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Last Updated: April 24, 2024

TIGLUTIK KIT Drug Patent Profile


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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. Nine 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 29th, 2003.

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Drug patent expirations by year for TIGLUTIK KIT
Pharmacology for TIGLUTIK KIT
Drug ClassBenzothiazole
Anatomical Therapeutic Chemical (ATC) Classes for TIGLUTIK KIT
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

Riluzole aqueous suspensions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD OF TREATING AMYOTROPHIC LATERAL SCLEROSIS IN A PATIENT IN NEED OF SUCH TREATMENT, SAID METHOD COMPRISING ADMINISTERING TO SAID PATIENT AN EFFECTIVE AMOUNT OF A SUSPENSION ACCORDING TO CLAIM 1

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for TIGLUTIK KIT

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

Country Patent Number Title Estimated Expiration
Slovenia 2405890 ⤷  Try a Trial
Spain 2400349 ⤷  Try a Trial
Colombia 6410281 SUSPENSIONES ACUOSAS DE RILUZOL ⤷  Try a Trial
Hong Kong 1161985 RILUZOLE AQUEOUS SUSPENSIONS ⤷  Try a Trial
Peru 20120649 SUSPENSIONES ACUOSAS DE RILUZOL ⤷  Try a Trial
Canada 2748856 SUSPENSIONS AQUEUSES DE RILUZOLE (RILUZOLE AQUEOUS SUSPENSIONS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.