Edaravone Patent Expiration
Edaravone is Used for the treatment of amyotrophic lateral sclerosis (ALS). It was first introduced by Mitsubishi Tanabe Pharma Corp
Edaravone Patents
Given below is the list of patents protecting Edaravone, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Radicava Ors | US10987341 | Edaravone suspension for oral administration | Nov 01, 2039 | Mitsubishi Tanabe |
| Radicava Ors | US11241416 | Edaravone suspension for oral administration | Nov 01, 2039 | Mitsubishi Tanabe |
| Radicava Ors | US11478450 | Edaravone suspension for oral administration | Nov 01, 2039 | Mitsubishi Tanabe |
| Radicava Ors | US11826352 | Edaravone suspension for oral administration | Nov 01, 2039 | Mitsubishi Tanabe |
| Radicava Ors | US11957660 | Edaravone suspension for oral administration | Nov 01, 2039 | Mitsubishi Tanabe |
| Radicava | US6933310 | Therapeutic agent for amyotrophic lateral sclerosis (ALS) |
Nov 13, 2020
(Expired) | Mitsubishi Tanabe |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Edaravone's patents.
Latest Legal Activities on Edaravone's Patents
Given below is the list recent legal activities going on the following patents of Edaravone.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Recordation of Patent Grant Mailed Critical | 16 Apr, 2024 | US11957660 |
| Patent eGrant Notification | 16 Apr, 2024 | US11957660 |
| Email Notification Critical | 16 Apr, 2024 | US11957660 |
| Mail Patent eGrant Notification | 16 Apr, 2024 | US11957660 |
| Recordation of Patent eGrant | 16 Apr, 2024 | US11957660 |
| Patent Issue Date Used in PTA Calculation Critical | 16 Apr, 2024 | US11957660 |
| Email Notification Critical | 28 Mar, 2024 | US11957660 |
| Issue Notification Mailed Critical | 27 Mar, 2024 | US11957660 |
| Dispatch to FDC | 21 Mar, 2024 | US11957660 |
| Application Is Considered Ready for Issue Critical | 21 Mar, 2024 | US11957660 |
Edaravone's Family Patents
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Edaravone Generic API Manufacturers
Several generic applications have been filed for Edaravone. The first generic version for Edaravone was by Gland Pharma Ltd and was approved on May 6, 2024. And the latest generic version is by Xgen Pharmaceuticals Djb Inc and was approved on Oct 31, 2024.
Given below is the list of companies who have filed for Edaravone generic, along with the locations of their manufacturing plants worldwide.
1. DR REDDYS
Dr Reddys Laboratories Ltd has filed for 1 generic for Edaravone. Given below are the details of the strengths of this generic introduced by Dr Reddys.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 60MG/100ML (0.6MG/ML) | solution | Prescription | INTRAVENOUS | AP | May 6, 2024 |
2. GLAND PHARMA LTD
Gland Pharma Ltd has filed for 2 different strengths of generic version for Edaravone. Given below are the details of the strengths of this generic introduced by Gland Pharma Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 30MG/100ML (0.3MG/ML) | solution | Prescription | INTRAVENOUS | AP | May 6, 2024 |
| 60MG/100ML (0.6MG/ML) | solution | Prescription | INTRAVENOUS | AP | May 6, 2024 |
3. HIKMA
Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Edaravone. Given below are the details of the strengths of this generic introduced by Hikma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 30MG/100ML (0.3MG/ML) | solution | Prescription | INTRAVENOUS | AP | May 6, 2024 |
Manufacturing Plant Locations New
Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.
| Country | City | Firm Name | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| Portugal |
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| Jordan |
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4. LONG GROVE PHARMS
Long Grove Pharmaceuticals Llc has filed for 1 generic for Edaravone. Given below are the details of the strengths of this generic introduced by Long Grove Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 30MG/100ML (0.3MG/ML) | solution | Prescription | INTRAVENOUS | AP | May 6, 2024 |
5. XGEN PHARMS
Xgen Pharmaceuticals Djb Inc has filed for 2 different strengths of generic version for Edaravone. Given below are the details of the strengths of this generic introduced by Xgen Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 60MG/100ML (0.6MG/ML) | solution | Prescription | INTRAVENOUS | AP | Oct 31, 2024 |
| 30MG/100ML (0.3MG/ML) | solution | Prescription | INTRAVENOUS | AP | Oct 31, 2024 |