RILUTEK Drug Patent Profile

Which patents cover Rilutek, and when can generic versions of Rilutek launch?

Rilutek is a drug marketed by Covis and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rilutek

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

Summary for RILUTEK

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	166
Clinical Trials:	31
Patent Applications:	4,188
Drug Prices:	Drug price information for RILUTEK
What excipients (inactive ingredients) are in RILUTEK?	RILUTEK excipients list
DailyMed Link:	RILUTEK at DailyMed

See drug prices for RILUTEK

Recent Clinical Trials for RILUTEK

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Ning Jin	Phase 1
Corestem, Inc.	Phase 3
Zambon SpA	Phase 1

See all RILUTEK clinical trials

US Patents and Regulatory Information for RILUTEK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Covis	RILUTEK	riluzole	TABLET;ORAL	020599-001	Dec 12, 1995		DISCN	Yes	No

Expired US Patents for RILUTEK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	RILUTEK	riluzole	TABLET;ORAL	020599-001	Dec 12, 1995

EU/EMA Drug Approvals for RILUTEK

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 RILUTEK

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0558861
Hungary	217130	Eljárás 2-amino-6-(trifluor-metoxi)-benzotriazolt (riluzolt) tartalmazó, a motoneuron megbetegedéseinek kezelésére szolgáló gyógyszerkészítmények előállítására (PROCESS FOR PREPARING PHARMACEUTICAL COMPOSITIONS CONTAINING 2-AMINO 6--TRIFLUOROMETHOXY BENZOTHIAZOLE (RILUZOLE) USEFUL IN THE TREATMENT OF MOTOR NEURON DISEASES)
European Patent Office	0627919	APPLICATION DE L'AMINO-2 TRIFLUOROMETHOXY-6 BENZOTHIAZOLE (RILUZOLE) POUR OBTENIR UN MEDICAMENT DESTINE AU TRAITEMENT DES MALADIES DU MOTONEURONE (APPLICATION OF 2-AMINO 6-TRIFLUOROMETHOXY BENZOTHIAZOLE (RILUZOLE) FOR OBTAINING A DRUG USEFUL IN THE TREATMENT OF MOTOR NEURON DISEASES)
Russian Federation	2110260	AGENT FOR TREATMENT OF LATERAL AMYOTROPHIC SCLEROSIS