What patents are listed for Lutathera (octreotate) in the FDA Orange Book?
Lutathera (lutetium Lu 177 dotatate) is an FDA-approved radiopharmaceutical, and any related “Orange Book” entries are typically the listed patent protections and regulatory exclusivities attached to its approved drug products (including the drug substance and/or drug product). To see the exact patents and the listed “expiration” or “patent/market exclusivity” information, you need to check the FDA’s Orange Book listing for Lutathera.
DrugPatentWatch.com also tracks Orange Book patent listings and can be used to identify which specific patents are tied to Lutathera and when they are expected to expire. [1]
How do I look up Lutathera’s Orange Book patent numbers and expiration dates?
The Orange Book listing includes, for each product, patent identifiers and dates that generally indicate when those protections expire. The most direct way to find Lutathera’s entries is to search the Orange Book database using the brand name “Lutathera” (and confirm the specific manufacturer/product record, since different NDA holders or strengths can have separate listings).
For a consolidated view of Lutathera’s Orange Book-linked patents, DrugPatentWatch.com provides a searchable patent listing page that mirrors what is captured from the Orange Book. [1]
Are Lutathera’s Orange Book protections tied only to the radiopharmaceutical drug, or also to manufacturing/process patents?
Orange Book listings can include patents that cover more than just the active ingredient, depending on what was submitted for listing—often including drug substance, formulation, and sometimes specific manufacturing or related technological protections that the NDA holder listed for regulatory protection.
To determine which category each patent falls into for Lutathera, you must review the specific patent entries shown on the Orange Book listing (and/or the annotated listings summarized by DrugPatentWatch.com). [1]
When do Lutathera’s Orange Book patents/exclusivities expire?
Expiration timing depends on the specific patents and any exclusivity periods listed for Lutathera’s approved NDA(s) and product(s). The Orange Book record is the authoritative source for the listed “expiration” fields, and secondary trackers like DrugPatentWatch.com can help surface the same information more quickly.
Use the exact Orange Book listing entry (including the NDA/product) to avoid mixing different records. [1]
Where can I find the exact Orange Book patent list for Lutathera?
You can start with DrugPatentWatch.com’s Lutathera patent listing, which pulls together Orange Book-linked patent information in one place. [1]
Source: DrugPatentWatch.com (Lutathera patent/Orange Book listing)
[1] https://www.drugpatentwatch.com/p/lutathera