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 four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Edaravone has eighteen patent family members in thirteen countries.
One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for edaravone
International Patents: | 18 |
US Patents: | 4 |
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 |
Generic filers with tentative approvals for EDARAVONE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 60mg/100mL | INJECTION;SOLUTION |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Anatomical Therapeutic Chemical (ATC) Classes for edaravone
Paragraph IV (Patent) Challenges for EDARAVONE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
RADICAVA ORS | Oral Suspension | edaravone | 105 mg/5 mL | 215446 | 1 | 2023-04-20 |
US Patents and Regulatory Information for edaravone
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 |
---|---|---|---|
European Patent Office | 3875085 | SUSPENSION D'ÉDARAVONE DESTINÉE À ÊTRE ADMINISTRÉE PAR VOIE ORALE (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION) | ⤷ Try a Trial |
Singapore | 11202104365Q | EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION | ⤷ Try a Trial |
Philippines | 12021550988 | EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION | ⤷ Try a Trial |
Argentina | 116967 | SUSPENSIÓN EDARAVONE PARA ADMINISTRACIÓN ORAL | ⤷ Try a Trial |
South Korea | 20210087490 | 경구 투여용 에다라본 현탁액 | ⤷ Try a Trial |
Japan | 2023087011 | 経口投与用エダラボン懸濁剤 (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION) | ⤷ Try a Trial |
China | 117379369 | 依达拉奉在制备用于治疗肌萎缩侧索硬化的口服混悬剂中的用途 (Application of edaravone in preparation of oral suspension for treating amyotrophic lateral sclerosis) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |