What Mounjaro (tirzepatide) patent listings are shown in the FDA Orange Book?
You can view the FDA Orange Book patent entries for Mounjaro by searching for the active ingredient tirzepatide (and the listed brand name Mounjaro). The Orange Book typically lists the submitted patent numbers tied to the drug product, including patents that cover things like the active ingredient, formulations, methods of use, and related exclusivity details.
To get the exact patent numbers “listed” for Mounjaro, use the Orange Book search interface:
- FDA Orange Book (search “Mounjaro” or “tirzepatide”): https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
Which “Orange Book” fields matter when you’re looking for patents?
When you open the Mounjaro entry in the Orange Book, the patent-related information is usually shown with fields such as:
- Patent number
- Patent expiration date
- Patent “type”/category (the Orange Book uses code/type groupings for what the patent covers)
- Whether the patent is tied to drug substance vs. drug product vs. method-of-use
These are the fields that determine when others may be able to file (and when they may be able to market generics/biosimilars, depending on the product type and regulatory pathway).
How can DrugPatentWatch help confirm Mounjaro (tirzepatide) exclusivity/patent timelines?
If you want a second, more consolidated view of the same patent landscape (often easier to scan than the Orange Book page), DrugPatentWatch tracks branded drug patents and their expiry dates. You can use it to cross-check the Orange Book listings and follow related litigation/filings where available.
- DrugPatentWatch – Mounjaro / tirzepatide: https://www.drugpatentwatch.com/
If you tell me your goal, I can point you to the right Orange Book patents
The Orange Book can show multiple patents and expiration dates. To make the results useful, tell me what you need, for example:
- “I need only the Orange Book patents expiring first”
- “I need method-of-use patents”
- “I need the drug substance vs. drug product patents”
- “I need the latest listed patents and their expiration dates”
If you share the Orange Book page text (or the patent numbers you see), I can also help you interpret the listing categories and what they imply for potential generic entry timing.
Sources
- https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
- https://www.drugpatentwatch.com/