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Kazano is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.
This drug has eighty-seven patent family members in forty countries.
The generic ingredient in KAZANO is alogliptin benzoate; metformin hydrochloride. There are ten drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the alogliptin benzoate; metformin hydrochloride profile page.
Kazano was eligible for patent challenges on January 25, 2017.
By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 24, 2029. This may change due to patent challenges or generic licensing.
There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for KAZANO
|Finished Product Suppliers / Packagers:||2|
|Raw Ingredient (Bulk) Api Vendors:||1|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price information for KAZANO|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for KAZANO|
|What excipients (inactive ingredients) are in KAZANO?||KAZANO excipients list|
|DailyMed Link:||KAZANO at DailyMed|
DrugPatentWatch® Estimated Generic Entry Opportunity Date for KAZANO
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for KAZANO
Identify potential brand extensions & 505(b)(2) entrants
Pharmacology for KAZANO
ATC Classes for KAZANO
|Country||Patent Number||Estimated Expiration|
|Hong Kong||1010484||Get Started Free|
|Canada||2819705||Get Started Free|
|Netherlands||300308||Get Started Free|
|Cyprus||2608||Get Started Free|
|Norway||962606||Get Started Free|
|Germany||04029691||Get Started Free|
|>Country||>Patent Number||>Estimated Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1084705||C01084705/05||Switzerland||Get Started Free||PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 62955 21.11.2013|
|1084705||PA2014043||Lithuania||Get Started Free||PRODUCT NAME: SAXAGLIPTINUM; REGISTRATION NO/DATE: EU/1/09/545/001-015 20091001|
|0896538||91334||Luxembourg||Get Started Free||CERTIFICATE TITLE: SITAGLIPTIN, OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER LE SEL PHOSPHATE (JANUVIA); FIRST REGISTRATION: 20070321|
|0896538||91382||Luxembourg||Get Started Free||91382, EXPIRES: 20220424|
|1084705||PA2014045||Lithuania||Get Started Free||PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919|
|1084705||C300705||Netherlands||Get Started Free||PRODUCT NAME: SITAGLIPTINE; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|