Prescription medicine
Edaravone Brand names: Radicava
Edaravone (Radicava) is a prescription medicine with an FDA approval on record since 2017. FDA's NDC Directory lists it from 3 generic labelers.
- Generic listed
Check it at the source: the edaravone FDA label on DailyMed (effective May 7, 2024, Gland Pharma Limited); the NDA 209176 record on Drugs@FDA; every edaravone label on DailyMed.
Highlights of the record
FDA label of May 7, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageEdaravone injection is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Forms and strengths
- 30 mg/100ml
- 60 mg/100ml
Injection (solution); kit; injection.
On the market
- Earliest approval on file
- May 5, 2017 Radicava, Shionogi; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 7 first May 6, 2024; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 3 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- November 12, 2041 Radicava Ors oral suspension; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,540 through July 30, 2026
What is edaravone used for?
From the label: indications and usageEdaravone injection is indicated for the treatment of amyotrophic lateral sclerosis (ALS). Edaravone injection is indicated for the treatment of amyotrophic lateral sclerosis (ALS)
Source: FDA drug label (edaravone), Gland Pharma Limited, effective May 7, 2024 (SPL set 46452eb5-db17-400d-b25b-11844a11e711), via openFDA; the full label on DailyMed
Is there a generic for edaravone (Radicava)?
The FDA approved the first generic edaravone on May 6, 2024. 7 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists edaravone from 3 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 12 patents for Radicava Ors oral suspension, the last expiring on November 12, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2024 first generic approved
- 2041 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for edaravone?
The FDA Adverse Event Reporting System holds 1,540 reports that list edaravone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 438 are coded as a death and 394 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Edaravone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other