TIGLUTIK KIT Drug Patent Profile

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

Tiglutik Kit is a drug marketed by Italfarmaco Sa and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-five patent family members in twenty-one countries.

The generic ingredient in TIGLUTIK KIT 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 Tiglutik Kit

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

Summary for TIGLUTIK KIT

International Patents:	25
US Patents:	1
Applicants:	1
NDAs:	1
Formulation / Manufacturing:	see details
DailyMed Link:	TIGLUTIK KIT at DailyMed

Anatomical Therapeutic Chemical (ATC) Classes for TIGLUTIK KIT

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

Paragraph IV (Patent) Challenges for TIGLUTIK KIT

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 TIGLUTIK KIT

TIGLUTIK KIT is protected by one US patents.

Patents protecting TIGLUTIK KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Italfarmaco Sa	TIGLUTIK KIT	riluzole	SUSPENSION;ORAL	209080-001	Sep 5, 2018		RX	Yes	Yes			Y

EU/EMA Drug Approvals for TIGLUTIK KIT

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 TIGLUTIK KIT

See the table below for patents covering TIGLUTIK KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2498802	ВОДНЫЕ СУСПЕНЗИИ РИЛУЗОЛА (AQUEOUS SUSPENSIONS OF RILUZOL)
San Marino	T201300022	Sospensioni liquide di riluzolo
European Patent Office	2228054	Suspensions aqueuses au riluzole (Riluzole aqueous suspensions)
South Korea	101680175
Japan	5607083
Canada	2748856	SUSPENSIONS AQUEUSES DE RILUZOLE (RILUZOLE AQUEOUS SUSPENSIONS)
Russian Federation	2011141422	ВОДНЫЕ СУСПЕНЗИИ РИЛУЗОЛА