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 two branded drugs marketed by Mitsubishi Tanabe and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Edaravone has twelve patent family members in twelve countries.
One supplier is listed for this compound.
Summary for edaravone
| International Patents: | 12 |
| US Patents: | 3 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 153 |
| Clinical Trials: | 55 |
| Patent Applications: | 5,762 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in edaravone? | edaravone excipients list |
| DailyMed Link: | edaravone at DailyMed |
Recent Clinical Trials for edaravone
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| First Affiliated Hospital of Guangxi Medical University | N/A |
| Treeway B.V. | Phase 2 |
| NeuroSense Therapeutics Ltd. | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for edaravone
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 ORS | edaravone | SUSPENSION;ORAL | 215446-001 | May 12, 2022 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Mitsubishi Tanabe | RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176-001 | May 5, 2017 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Mitsubishi Tanabe | RADICAVA ORS | edaravone | SUSPENSION;ORAL | 215446-001 | May 12, 2022 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Mitsubishi Tanabe | RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176-001 | May 5, 2017 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >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 | See Plans and Pricing | See Plans and Pricing |
| Mitsubishi Tanabe | RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176-002 | Nov 15, 2018 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for edaravone
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2019369843 | Edaravone suspension for oral administration | See Plans and Pricing |
| South Korea | 20210087490 | 경구 투여용 에다라본 현탁액 | See Plans and Pricing |
| Israel | 282773 | השעיה של edaravone למינהל אוראלי (Edaravone suspension for oral administration) | See Plans and Pricing |
| Taiwan | 202031256 | Edaravone suspension for oral administration | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
