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 five patents protecting this drug.
The generic ingredient in RADICAVA is edaravone. Four suppliers are listed for this compound. Additional details are available on the edaravone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Radicava
A generic version of radicava was approved as edaravone by DR REDDYS on May 6th, 2024.
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Questions you can ask:
- What is the 5 year forecast for radicava?
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- What is Average Wholesale Price for radicava?
Summary for radicava
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 157 |
Clinical Trials: | 4 |
Patent Applications: | 2,519 |
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 |
---|---|
Auzone Biological Technology Pty Ltd | Phase 1 |
Mitsubishi Tanabe Pharma Corporation | Phase 1 |
University of Calgary | Phase 2 |
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: ⤷ Sign Up
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: ⤷ Sign Up
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 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Mitsubishi Tanabe | RADICAVA ORS | edaravone | SUSPENSION;ORAL | 215446-001 | May 12, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Mitsubishi Tanabe | RADICAVA ORS | edaravone | SUSPENSION;ORAL | 215446-001 | May 12, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Mitsubishi Tanabe | RADICAVA ORS | edaravone | SUSPENSION;ORAL | 215446-001 | May 12, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Mitsubishi Tanabe | RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176-002 | Nov 15, 2018 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Japan | 3758164 | ⤷ Sign Up | |
Spain | 2248144 | ⤷ Sign Up | |
Germany | 60022560 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 0234264 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |