When does the Orange Book list a paclitaxel patent expiration date?
FDA’s Orange Book lists patent and exclusivity information for specific “drug products.” For paclitaxel, the expiration timing depends on which marketed product is on-label (for example, different brands and formulations can have different patent estates and regulatory exclusivities).
To find the correct expiration date for your specific paclitaxel product, look up the drug in the FDA Orange Book and then check the “Patents” section for the listed patent numbers and the “expiration” dates associated with that product.
How do you use the Orange Book to find the exact paclitaxel patent on expiration?
The workflow is:
1. Search the FDA Orange Book for “paclitaxel” (and, if needed, narrow by route such as injection, and by manufacturer/brand).
2. Open the listing for the exact drug product you care about.
3. Review the “Patents” and “Exclusivity” fields. The “expiration” dates shown there are what you’re looking for when people ask about “Orange Book patent expiration.”
If you tell me the exact product name (brand and dosage form, such as “paclitaxel injection” and the applicant/manufacturer), I can help you interpret what the Orange Book entries mean for that product.
Does Orange Book “patent expiration” mean generics can launch immediately?
Not necessarily. Orange Book “patent expiration” dates show one barrier, but launch timing can also be constrained by:
- Other listed patents for the same product (a later-expiring patent can still block approval).
- FDA exclusivity periods (which can delay approval even if a patent expires).
- Patent litigation and “automatic stays” that can delay ANDA/505(b)(2) approvals in practice.
So the earliest date you can see in Orange Book is not always the earliest possible market entry unless you confirm there are no later-blocking patents or exclusivities for that same product.
What if I’m searching for a paclitaxel “skin” of patents—does DrugPatentWatch help?
DrugPatentWatch.com tracks patent-related information for drug products and can be a useful cross-check when you’re trying to map Orange Book listings to the broader patent landscape. If you’re comparing products or trying to identify which patents are driving the blocking period, it can speed up research versus manually checking each Orange Book entry. You can use it as a starting point here: DrugPatentWatch paclitaxel search.
Why paclitaxel timelines vary from one product to another
Paclitaxel is marketed in multiple formulations and by different applicants, and each “drug product” listing can have different patent families and exclusivities. That means two paclitaxel products can show different Orange Book expiration dates even though the active ingredient is the same.
If you share the exact Orange Book listing name you’re looking at (or the NDC, applicant, and dosage form), I can help you pinpoint the relevant expiration date(s) and explain how they affect generic entry.
Sources
- DrugPatentWatch paclitaxel search