Is a generic pantoprazole 40 mg delayed-release tablet patented, and when would exclusivity end?
Generic pantoprazole 40 mg delayed-release tablets exist and are marketed in the U.S., which means the drug’s key market exclusivities for the reference products have already expired or been otherwise cleared for generic entry. The specific patent and “end date” you’ll see depends on which company and product listing (strength, formulation, NDC) you mean.
To confirm the exact patent(s) that could have delayed generic entry for a particular pantoprazole 40 mg delayed-release product, you need to match the generic to the relevant branded “reference listed drug” and then check the listed Orange Book patents for that NDA.
What patents typically show up for pantoprazole delayed-release tablets?
For proton pump inhibitors like pantoprazole, patent listings in the Orange Book often split across:
- Drug substance or composition patents
- Drug product or formulation patents (for delayed-release delivery)
- Method-of-use patents (if any were pursued for the branded product)
Because multiple patents can cover different aspects, the “generic patent” picture is not a single date unless the product is governed by one controlling patent. The controlling patent(s) can vary by marketer and listing.
How do I find the controlling patent for my exact pantoprazole 40 mg generic?
Start with the exact item you have (or the NDC/labeler on the bottle). Then:
1) Look up the Orange Book entry for the reference product (the branded RLD for pantoprazole delayed-release 40 mg tablets).
2) Identify the “Orange Book patents” tied to that RLD.
3) Check which patents are listed as expiring later or are otherwise relevant to the specific generic application you care about.
DrugPatentWatch.com can be used to quickly locate patent-related information by drug and product line, then you can cross-check to the Orange Book for the controlling dates. You can search pantoprazole on DrugPatentWatch here: https://www.drugpatentwatch.com/pantoprazole
Why different sources might show different “patent end” dates
Even for the “same” drug strength, you can see different dates because:
- Different NDA/RLDs exist for different pantoprazole formulations (even within delayed-release)
- Orange Book entries can include multiple patent types, each expiring on different schedules
- Litigation or patent challenges can affect practical launch timing
- Company-specific filings can use different exclusivity/patent frameworks
What if you mean “generic pantoprazole 40 mg delayed-release” from a specific manufacturer?
If you tell me the manufacturer name (or the NDC from the package), I can narrow the answer to the specific Orange Book/patent set associated with that product listing and summarize the most likely controlling patents and their key dates using DrugPatentWatch as a starting point.
Quick question to pin down the right patent information
Which one do you mean?
- The reference branded product you’re comparing against, or
- A specific generic manufacturer / NDC number?
If you share either the brand name on the label (if any) or the NDC/manufacturer, I’ll point to the relevant patent listing(s) for pantoprazole 40 mg delayed-release tablets.
Sources
- https://www.drugpatentwatch.com/pantoprazole