RADICAVA ORS Drug Patent Profile
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Which patents cover Radicava Ors, and when can generic versions of Radicava Ors launch?
Radicava Ors is a drug marketed by Mitsubishi Tanabe and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-one patent family members in fourteen countries.
The generic ingredient in RADICAVA ORS is edaravone. Four suppliers are listed for this compound. Additional details are available on the edaravone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Radicava Ors
A generic version of RADICAVA ORS was approved as edaravone by DR REDDYS on May 6th, 2024.
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Summary for RADICAVA ORS
| International Patents: | 21 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 4 |
| Drug Prices: | Drug price information for RADICAVA ORS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RADICAVA ORS |
| DailyMed Link: | RADICAVA ORS at DailyMed |
Recent Clinical Trials for RADICAVA ORS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Auzone Biological Technology Pty Ltd | Phase 1 |
| Mitsubishi Tanabe Pharma Corporation | Phase 1 |
| Brain Canada | Phase 2 |
Paragraph IV (Patent) Challenges for RADICAVA ORS
| 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 RADICAVA ORS
RADICAVA ORS is protected by five US patents and two FDA Regulatory Exclusivities.
Patents protecting RADICAVA ORS
Edaravone suspension for oral administration
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Edaravone suspension for oral administration
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting RADICAVA ORS
TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS)
Exclusivity Expiration: ⤷ Sign Up
NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ 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 | ⤷ Sign Up | ||||
| Mitsubishi Tanabe | RADICAVA ORS | edaravone | SUSPENSION;ORAL | 215446-001 | May 12, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for RADICAVA ORS
When does loss-of-exclusivity occur for RADICAVA ORS?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 6967
Patent: SUSPENSIÓN EDARAVONE PARA ADMINISTRACIÓN ORAL
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 19369843
Patent: Edaravone suspension for oral administration
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2021008197
Patent: suspensão de edaravone para administração oral
Estimated Expiration: ⤷ Sign Up
China
Patent: 2969459
Patent: 用于口服给药的依达拉奉混悬剂 (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION)
Estimated Expiration: ⤷ Sign Up
Patent: 7379369
Patent: 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)
Estimated Expiration: ⤷ Sign Up
Patent: 7379370
Patent: 用于口服给药的依达拉奉混悬剂 (Edaravone suspension for oral administration)
Estimated Expiration: ⤷ Sign Up
Patent: 7398346
Patent: 用于口服给药的依达拉奉混悬剂 (Edaravone suspension for oral administration)
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 75085
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 75085
Patent: SUSPENSION D'ÉDARAVONE DESTINÉE À ÊTRE ADMINISTRÉE PAR VOIE ORALE (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 2773
Patent: השעיה של edaravone למינהל אוראלי (Edaravone suspension for oral administration)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 2020091036
Patent: 経口投与用エダラボン懸濁剤
Estimated Expiration: ⤷ Sign Up
Patent: 74502
Estimated Expiration: ⤷ Sign Up
Patent: 23087011
Patent: 経口投与用エダラボン懸濁剤 (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION)
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 21005144
Patent: SUSPENSION DE EDARAVONA PARA ADMINISTRACION ORAL. (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION.)
Estimated Expiration: ⤷ Sign Up
Patent: 23009973
Patent: SUSPENSION DE EDARAVONA PARA ADMINISTRACION ORAL. (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION.)
Estimated Expiration: ⤷ Sign Up
Patent: 24000663
Patent: SUSPENSION DE EDARAVONA PARA ADMINISTRACION ORAL. (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION.)
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 021550988
Patent: EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 202104365Q
Patent: EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 210087490
Patent: 경구 투여용 에다라본 현탁액
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 2031256
Patent: Edaravone suspension for oral administration
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering RADICAVA ORS around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Mexico | 2024000663 | SUSPENSION DE EDARAVONA PARA ADMINISTRACION ORAL. (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION.) | ⤷ Sign Up |
| European Patent Office | 3875085 | SUSPENSION D'ÉDARAVONE DESTINÉE À ÊTRE ADMINISTRÉE PAR VOIE ORALE (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION) | ⤷ Sign Up |
| Denmark | 3875085 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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