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Last Updated: March 29, 2024

RILUZOLE Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Riluzole

A generic version of RILUZOLE was approved as riluzole by IMPAX LABS on January 29th, 2003.

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Drug patent expirations by year for RILUZOLE
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Recent Clinical Trials for RILUZOLE

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SponsorPhase
InFlectis BioSciencePhase 2
NeuroSense Therapeutics Ltd.Phase 2
University of UtahPhase 2

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Pharmacology for RILUZOLE
Drug ClassBenzothiazole
Medical Subject Heading (MeSH) Categories for RILUZOLE
Paragraph IV (Patent) Challenges for RILUZOLE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TIGLUTIK KIT Oral Suspension riluzole 50 mg/10 mL 209080 1 2021-03-12

US Patents and Regulatory Information for RILUZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alkem Labs Ltd RILUZOLE riluzole TABLET;ORAL 204048-001 Mar 30, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Pharms Inc RILUZOLE riluzole TABLET;ORAL 203042-001 Jul 1, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glenmark Pharms Ltd RILUZOLE riluzole TABLET;ORAL 091394-001 Jun 18, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Inds Ltd RILUZOLE riluzole TABLET;ORAL 091417-001 Jun 18, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex Corp RILUZOLE riluzole TABLET;ORAL 091300-001 Jun 18, 2013 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Daito Pharms Co Ltd RILUZOLE riluzole TABLET;ORAL 204430-001 Oct 16, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for RILUZOLE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Sanofi Mature IP Rilutek riluzole EMEA/H/C/000109
Rilutek is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).Clinical trials have demonstrated that Rilutek extends survival for patients with ALS.Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free.There is no evidence that Rilutek exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms.Rilutek has not been shown to be effective in the late stages of ALS.Safety and efficacy of Rilutek has only been studied in ALS. Therefore, Rilutek should not be used in patients with any other form of motor-neurone disease.
Authorised no no no 1996-06-10
Zentiva k.s. Riluzole Zentiva riluzole EMEA/H/C/002622
Riluzole Zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).Clinical trials have demonstrated that Riluzole Zentiva extends survival for patients with ALS. Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free.There is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. Riluzole Zentiva has not been shown to be effective in the late stages of ALS.Safety and efficacy of Riluzole Zentiva has only been studied in ALS. Therefore, Riluzole Zentiva should not be used in patients with any other form of motor-neurone disease.
Authorised no no no 2012-05-07
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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