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 three branded drugs marketed by Dr Reddys, Gland Pharma Ltd, Hikma, Long Grove Pharms, Xgen Pharms, and Mitsubishi Tanabe, and is included in seven NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Edaravone has twenty-one patent family members in fourteen countries.
Five suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for edaravone
| International Patents: | 21 |
| US Patents: | 5 |
| Tradenames: | 3 |
| Applicants: | 6 |
| NDAs: | 7 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 157 |
| Clinical Trials: | 57 |
| Patent Applications: | 5,767 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for edaravone |
| 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 |
|---|---|
| Simcere Pharmaceutical Co., Ltd | Phase 3 |
| Xiangya Hospital of Central South University | Phase 3 |
| First Affiliated Hospital of Guangxi Medical University | N/A |
Generic filers with tentative approvals for EDARAVONE
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Xgen Pharms | EDARAVONE | edaravone | SOLUTION;INTRAVENOUS | 217565-002 | Oct 31, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Long Grove Pharms | EDARAVONE | edaravone | SOLUTION;INTRAVENOUS | 218354-001 | May 6, 2024 | AP | RX | No | No | ⤷ 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 | ||||
| Xgen Pharms | EDARAVONE | edaravone | SOLUTION;INTRAVENOUS | 217565-001 | Oct 31, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Gland Pharma Ltd | EDARAVONE | edaravone | SOLUTION;INTRAVENOUS | 216199-001 | May 6, 2024 | AP | RX | No | No | ⤷ 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 edaravone
| 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 edaravone
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Mexico | 2021005144 | SUSPENSION DE EDARAVONA PARA ADMINISTRACION ORAL. (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION.) | ⤷ Sign Up |
| 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) | ⤷ Sign Up |
| China | 112969459 | 用于口服给药的依达拉奉混悬剂 (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION) | ⤷ Sign Up |
| Japan | 2023087011 | 経口投与用エダラボン懸濁剤 (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION) | ⤷ Sign Up |
| Mexico | 2024000663 | SUSPENSION DE EDARAVONA PARA ADMINISTRACION ORAL. (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION.) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2020091036 | ⤷ Sign Up | |
| Australia | 2019369843 | Edaravone suspension for oral administration | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
