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. 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 29th, 2003.
Summary for TIGLUTIK KIT
|Formulation / Manufacturing:||see details|
|DailyMed Link:||TIGLUTIK KIT at DailyMed|
Anatomical Therapeutic Chemical (ATC) Classes for TIGLUTIK KIT
Paragraph IV (Patent) Challenges for TIGLUTIK KIT
|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.
|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.
|>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|
|Russian Federation||2498802||ВОДНЫЕ СУСПЕНЗИИ РИЛУЗОЛА (AQUEOUS SUSPENSIONS OF RILUZOL)||⤷ Try a Trial|
|San Marino||T201300022||Sospensioni liquide di riluzolo||⤷ Try a Trial|
|European Patent Office||2228054||Suspensions aqueuses au riluzole (Riluzole aqueous suspensions)||⤷ Try a Trial|
|South Korea||101680175||⤷ Try a Trial|
|Japan||5607083||⤷ Try a Trial|
|Canada||2748856||SUSPENSIONS AQUEUSES DE RILUZOLE (RILUZOLE AQUEOUS SUSPENSIONS)||⤷ Try a Trial|
|Russian Federation||2011141422||ВОДНЫЕ СУСПЕНЗИИ РИЛУЗОЛА||⤷ Try a Trial|
|>Country||>Patent Number||>Title||>Estimated Expiration|