RILUZOLE - Generic Drug Details

What are the generic drug sources for riluzole and what is the scope of freedom to operate?

Riluzole is the generic ingredient in four branded drugs marketed by Aquestive, Alkem Labs Ltd, Italfarmaco Sa, Covis, Apotex Corp, Daito Pharms Co Ltd, Glenmark Pharms Ltd, Impax Labs, Kenton, Mylan Pharms Inc, and Sun Pharm Inds Ltd, and is included in twelve NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Riluzole has one hundred and eighty-seven patent family members in twenty-nine countries.

There are nine drug master file entries for riluzole. Seven suppliers are listed for this compound.

Summary for RILUZOLE

International Patents:	187
US Patents:	3
Tradenames:	4
Applicants:	11
NDAs:	12
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	130
Patent Applications:	6,711
Drug Prices:	Drug price trends for RILUZOLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RILUZOLE
What excipients (inactive ingredients) are in RILUZOLE?	RILUZOLE excipients list
DailyMed Link:	RILUZOLE at DailyMed

See drug prices for RILUZOLE

Recent Clinical Trials for RILUZOLE

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

Sponsor	Phase
University of Sydney	Phase 2/Phase 3
FightMND	Phase 2/Phase 3
Mario Negri Institute for Pharmacological Research	Phase 2/Phase 3

See all RILUZOLE clinical trials

Pharmacology for RILUZOLE

Drug Class

Benzothiazole

Medical Subject Heading (MeSH) Categories for RILUZOLE

Anticonvulsants

Excitatory Amino Acid Antagonists

Neuroprotective Agents

Anatomical Therapeutic Chemical (ATC) Classes for RILUZOLE

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

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
Kenton	RILUZOLE	riluzole	TABLET;ORAL	206045-001	Dec 9, 2019	AB	RX	No	No
Italfarmaco Sa	TIGLUTIK KIT	riluzole	SUSPENSION;ORAL	209080-001	Sep 5, 2018	AB	RX	Yes	Yes			Y
Sun Pharm Inds Ltd	RILUZOLE	riluzole	TABLET;ORAL	091417-001	Jun 18, 2013	AB	RX	No	No
Glenmark Pharms Ltd	RILUZOLE	riluzole	TABLET;ORAL	091394-001	Jun 18, 2013	AB	RX	No	No
Alkem Labs Ltd	RILUZOLE	riluzole	TABLET;ORAL	204048-001	Mar 30, 2016	AB	RX	No	Yes
Aquestive	EXSERVAN	riluzole	FILM;ORAL	212640-001	Nov 22, 2019		DISCN	Yes	No			Y
Mylan Pharms Inc	RILUZOLE	riluzole	TABLET;ORAL	203042-001	Jul 1, 2013	AB	RX	No	No

Expired US Patents for RILUZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aquestive	EXSERVAN	riluzole	FILM;ORAL	212640-001	Nov 22, 2019
Covis	RILUTEK	riluzole	TABLET;ORAL	020599-001	Dec 12, 1995
Aquestive	EXSERVAN	riluzole	FILM;ORAL	212640-001	Nov 22, 2019

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

International Patents for RILUZOLE

Country	Patent Number	Title	Estimated Expiration
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)
Denmark	1799453
Canada	2748856	SUSPENSIONS AQUEUSES DE RILUZOLE (RILUZOLE AQUEOUS SUSPENSIONS)
Japan	5160229
European Patent Office	2405890	SUSPENSIONS AQUEUSES DE RILUZOLE (RILUZOLE AQUEOUS SUSPENSIONS)
Spain	2444951
Canada	2621263	FILMS UNIFORMES POUR DOSAGE POSOLOGIQUE A DISSOLUTION RAPIDECOMPRENANT DES COMPOSITIONS ANTIADHERENTES (UNIFORM FILMS FOR RAPID-DISSOLVE DOSAGE FORM INCORPORATING ANTI-TACKING COMPOSITIONS)