RADICAVA Drug Patent Profile
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Which patents cover Radicava, and what generic alternatives are available?
Radicava is a drug marketed by Mitsubishi Tanabe and is included in two NDAs. There are three patents protecting this drug.
The generic ingredient in RADICAVA is edaravone. One supplier is listed for this compound. Additional details are available on the edaravone profile page.
DrugPatentWatch® Generic Entry Outlook for Radicava
Radicava was eligible for patent challenges on May 5, 2021.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 5, 2024. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for RADICAVA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 155 |
Clinical Trials: | 3 |
Patent Applications: | 2,575 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for RADICAVA |
What excipients (inactive ingredients) are in RADICAVA? | RADICAVA excipients list |
DailyMed Link: | RADICAVA at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for RADICAVA
Generic Entry Date for RADICAVA*:
Constraining patent/regulatory exclusivity:
TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) NDA:
Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for RADICAVA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Mitsubishi Tanabe Pharma Corporation | Phase 1 |
Brain Canada | Phase 2 |
ALS Canada | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for RADICAVA
US Patents and Regulatory Information for RADICAVA
RADICAVA is protected by zero US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of RADICAVA is ⤷ Try a Trial.
This potential generic entry date is based on TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS).
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
FDA Regulatory Exclusivity protecting RADICAVA
TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS)
Exclusivity Expiration: ⤷ Try a Trial
FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mitsubishi Tanabe | RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176-001 | May 5, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mitsubishi Tanabe | RADICAVA ORS | edaravone | SUSPENSION;ORAL | 215446-001 | May 12, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Mitsubishi Tanabe | RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176-002 | Nov 15, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mitsubishi Tanabe | RADICAVA ORS | edaravone | SUSPENSION;ORAL | 215446-001 | May 12, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mitsubishi Tanabe | RADICAVA ORS | edaravone | SUSPENSION;ORAL | 215446-001 | May 12, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for RADICAVA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Mitsubishi Tanabe | RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176-001 | May 5, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
Mitsubishi Tanabe | RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176-002 | Nov 15, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for RADICAVA
See the table below for patents covering RADICAVA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 60022560 | ⤷ Try a Trial | |
Spain | 2248144 | ⤷ Try a Trial | |
Japan | WO2002034264 | 筋萎縮性側索硬化症(ALS)治療剤 | ⤷ Try a Trial |
Austria | 303808 | ⤷ Try a Trial | |
European Patent Office | 1405637 | MEDICAMENTS POUR TRAITER LA SCLEROSE LATERALE AMYOTROPHIQUE (SLA) (REMEDIES FOR AMYOTROPHIC LATERAL SCLEROSIS (ALS)) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |