EXSERVAN Drug Patent Profile

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. Nine 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 29^th, 2003.

Summary for EXSERVAN

International Patents:	162
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	166
Patent Applications:	4,242
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EXSERVAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EXSERVAN
What excipients (inactive ingredients) are in EXSERVAN?	EXSERVAN excipients list
DailyMed Link:	EXSERVAN at DailyMed

See drug prices for EXSERVAN

Pharmacology for EXSERVAN

Drug Class

Benzothiazole

Anatomical Therapeutic Chemical (ATC) Classes for EXSERVAN

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

US Patents and Regulatory Information for EXSERVAN

EXSERVAN is protected by two US patents.

Patents protecting EXSERVAN

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		RX	Yes	Yes			Y
Aquestive	EXSERVAN	riluzole	FILM;ORAL	212640-001	Nov 22, 2019		RX	Yes	Yes			Y

Expired US Patents for EXSERVAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aquestive	EXSERVAN	riluzole	FILM;ORAL	212640-001	Nov 22, 2019
Aquestive	EXSERVAN	riluzole	FILM;ORAL	212640-001	Nov 22, 2019

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

International Patents for EXSERVAN

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

Country	Patent Number	Title	Estimated Expiration
Canada	2468557	EMBALLAGE DESTINE DES COMPOSANTS ELECTRO-OPTIQUES (PACKAGE FOR ELECTRO-OPTICAL COMPONENTS)
European Patent Office	2120897	FILMS À BASE DE POLYMÈRES ET SYSTÈMES DE DÉLIVRANCE DE MÉDICAMENTS FABRIQUÉS À PARTIR DE CEUX-CI (POLYMER-BASED FILMS AND DRUG DELIVERY SYSTEMS MADE THEREFROM)
Denmark	1799453
European Patent Office	3326612	COMPOSITIONS PELLICULAIRES SUBLINGUALES ET BUCCALES (SUBLINGUAL AND BUCCAL FILM COMPOSITIONS)
World Intellectual Property Organization (WIPO)	03046630
Spain	2735512