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 four 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.
There is one tentative approval for the generic drug (edaravone), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for RADICAVA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 157 |
Clinical Trials: | 3 |
Patent Applications: | 2,519 |
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 |
Recent Clinical Trials for RADICAVA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Mitsubishi Tanabe Pharma Corporation | Phase 1 |
ALS Canada | Phase 2 |
University of Calgary | 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.
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 | ⤷ 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 | |||
>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 |
---|---|---|---|
Austria | 303808 | ⤷ Try a Trial | |
Japan | 3758164 | ⤷ Try a Trial | |
Japan | WO2002034264 | 筋萎縮性側索硬化症(ALS)治療剤 | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |