Edaravone Patent Expiration

Edaravone is Used for the treatment of amyotrophic lateral sclerosis (ALS). It was first introduced by Shionogi Inc in its drug Radicava on May 5, 2017. Another drug containing Edaravone is Radicava Ors. 8 different companies have introduced drugs containing Edaravone.


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.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Radicava Ors US12194025 Pharmaceutical composition for oral administration of edaravone and method of administering same Nov 12, 2041 Shionogi
Radicava Ors US12310946 Pharmaceutical composition for oral administration of edaravone and method of administering same Nov 12, 2041 Shionogi
Radicava Ors US12478611 Pharmaceutical Composition For Oral Administration Of Edaravone And Method Of Administering Same Nov 12, 2041 Shionogi
Radicava Ors US12527769 Pharmaceutical Composition For Oral Administration Of Edaravone And Method Of Administering Same Nov 12, 2041 Shionogi
Radicava Ors US12569469 Pharmaceutical Composition For Oral Administration Of Edaravone And Method Of Administering Same Nov 12, 2041 Shionogi
Radicava Ors US10987341 Edaravone suspension for oral administration Nov 01, 2039 Shionogi
Radicava Ors US11241416 Edaravone suspension for oral administration Nov 01, 2039 Shionogi
Radicava Ors US11478450 Edaravone suspension for oral administration Nov 01, 2039 Shionogi
Radicava Ors US11826352 Edaravone suspension for oral administration Nov 01, 2039 Shionogi
Radicava Ors US11957660 Edaravone suspension for oral administration Nov 01, 2039 Shionogi
Radicava Ors US12285409 Edaravone suspension for oral administration Nov 01, 2039 Shionogi
Radicava Ors US12599586 Edaravone Suspension For Oral Administration Nov 01, 2039 Shionogi
Radicava US6933310 Therapeutic agent for amyotrophic lateral sclerosis (ALS) Nov 13, 2020

(Expired)

Shionogi



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.

Given below is the list recent legal activities going on the following patents of Edaravone.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 23 Jul, 2025 US11241416
Patent eCofC Notification 20 May, 2025 US11826352
Email Notification 20 May, 2025 US11826352
Mail Patent eCofC Notification 20 May, 2025 US11826352
Recordation of Patent eCertificate of Correction 20 May, 2025 US11826352
Post Issue Communication - Certificate of Correction 30 Apr, 2025 US11826352
Payment of Maintenance Fee, 4th Year, Large Entity 09 Oct, 2024 US10987341
Mail Patent eGrant Notification 16 Apr, 2024 US11957660
Email Notification 16 Apr, 2024 US11957660
Patent eGrant Notification 16 Apr, 2024 US11957660


Edaravone's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Edaravone:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial Dallas VA Medical Center NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
iPSC-based Drug Repurposing for ALS Medicine (iDReAM) Study Kyoto University NA COMPLETED
(Aug 1, 2026)
PHASE1, PHASE2
Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS Shionogi NA TERMINATED
(Jul 1, 2026)
PHASE3
Safety and Efficacy of Edaravone Dexborneol Sublingual Tablets for Blood-Brain Barrier Dysfunction in CADASIL Huashan Hospital NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
Safety and Pharmacokinetics of MCI-186 in Subjects With Acute Ischemic Stroke Shionogi NA COMPLETED
(Jun 1, 2026)
PHASE2
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment Shionogi NA COMPLETED
(Jun 1, 2026)
PHASE1
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment Shionogi NA COMPLETED
(Jun 1, 2026)
PHASE1
Safety Study of Oral Edaravone Administered in Subjects With ALS Shionogi NA COMPLETED
(Jun 1, 2026)
PHASE3
Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis Shionogi NA COMPLETED
(Jun 1, 2026)
PHASE1
Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy Shionogi NA COMPLETED
(Jun 1, 2026)
PHASE1
Study of Oral Edaravone in Healthy Adult Males Shionogi NA COMPLETED
(Jun 1, 2026)
PHASE1
Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Males (Drug Interaction Study and Preliminary Regimen-Finding Study) Shionogi NA COMPLETED
(Jun 1, 2026)
PHASE1
Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects Shionogi NA COMPLETED
(Jun 1, 2026)
PHASE1
Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS Shionogi NA TERMINATED
(Jun 1, 2026)
PHASE3
Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS) Shionogi NA COMPLETED
(Jun 1, 2026)
PHASE3
Comparative Bioavailability Study of Oral Edaravone Administered Orally and Via a Nasogastric Tube Shionogi NA COMPLETED
(Jun 1, 2026)
PHASE1
Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Subjects (Food Effect Study) Shionogi NA COMPLETED
(Jun 1, 2026)
PHASE1
Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS Shionogi NA COMPLETED
(Jun 1, 2026)
PHASE3
Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS Prilenia NA RECRUITING
(Jun 1, 2026)
PHASE3
Research of Traditional Chinese Medicine Oral Preparation of C. Cicadae in the Treatment of ALS Patients With Elevated Plasma Sphingolipids The Third Xiangya Hospital of Central South University NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
Edaravone Dexborneol for Post-Stroke Epilepsy First Affiliated Hospital of Wenzhou Medical University NA NOT YET RECRUITING
(May 1, 2026)
PHASE3
Evaluate the Efficacy and Safety of Different Doses of Edaravone Dexborneol Concentrated Solution for Injection Combined With Conventional Medical Therapy in the Treatment of Patients With Cerebral Hemorrhage Simcere Pharmaceutical Co., Ltd NA TERMINATED
(Mar 1, 2026)
PHASE2


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 Zydus Pharmaceuticals Usa Inc and was approved on Jul 22, 2026.

Given below is the list of companies who have filed for Edaravone generic, along with the locations of their manufacturing plants worldwide.