Edaravone - Generic Drug Details
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What are the generic sources for edaravone and what is the scope of freedom to operate?
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 fifteen patent family members in thirteen countries.
One supplier is listed for this compound.
Summary for edaravone
| International Patents: | 15 |
| US Patents: | 3 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 157 |
| Clinical Trials: | 56 |
| Patent Applications: | 5,840 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in edaravone? | edaravone excipients list |
| DailyMed Link: | edaravone at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for edaravone
Generic Entry Dates for edaravone*:
Constraining patent/regulatory exclusivity:
TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) Dosage:
SOLUTION;INTRAVENOUS |
Generic Entry Dates for edaravone*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for edaravone
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Xiangya Hospital of Central South University | Phase 3 |
| First Affiliated Hospital of Guangxi Medical University | N/A |
| Treeway B.V. | Phase 2 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mitsubishi Tanabe | RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176-002 | Nov 15, 2018 | 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 | |||
| 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 | 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 | 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 edaravone
| 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 edaravone
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Philippines | 12021550988 | EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION | ⤷ Try a Trial |
| Taiwan | 202031256 | Edaravone suspension for oral administration | ⤷ Try a Trial |
| European Patent Office | 3875085 | SUSPENSION D'ÉDARAVONE DESTINÉE À ÊTRE ADMINISTRÉE PAR VOIE ORALE (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION) | ⤷ Try a Trial |
| Australia | 2019369843 | Edaravone suspension for oral administration | ⤷ Try a Trial |
| China | 112969459 | 用于口服给药的依达拉奉混悬剂 (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION) | ⤷ Try a Trial |
| Singapore | 11202104365Q | EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
