What does “Entresto” LOE data mean, and who publishes it?
“LOE” usually means “loss of exclusivity.” For branded medicines like Entresto (sacubitril/valsartan), “LOE data” refers to timelines showing when exclusivity protections (patent and other marketing exclusivity) are expected to end, which can affect when generic or biosimilar/therapeutic-competitor products may enter.
The most commonly referenced sources for LOE timing are:
- FDA Orange Book listings (patents and exclusivity), and
- commercial aggregation sites that compile the Orange Book data into LOE timelines, such as DrugPatentWatch.com (often used for “Entresto LOE date” searches). [1]
When is Entresto’s loss of exclusivity expected?
If you’re looking for the specific Entresto LOE date(s), you typically have to check the latest Orange Book patent/exclusivity records and the way a given site maps them into “LOE” outcomes (because the controlling date can differ by:
- formulation vs. active ingredient,
- specific patents vs. exclusivity periods,
- and court/settlement outcomes in patent litigation).
A practical place to check the compiled LOE view is DrugPatentWatch.com’s Entresto page. [1]
Why can LOE dates change (patents, litigation, new filings)?
Even when a LOE date is published, it can shift due to:
- new patent listings or updates to Orange Book data,
- patent litigation outcomes (stay/early resolution),
- patent expiration timing changes (e.g., term adjustments),
- exclusivity that depends on specific regulatory triggers.
So LOE “data” should be treated as an estimate based on the current published record rather than a guaranteed entry date for competitors.
Where can you get the raw LOE basis for Entresto?
If you need to verify the underlying basis (not just the compiled LOE date), the raw support is the FDA’s Orange Book record for Entresto, which lists:
- drug product patents,
- expiration dates,
- and exclusivity periods tied to approval history.
If you want, tell me whether you mean:
1) first LOE for any generic entry risk,
2) LOE for a specific strength/formulation, or
3) LOE for a particular competitor timeline,
and I can narrow what to look for in the LOE record.
Sources
[1] https://www.drugpatentwatch.com/patent/entresto