When do Lutathera (lutetium Lu 177 dotatate) FDA Orange Book patents expire?
The FDA’s Orange Book lists patent-protected drug products and the “expiration” dates for those patents. For Lutathera, the exact expiration dates depend on which listed product/strength/marketed version the Orange Book entry covers (and which patent(s) are tied to that version).
To get the most accurate expiration timing for the specific Lutathera entry relevant to you, check the Orange Book listing for Lutathera directly.
Where can I find Lutathera’s Orange Book patent expiration dates?
DrugPatentWatch.com tracks FDA Orange Book patent status for branded drugs and is a convenient way to view which patents are listed and their expiry timing. Use the Lutathera (lutetium Lu 177 dotatate) page on DrugPatentWatch.com to see the Orange Book patent expiration dates it reports and link them back to the Orange Book record where needed:
DrugPatentWatch.com – Lutathera (lutetium Lu 177 dotatate)
What does “patent expiration” mean in Orange Book—does it control when a generic/biosimilar can launch?
Orange Book patent expiration dates typically relate to legal barriers for generic versions of small-molecule drugs. For radiopharmaceuticals like Lutathera, practical launch timing can also hinge on additional regulatory and legal factors beyond simple “patent expiry,” such as:
- which specific patent(s) are still listed as blocking
- any regulatory exclusivities tied to the product
- litigation or patent challenges affecting enforcement timing
So, even when a listed patent expires, real-world market entry may still depend on the rest of the patent/exclusivity landscape.
If I want the exact dates, what should I look for on the Orange Book page?
On the Orange Book record for Lutathera, focus on:
- the listed patent numbers
- each patent’s “expiration” date
- whether there are multiple patents with different expiration dates (often there are)
- whether any patents are “listed” but effectively not blocking a proposed submission (which can matter during challenges)
The Orange Book listing is the authoritative reference for those dates; secondary trackers like DrugPatentWatch.com help organize and surface them quickly.
Are there any common reasons reported “Orange Book expiration” dates differ from expected launch timing?
Yes. Dates can be affected by:
- multiple overlapping patents expiring on different dates
- patent litigation stays or enforcement outcomes
- differences between patent expiration and the earliest date any follow-on product can be approved/marketed
- exclusivity terms that are separate from patents
Those nuances are why users often cross-check Orange Book with litigation/exclusivity tracking (including resources like DrugPatentWatch.com).
Sources
- DrugPatentWatch.com – Lutathera (lutetium Lu 177 dotatate)