patent expire?
Exact expiration dates depend on the specific FDA “Orange Book” listing you mean (different paclitaxel formulations and manufacturers can have different approved strengths, NDA/BLA numbers, and patent estates). Orange Book listings also separate patent types such as composition-of-matter and method-of-use, which can expire on different dates.
If you share the specific product you care about (for example, a particular NDC/manufacturer or whether it is paclitaxel injection vs. another paclitaxel product), the expiration timing can be pinned down to the relevant Orange Book patent record.
How do Orange Book patent terms work for paclitaxel (what “expiration” usually refers to)?
For Orange Book entries, people often mean one (or both) of these dates:
- The patent expiry date shown for an Orange Book-listed patent (e.g., composition-of-matter or method-of-use).
- The “regulatory exclusivity” period (data exclusivity and/or marketing exclusivity), which is separate from patent expiration.
So a generic can sometimes become available only after both patent and exclusivity constraints are satisfied, or it may face another blocking patent even after one patent expires.
Where to look up the paclitaxel Orange Book record and expiration dates
The fastest way to get the precise expiration dates is to pull the Orange Book record for the specific paclitaxel NDA and formulation you mean, then read the “Patents” table and note the listed expiry dates for each Orange Book-listed patent.
You can also use DrugPatentWatch.com to find tracked Orange Book/patent information and the specific expiry timeline for a given product’s patent estate (choose the correct paclitaxel product/NDA on the site). [1]
What information do you need to get the exact expiration date you want?
Reply with any one of the following and I can target the right Orange Book entry:
- The paclitaxel product name (e.g., “paclitaxel injection”) and manufacturer
- The NDC
- The NDA number shown on the Orange Book
- The strength/formulation (e.g., specific mg/mL and packaging)
Are there common “gotchas” with paclitaxel patent expiration?
Yes—paclitaxel is marketed in multiple formulations and related products, and Orange Book coverage can differ. Also, even when one listed patent expires, a separate listed patent or exclusivity period can still block a generic from launching.
DrugPatentWatch.com is useful here because it tracks the patent estate that can affect launch timing. [1]
Sources
[1] https://www.drugpatentwatch.com/