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Edaravone Patent Expiration

Edaravone is Used for the treatment of amyotrophic lateral sclerosis (ALS). It was first introduced by Mitsubishi Tanabe Pharma Corp in its drug Radicava on May 5, 2017. Another drug containing Edaravone is Radicava Ors. 7 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.

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 Mitsubishi Tanabe
Radicava Ors US12310946 Pharmaceutical composition for oral administration of edaravone and method of administering same Nov 12, 2041 Mitsubishi Tanabe
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 Ors US12285409 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.

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

Activity Date Patent Number
Patent litigations
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

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 Sandoz Inc and was approved on Dec 23, 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

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.

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


Manufacturing Plant Locations
New

Gland's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Gland as present at those locations.

Country City Firm Name
India
Hyderabad Gland Pharma Limited
Malur Gland Chemicals Pvt Ltd.
Sriperumbudur Gland Chemical Private Limited
Parawada, Visakhapatnam Gland Pharma Limited
Hyderabad Gland Pharma Limited, Units I+II Pashamylaram Site
Aurangabad Gland Chemical Private Limited
Visakhapatnam Gland Pharma Limited





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
Cherry Hill Hikma Pharmaceuticals USA Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Eatontown Hikma Pharmaceuticals USA, Inc.
Dayton Hikma Injectables USA Inc
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





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. SANDOZ

Sandoz Inc has filed for 1 generic for Edaravone. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
30MG/100ML (0.3MG/ML)

solution Prescription INTRAVENOUS AP Dec 23, 2024


Manufacturing Plant Locations
New

Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.

Country City Firm Name
Austria
Kundl Sandoz GmbH
Langkampfen Sandoz GmbH
United States
East Hanover Sandoz Incorporated
Princeton Sandoz Inc
Spain
Palafolls Sandoz Industrial Products, S.A.
Les Franqueses Del Valles Sandoz Industrial Products S.A.
India
Navi Mumbai Sandoz Private Limited





6. 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
30MG/100ML (0.3MG/ML)

solution Prescription INTRAVENOUS AP Oct 31, 2024
60MG/100ML (0.6MG/ML)

solution Prescription INTRAVENOUS AP Oct 31, 2024