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Last Updated: December 4, 2024

EXSERVAN Drug Patent Profile


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Which patents cover Exservan, and what generic alternatives are available?

Exservan is a drug marketed by Aquestive and is included in one NDA. There are two patents protecting this drug.

This drug has one hundred and sixty-two patent family members in nineteen countries.

The generic ingredient in EXSERVAN is riluzole. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the riluzole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Exservan

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

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Summary for EXSERVAN
Drug patent expirations by year for EXSERVAN
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US Patents and Regulatory Information for EXSERVAN

EXSERVAN is protected by two US patents.

Patents protecting EXSERVAN

Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aquestive EXSERVAN riluzole FILM;ORAL 212640-001 Nov 22, 2019 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Aquestive EXSERVAN riluzole FILM;ORAL 212640-001 Nov 22, 2019 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 EXSERVAN

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

International Patents for EXSERVAN

See the table below for patents covering EXSERVAN around the world.

Country Patent Number Title Estimated Expiration
China 100356908 ⤷  Sign Up
Canada 2544776 FILMS A BASE D'OXYDE DE POLYETHYLENE ET SYSTEMES D'ADMINISTRATION DE MEDICAMENTS EN ETANT FAITS (POLYETHYLENE OXIDE-BASED FILMS AND DRUG DELIVERY SYSTEMS MADE THEREFROM) ⤷  Sign Up
European Patent Office 1458367 COUCHES MINCES UNIFORMES SERVANT A DISSOUDRE RAPIDEMENT UNE FORME GALENIQUE INCORPORANT DES COMPOSITIONS DE MASQUAGE DE GOUT (UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM INCORPORATING TASTE-MASKING COMPOSITIONS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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