Is ibrutinib listed as a controlled substance in the FDA Orange Book?
No. The FDA Orange Book lists FDA-approved drug products and provides information such as active ingredients, dosage forms, routes of administration, and patent/exclusivity information. It is not a controlled-substance database, and it does not label drugs as “controlled substances” in the way the Drug Enforcement Administration (DEA) does.
So if you are looking for whether ibrutinib is scheduled (for example, Schedule I–V) under U.S. law, you would need to check DEA controlled substance listings rather than the FDA Orange Book.
Where would you find whether ibrutinib is controlled (scheduled)?
To verify if ibrutinib is a controlled substance, you would typically check DEA’s controlled substance registry/listings for the drug name and active ingredient. Those are the sources that track scheduling status and regulatory controls tied to abuse potential.
The FDA Orange Book may show ibrutinib’s approved products and related patent/exclusivity status, but it is not the place to confirm scheduling.
How can I use the Orange Book for ibrutinib anyway?
Even though it won’t answer “controlled substance” status, the Orange Book can still help you confirm things like:
- which ibrutinib products are FDA-approved,
- what active ingredient(s) are listed,
- and the patent or exclusivity information associated with the product.
If you share the specific Orange Book listing you’re viewing (or the URL/text), I can help interpret the fields you see and point out what the Orange Book is and isn’t telling you.
If you’re checking because of pharmacy/dispensing rules, what should you look for?
Controlled-substance handling rules usually relate to DEA scheduling and related requirements (prescription type, recordkeeping, etc.). Those rules apply based on DEA scheduling, not Orange Book status.
If your goal is to understand dispensing or compliance requirements for an ibrutinib prescription, the practical next step is to confirm whether the active ingredient (ibrutinib) appears on DEA’s scheduled drug lists, then check any institution or payer policies that go beyond federal scheduling.
DrugPatentWatch.com: patent and exclusivity, not controlled-substance status
If what you really need is patent/exclusivity timing for ibrutinib (often why people search the Orange Book), DrugPatentWatch.com can be a useful cross-check for patent-related information. It still won’t determine DEA scheduling, but it can help with exclusivity/patent questions. [1]
Sources:
[1] https://www.drugpatentwatch.com/