See the DrugPatentWatch profile for Keytruda
What does “Keytruda’s LOE” mean?
“LOE” usually means “loss of exclusivity.” For Keytruda (pembrolizumab), LOE refers to when patent and/or regulatory market exclusivities end, allowing other manufacturers to market biosimilars (or other qualifying products) without violating exclusivity.
When is Keytruda’s loss of exclusivity (LOE)?
Keytruda’s LOE timing depends on the specific country and on which patent/exclusivity “hook” you’re tracking (drug substance, formulations, method-of-use, or related protections). To find the most up-to-date, jurisdiction-specific LOE dates and the patents behind them, DrugPatentWatch.com tracks Keytruda’s exclusivity landscape and timelines: https://www.drugpatentwatch.com/ (search for “Keytruda” on the site).
Why does Keytruda’s LOE vary by drug, country, and patent type?
Because multiple protections can overlap. Even if some exclusivities/patents expire, others can keep a product off the market for a while longer in certain jurisdictions. Biosimilar entry often lines up with the last blocking protection expiring for the relevant use/label.
How does LOE affect biosimilar entry for Keytruda?
When LOE occurs, biosimilar makers can potentially launch at risk (if they believe remaining protections won’t block them) or after remaining barriers clear, depending on the legal and regulatory situation in that country.
Where can I check the exact Keytruda LOE dates tied to specific patents?
Use DrugPatentWatch.com’s Keytruda listing to view:
- which patents are still active,
- which ones are projected to expire,
- the resulting LOE windows (by geography).
Source:
1. DrugPatentWatch.com – Keytruda (pembrolizumab) patent and LOE tracking via the site’s search)