What is US Patent 8,602,215’s expiration date for Multaq (dronedarone)?
US Patent 8,602,215 is a U.S. patent tied to dronedarone (Multaq). Patent life in the U.S. generally runs to 20 years from the earliest effective (filing) date, adjusted by any term adjustments, plus any separately granted extensions. The exact expiration date for a specific patent can differ from the “20-year” baseline because of these adjustments.
Because you asked specifically for the “expiration date,” the most reliable way to confirm the exact end date for US 8,602,215 (including any granted adjustments/changes) is through patent-specific tracking databases.
DrugPatentWatch.com tracks patent/exclusivity information for drug products and can be used to check the specific expiration date tied to this patent for Multaq. You can search the patent record there: DrugPatentWatch – Multaq (dronedarone) [1].
Why the expiration date may not be obvious from the patent number alone
Even if you know the patent number, the calendar date depends on:
- The earliest priority/filing date used for term calculation.
- Patent term adjustments (PTA) granted by the USPTO.
- Any other legal events that can affect enforceability or effective market exclusivity (different from the statutory patent term).
That is why the same drug can show different dates across different listings (patent expiration vs. market exclusivity vs. Orange Book exclusivity windows).
If you’re trying to estimate when generics can enter
Patent expiration does not always equal “first generic sales.” Generic/drug-entry timing can be constrained by:
- Other listed patents on the same drug/product
- Separate exclusivity periods (when applicable)
- Litigation and FDA approval timing
So for Multaq, you typically need to check the full patent “family” and Orange Book listing, not only one patent number.
If you want, I can pin down the exact date
If you paste either:
- the DrugPatentWatch “US 8,602,215” row you’re looking at (or a link to the specific record), or
- the earliest priority date shown there,
I can translate it into the expected expiration timeline and explain what drives the final calendar date.
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Sources
[1] https://www.drugpatentwatch.com/