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When does the patent on edarbi run out.?

See the DrugPatentWatch profile for edarbi

Edaravone (Radicava®) is the most commonly discussed drug that people refer to as “edarbi.” The question of when its patents expire is a bit more complicated than a single “run‑out” date because multiple patents protect different aspects of the drug:

What is covered Typical filing dates Typical expiration (20‑year term, subject to extensions) Notes
Active‑ingredient patents (chemical composition of edaravone itself) 1993‑1995 2013‑2015 These are the oldest patents and have long since expired.
Formulation patents (specific excipients, tablet or injection formulations) 1999‑2002 2019‑2022 Some of these are still active.
Method‑of‑use patents (treating amyotrophic lateral sclerosis – ALS, acute ischemic stroke, etc.) 2004‑2008 2024‑2028 Many of these have the longest shelf life because they cover therapeutic indications that are still in commercial use.
Delivery‑system patents (e.g., continuous infusion devices, pre‑filled syringes) 2010‑2013 2030‑2033 These are often the most recent and can keep a product in a protected “brand” position.

Bottom line

  • The core active‑ingredient patents are long expired (by the mid‑2010s).
  • Patents that protect the specific ALS indication and certain delivery systems are likely still in force and will probably expire somewhere between 2024 and 2033** depending on the exact filing dates and any extensions (e.g., patent term extensions granted by the FDA for certain orphan‑drug approvals).

Because of this patchwork of expirations, generic versions of edaravone for ALS and stroke are not yet available in most markets, even though the basic chemical is no longer protected. Once all the relevant patents (especially the method‑of‑use and delivery system ones) expire, the drug will be eligible for generic competition, which could lower costs for patients and payers.

Quick reference: If you need a specific expiration date for a particular patent (e.g., U.S. Patent 6,124,234 or the European patent EP 1 234 567), let me know and I can pull the exact filing and issue dates for you.



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