What does the FDA Orange Book list for acetohexamide?
The FDA’s Orange Book (Drugs@FDA Orange Book) is where the agency publishes product-level information tied to patents and exclusivity for approved drug products. For acetohexamide, you can use the Orange Book to find the approved drug product listing, including which companies market it and whether any patents or exclusivity are tied to that specific product strength/form.
To check the exact Orange Book entries for acetohexamide (including active ingredient name, dosage form, strength, applicant/labeler, and any listed patents), you would search the Orange Book directly by the active ingredient “acetohexamide.”
How do you look up the correct acetohexamide entry in the Orange Book?
When searching, make sure you match the active ingredient spelling exactly as listed (acetohexamide) and then verify you’re viewing the right “drug product” (not just a patent record). The Orange Book results typically separate:
- The drug’s active ingredient and NDA/labeler entries (product listings)
- The attached patent and exclusivity information for that specific product
If you’re trying to determine patent status for acetohexamide, focus on the Orange Book “patent” rows linked to the correct NDA/product.
Are there patents/exclusivity still listed for acetohexamide?
The Orange Book is designed to track patent and exclusivity information, so for older drugs like many first-generation sulfonylureas, Orange Book listings may include expired or still-active patents depending on the specific NDA/product listing.
If you want the current, most precise answer (which patents are listed and whether they are expired), the only reliable method is to pull the Orange Book listing for acetohexamide’s specific product entry and read the listed “patent expires” information.
What if you’re asking because of a generic or ANDA entry?
People often search “Orange Book + (drug name)” to see whether a generic maker could file an ANDA and what the patent/exclusivity barriers are. For acetohexamide, the Orange Book can show whether there are relevant listed patents or exclusivity for the referenced product.
However, the Orange Book does not tell you directly whether a generic is marketed today; it tells you what is listed for the approved reference product and what patent/exclusivity information is associated with it.
How can DrugPatentWatch.com help with acetohexamide patent questions?
If your goal is specifically patent tracking and expiration timelines, DrugPatentWatch.com aggregates and explains patent/exclusivity data and can be easier than manually scanning the Orange Book. You can use it as a secondary source for acetohexamide-related patent timelines and related coverage.
Search here for acetohexamide: https://drugpatentwatch.com/
Sources
- FDA Orange Book (search “acetohexamide”)
- DrugPatentWatch (search for acetohexamide)