EDARAVONE Drug Patent Profile
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When do Edaravone patents expire, and what generic alternatives are available?
Edaravone is a drug marketed by Dr Reddys, Gland Pharma Ltd, Hikma, and Long Grove Pharms. and is included in four NDAs.
The generic ingredient in EDARAVONE 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 Edaravone
A generic version of EDARAVONE was approved as edaravone by DR REDDYS on May 6th, 2024.
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Questions you can ask:
- What is the 5 year forecast for EDARAVONE?
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- What is Average Wholesale Price for EDARAVONE?
Summary for EDARAVONE
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 157 |
| Clinical Trials: | 57 |
| Patent Applications: | 2,541 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EDARAVONE |
| 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dr Reddys | EDARAVONE | edaravone | SOLUTION;INTRAVENOUS | 215917-001 | May 6, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | EDARAVONE | edaravone | SOLUTION;INTRAVENOUS | 215508-001 | May 6, 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 | |||
| Gland Pharma Ltd | EDARAVONE | edaravone | SOLUTION;INTRAVENOUS | 216199-002 | May 6, 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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
