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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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: | 2,522 |
| 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 |
|---|---|
| Auzone Biological Technology Pty Ltd | Phase 1 |
| Mitsubishi Tanabe Pharma Corporation | Phase 1 |
| Brain Canada | 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.
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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