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Riluzole Patent Expiration

Riluzole was first introduced by Covis Pharma Gmbh in its drug Rilutek on Dec 12, 1995. Other drugs containing Riluzole are Tiglutik Kit, Exservan. 11 different companies have introduced drugs containing Riluzole.


Riluzole Patents

Given below is the list of patents protecting Riluzole, 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
Exservan US8603514 Uniform films for rapid dissolve dosage form incorporating taste-masking compositions Apr 03, 2024

(Expired)

 Aquestive
Exservan US8765167 Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions Feb 20, 2024

(Expired)

 Aquestive
Rilutek US5527814 Use of 2-amino-6-(trifluoromethoxy)benzothiazole for obtaining a medicament for the treatment of amyotrophic lateral sclerosis Jun 18, 2013

(Expired)

 Covis
Tiglutik Kit US8765150 Riluzole aqueous suspensions Mar 12, 2029 Italfarmaco Sa


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 Riluzole's patents.

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

Event Date Patent/Publication
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 03 Jan, 2022 US8765150
Payment of Maintenance Fee, 4th Year, Large Entity 02 Jan, 2018 US8765150
Recordation of Patent Grant Mailed 01 Jul, 2014 US8765150
Patent Issue Date Used in PTA Calculation 01 Jul, 2014 US8765150
Email Notification 12 Jun, 2014 US8765150
Issue Notification Mailed 11 Jun, 2014 US8765150
Dispatch to FDC 29 May, 2014 US8765150
Mail Miscellaneous Communication to Applicant 27 May, 2014 US8765150
Printer Rush- No mailing 27 May, 2014 US8765150
Email Notification 27 May, 2014 US8765150



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Riluzole Generics

Several generic applications have been filed for Riluzole. The first generic version for Riluzole was by Impax Laboratories Inc and was approved on Jan 29, 2003. And the latest generic version is by Kenton Chemicals And Pharmaceuticals Corp and was approved on Dec 9, 2019.

Given below is the list of companies who have filed for Riluzole generic.


1. APOTEX CORP

Apotex Corp has filed for 1 generic for Riluzole. Given below are the details of the strengths of this generic introduced by Apotex Corp.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Discontinued ORAL N/A Jun 18, 2013


2. MYLAN PHARMS INC

Mylan Pharmaceuticals Inc has filed for 1 generic for Riluzole. Given below are the details of the strengths of this generic introduced by Mylan Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Prescription ORAL AB Jul 1, 2013


3. IMPAX LABS

Impax Laboratories Inc has filed for 1 generic for Riluzole. Given below are the details of the strengths of this generic introduced by Impax Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Prescription ORAL AB Jan 29, 2003


4. SUN PHARM INDS LTD

Sun Pharmaceutical Industries Ltd has filed for 1 generic for Riluzole. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Prescription ORAL AB Jun 18, 2013


5. DAITO PHARMS CO LTD

Daito Pharmaceuticals Co Ltd has filed for 1 generic for Riluzole. Given below are the details of the strengths of this generic introduced by Daito Pharms Co Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Discontinued ORAL N/A Oct 16, 2018


6. KENTON

Kenton Chemicals And Pharmaceuticals Corp has filed for 1 generic for Riluzole. Given below are the details of the strengths of this generic introduced by Kenton.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Prescription ORAL AB Dec 9, 2019


7. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 1 generic for Riluzole. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG

(reference standard)

tablet Prescription ORAL AB Mar 30, 2016


8. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 1 generic for Riluzole. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Prescription ORAL AB Jun 18, 2013