Generic Radicava ORS Availability
Last updated on May 7, 2025.
See also: Generic Radicava
Radicava ORS is a brand name of edaravone, approved by the FDA in the following formulation(s):
RADICAVA ORS (edaravone - suspension;oral)
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Manufacturer: MITSUBISHI TANABE
Approval date: May 12, 2022
Strength(s): 105MG/5ML [RLD]
Is there a generic version of Radicava ORS available?
No. There is currently no therapeutically equivalent version of Radicava ORS available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Radicava ORS. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Edaravone suspension for oral administration
Patent 10,987,341
Issued: April 27, 2021
Inventor(s): Hayama; Tetsuo et al.
Assignee(s): MITSUBISHI TANABE PHARMA CORPORATION (Osaka, JP)An edaravone suspension for human oral administration includes edaravone particles, a dispersant, and water.
Patent expiration dates:
- November 1, 2039✓
- November 1, 2039
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Edaravone suspension for oral administration
Patent 11,241,416
Issued: February 8, 2022
Inventor(s): Hayama Tetsuo & Takahashi Tomohiro & Omura Tomoyuki & Hayashi Kouji & Matsuda Munetomo & Miyazawa Tadashi
Assignee(s): MITSUBISHI TANABE PHARMA CORPORATIONAn edaravone suspension for human oral administration includes edaravone particles, a dispersant, and water.
Patent expiration dates:
- November 1, 2039✓
- November 1, 2039
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Edaravone suspension for oral administration
Patent 11,478,450
Issued: October 25, 2022
Inventor(s): Hayama; Tetsuo et al.
Assignee(s): MITSUBISHI TANABE PHARMA CORPORATION (Osaka, JP)An edaravone suspension for human oral administration includes edaravone particles, a dispersant, and water.
Patent expiration dates:
- November 1, 2039✓
- November 1, 2039
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Edaravone suspension for oral administration
Patent 11,826,352
Issued: November 28, 2023
Inventor(s): Hayama; Tetsuo et al.
Assignee(s): MITSUBISHI TANABE PHARMA CORPORATION (Osaka, JP)An edaravone suspension for human oral administration includes edaravone particles, a dispersant, and water.
Patent expiration dates:
- November 1, 2039✓
- November 1, 2039
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Edaravone suspension for oral administration
Patent 11,957,660
Issued: April 16, 2024
Inventor(s): Hayama; Tetsuo et al.
Assignee(s): MITSUBISHI TANABE PHARMA CORPORATION (Osaka, JP)An edaravone suspension for human oral administration includes edaravone particles, a dispersant, and water.
Patent expiration dates:
- November 1, 2039✓
- November 1, 2039
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Pharmaceutical composition for oral administration of edaravone and method of administering same
Patent 12,194,025
Issued: January 14, 2025
Inventor(s): Shimizu; Hidetoshi et al.
Assignee(s): MITSUBISHI TANABE PHARMA CORPORATION (Osaka, JP)A method of treating an oxidative stress disease includes orally or intragastrically administering, to a subject in need thereof, a pharmaceutical composition including edaravone with a time interval from a consumption of a meal by the subject in need thereof to an administration of the pharmaceutical composition to the subject in need thereof. The time interval is 8 hours or longer after the consumption of a high-fat meal, the time interval is 4 hours or longer after the consumption of a standard meal, or the time interval is 2 hours or longer after the consumption of a light meal.
Patent expiration dates:
- November 12, 2041✓
- November 12, 2041
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Edaravone suspension for oral administration
Patent 12,285,409
Issued: April 29, 2025
Inventor(s): Hayama; Tetsuo et al.
Assignee(s): MITSUBISHI TANABE PHARMA CORPORATION (Osaka, JP)An edaravone suspension for human oral administration includes edaravone particles, a dispersant, and water.
Patent expiration dates:
- November 1, 2039✓
- November 1, 2039
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- May 12, 2025 - NEW PRODUCT
- May 12, 2029 - TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS)
More about Radicava ORS (edaravone)
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- Drug class: miscellaneous central nervous system agents
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
