Radicava ORS Generic: When Will Generic Edaravone Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Radicava ORS Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2037 to 2038 A wide window Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last patent end? November 2041 12 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic edaravone is expected to be available between 2037 and 2038. None is for sale yet.
Why 2037 to 2038?
The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. We rate it probable: more likely than not, but it can still move.
If Radicava ORS’s last patent runs to November 2041, how can a generic come sooner?
The 12 patents that run past the expected month, to November 2041 (10,987,341, 11,241,416, 11,478,450, 11,826,352 and 8 more), cover the product’s formulation and a way of using it. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. Here, the companies are expected to settle on a date. Generic companies have been challenging Radicava ORS’s patents with the FDA since April 2023. That is why the expected month comes before the last protection ends. See the road to a generic
Why hasn’t the FDA approved a generic yet?
That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).
Will the generic cost less?
Usually, and more so as more companies sell one. 5 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic. See the price pattern
What should I do now?
Keep taking Radicava ORS as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Radicava ORS by the Numbers
- Reason
- Settlement expectedThe patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- Strong 5 companies have filed, 1 first in line
- Brand sales
- $1.1B a yearBlockbuster
- FDA approved 2022 May 2022 FDA Orange Book
- Patents listed 12 last runs to November 2041 A generic is expected sooner, between 2037 and 2038. See why FDA Orange Book
- Medicare Part D spent $425.6M in 2025, for 3,720 people CMS Part D Spending by Drug
- Medicaid prescriptions 717 in the last four reported quarters, $10.2M CMS Medicaid drug utilization, to Q1 2026
Radicava ORS’s Road to a Generic
Radicava ORS has had the market to itself since the FDA approved it in May 2022 (Shionogi Inc). Its FDA protection (orphan drug) runs to May 2029. Its 12 listed patents run to November 2041. Generic companies have challenged its patents with the FDA since April 2023.
The first generic of Radicava ORS is expected between 2037 and 2038.
Why that month: the patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
Why a Generic Can Come Before November 2041
The last listed patent runs to November 2041, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge. Dr. Brian explains
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Radicava ORS Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Radicava ORS’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 10,987,341 | The product’s formulation | November 2039 | Active |
| 11,241,416 | The product’s formulation | November 2039 | Active |
| 11,478,450 | A way of using it (U-3468) | November 2039 | Active |
| 11,826,352 | The product’s formulation | November 2039 | Active |
| 11,957,660 | The product’s formulation | November 2039 | Active |
| 12,285,409 | The product’s formulation | November 2039 | Active |
| 12,599,586 | The product’s formulation | November 2039 | Active |
| 12,194,025 | A way of using it (U-4111) | November 2041 | Active |
| 12,310,946 | A way of using it (U-4111) | November 2041 | Active |
| 12,478,611 | A way of using it (U-4111) | November 2041 | Active |
| 12,527,769 | A way of using it (U-4111) | November 2041 | Active |
| 12,569,469 | A way of using it (U-4111) | November 2041 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| Orphan drug ODE-144 | Seven years of protection for a use in a rare disease. | May 2029 | Active |
Source: FDA Orange Book, application 215446. Patent numbers open the patent on Google Patents.
Patent Challenges to Radicava ORS
The first patent challenge to Radicava ORS reached the FDA in April 2023, from one company on that first day. The FDA has not approved a first challenger’s generic yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Radicava ORS’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Oral suspension, 105 mg/5 mL | April 2023 | 1 company | No decision yet | Not yet | Not yet | November 2039 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Edaravone
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
5 companies have applied to the FDA to make generic edaravone.
The FDA names a company only once it approves its application, even tentatively, and it has not done that for these yet, so the companies are not named here. Names often come out in the brand company’s patent lawsuits or in the companies’ own announcements.
First in line. One of them was first in line: the first company to challenge the brand’s patents can earn 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Radicava ORS’s patents with the FDA since April 2023: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic edaravone. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic edaravone for sale with the FDA.
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Radicava ORS Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Radicava ORS, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on Radicava ORS
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicare Part D Spending
What Medicare drug plans spent on Radicava ORS, before manufacturer rebates.
- $103.2M
- January to March 2026, the latest CMS has posted
For 2,548 people, about $14,666 per prescription fill - $425.6M
- 2025, the whole year
For 3,720 people, about $14,683 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $103,216,976 | 2,548 | $14,665.67 |
| 2025 | $425,600,013 | 3,720 | $14,683.46 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Radicava ORS only, so no generic is counted in it. What CMS says it is used for: Edaravone is used to treat a certain type of nerve disease called amyotrophic lateral sclerosis (ALS, also commonly called Lou Gehrig's disease). It helps to slow down the worsening of this disease.
Medicaid Prescriptions by Quarter
717 prescriptions in the four quarters to Q1 2026, $10.2M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 172 | $2,490,190 |
| Q4 2025 | 206 | $2,910,875 |
| Q3 2025 | 185 | $2,647,955 |
| Q2 2025 | 154 | $2,183,738 |
| Q1 2025 | 180 | $2,526,160 |
Source: CMS Medicaid State Drug Utilization Data, over Radicava ORS’s own package codes.
Radicava ORS Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 105MG/5ML | Suspension | Oral | May 2022 | Prescription reference product |
Source: FDA Orange Book, Shionogi Inc. Listed for sale today by Mitsubishi Tanabe Pharma America, Inc. and Shionogi Inc. (FDA NDC Directory).
Radicava ORS NDC Codes and Packages
Each Radicava ORS package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 70510-2321-02 | kit | 2 CARTON in 1 CARTON / 1 KIT in 1 CARTON * 1 BOTTLE in 1 KIT / 35 mL in 1 BOTTLE | Shionogi Inc. |
| 70510-2321-02 | kit | 2 CARTON in 1 CARTON / 1 KIT in 1 CARTON * 1 BOTTLE in 1 KIT / 35 mL in 1 BOTTLE | Shionogi Inc. |
| 70510-2322-01 | kit | 1 KIT in 1 CARTON * 50 mL in 1 BOTTLE | Shionogi Inc. |
| 70510-2322-01 | kit | 1 KIT in 1 CARTON * 50 mL in 1 BOTTLE | Shionogi Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Radicava ORS’s own FDA approval (NDA 215446) are listed, never a generic. Some codes belong to companies that repackage Radicava ORS: it is the same medicine in a different package.
What a Generic Radicava ORS Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Radicava ORS as usual. When one arrives, there is nothing you need to sign up for.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Radicava ORS”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Radicava ORS
Is there a generic for Radicava ORS right now?
No. As of October 9, 2026 no generic edaravone is listed for sale in the FDA NDC Directory.
When will Radicava ORS go generic?
2037 to 2038 is the expected window, and that is probable but not certain. The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. The last listed patent runs to November 2041, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic edaravone be the same as Radicava ORS?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. 5 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Radicava ORS?
Not yet. The FDA Orange Book lists no approved generic version of Radicava ORS.
When does the Radicava ORS patent expire?
The FDA Orange Book lists 12 patents for Radicava ORS; the last runs to November 2041. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected window on this page (2037 to 2038) weighs all of that.
Has anyone challenged the Radicava ORS patents?
Yes. The first patent challenge to Radicava ORS reached the FDA in April 2023, from one company on that first day. The FDA has not approved a first challenger’s generic yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
Changes to This Projection
- First generic expected 2037 to 2038 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- Envarsus XRTacrolimus2026 to 2027
- OrenitramTreprostinil DiolamineJune 2027
- StribildCobicistat, Elvitegravir, Emtricitabine, and Tenofovir Disoproxil Fumarate2029 to 2030
- WidaplikAmlodipine, Indapamide, and TelmisartanJanuary 2038
- AuvelityBupropion Hydrochloride and Dextromethorphan HydrobromideSeptember 2038
- JuxtapidLomitapide MesylateJuly 2041
About Radicava ORS
- Generic name edaravone
- How it is taken By mouth
- Company Shionogi Inc
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- Patent challenges Since April 2023 (FDA)
- More drugs Brand-name drugs starting with R
- Have a question? A pharmacist answers, free. Ask about Radicava ORS
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, FDA Paragraph IV Patent Certifications list, CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.