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Edaravone - Generic Drug Details
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What are the generic drug sources for edaravone and what is the scope of patent protection?
Edaravone
is the generic ingredient in one branded drug marketed by Mitsubishi Tanabe and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Edaravone has seven patent family members in six countries.
Summary for edaravone
| International Patents: | 7 |
| US Patents: | 1 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 139 |
| Clinical Trials: | 35 |
| Patent Applications: | 2,730 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | edaravone at DailyMed |
Recent Clinical Trials for edaravone
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ruijin Hospital | Phase 2 |
| Auzone Biological Technology Pty Ltd | Phase 1 |
| CMAX Clinical Research Pty Ltd | Phase 1 |
US Patents and Regulatory Information for edaravone
| 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 | Start Trial | Start Trial | Start Trial | ||||
| Mitsubishi Tanabe | RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176-002 | Nov 15, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Mitsubishi Tanabe | RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176-001 | May 5, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Mitsubishi Tanabe | RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176-001 | May 5, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Mitsubishi Tanabe | RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176-002 | Nov 15, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start 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 edaravone
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mitsubishi Tanabe | RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176-001 | May 5, 2017 | Start Trial | Start Trial |
| Mitsubishi Tanabe | RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176-002 | Nov 15, 2018 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for edaravone
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | WO2002034264 | Start Trial |
| Austria | 303808 | Start Trial |
| Spain | 2248144 | Start Trial |
| European Patent Office | 1405637 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0234264 | Start Trial |
| Germany | 60022560 | Start Trial |
| Japan | 3758164 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
