Riluzole Patent Expiration

Riluzole was first introduced by Azurity Pharmaceuticals Inc in its drug Rilutek on Dec 12, 1995. Other drugs containing Riluzole are Exservan, Tiglutik Kit. 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.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Tiglutik Kit US8765150 Riluzole aqueous suspensions Mar 12, 2029 Italfarmaco Sa
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)

Azurity



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.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 02 Jan, 2026 US8765150
Payment of Maintenance Fee, 8th Year, Large Entity 03 Jan, 2022 US8765150
Payment of Maintenance Fee, 4th Year, Large Entity 02 Jan, 2018 US8765150
Patent Issue Date Used in PTA Calculation 01 Jul, 2014 US8765150
Recordation of Patent Grant Mailed 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


Riluzole's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Riluzole:

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
Riluzole and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors or Melanoma National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1
Repurposing Riluzole for Cancer-Related Cognitive Impairment: A Pilot Trial University of California, Irvine NA RECRUITING
(Jul 1, 2026)
PHASE2
PHENOGENE-1A (Cromolyn) Treatment in Patients With Mild to Moderate ALS PhenoNet, Inc. NA RECRUITING
(Jul 1, 2026)
PHASE2
Troriluzole in Adult Participants With Spinocerebellar Ataxia Biohaven Pharmaceuticals, Inc. NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE3
A Study to Evaluate the Efficacy and Safety of Adjunctive Troriluzole in Obsessive-Compulsive Disorder Biohaven Pharmaceuticals, Inc. NA COMPLETED
(Apr 1, 2026)
PHASE3
Evaluation the Efficacy and Safety of Mutiple Lenzumestrocel (Neuronata-R® Inj.) Treatment in Patients With ALS Corestemchemon, Inc. NA COMPLETED
(Apr 1, 2026)
PHASE3
A Study to Evaluate the Safety, Efficacy, and Pharmacodynamics of PLL001 in ALS Patients PLL TX AUSTRALIA PTY LTD NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2


Riluzole Generic API Manufacturers

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 Alkem Laboratories Ltd and was approved on Aug 22, 2024.

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