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Oseni is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are five patents protecting this drug.
This drug has one hundred and seventy-four patent family members in forty-five countries.
The generic ingredient in OSENI is alogliptin benzoate; pioglitazone 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; pioglitazone hydrochloride profile page.
Oseni 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 June 4, 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 OSENI
|Finished Product Suppliers / Packagers:||2|
|Raw Ingredient (Bulk) Api Vendors:||1|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price information for OSENI|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for OSENI|
|What excipients (inactive ingredients) are in OSENI?||OSENI excipients list|
|DailyMed Link:||OSENI at DailyMed|
DrugPatentWatch® Estimated Generic Entry Opportunity Date for OSENI
*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.
Pharmacology for OSENI
Anatomical Therapeutic Chemical (ATC) Classes for OSENI
|Country||Patent Number||Estimated Expiration|
|Denmark||1174135||⤷ Free Forever Trial|
|Costa Rica||10992||⤷ Free Forever Trial|
|World Intellectual Property Organization (WIPO)||2008093882||⤷ Free Forever Trial|
|Eurasian Patent Organization||200970726||⤷ Free Forever Trial|
|Argentina||091289||⤷ Free Forever Trial|
|Germany||122010000020||⤷ Free Forever Trial|
|>Country||>Patent Number||>Estimated Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1084705||C300709||Netherlands||⤷ Free Forever Trial||PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919|
|0861666||07C0006||France||⤷ Free Forever Trial||PRODUCT NAME: PIOGLITAZONE/METFORMINE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/06/354/001 DU 20060728; REGISTRATION NO/DATE AT EEC: EU/1/06/354/001 DU 20060728|
|1586571||1490014-6||Sweden||⤷ Free Forever Trial||PERIOD OF VALIDITY (FROM - UNTIL): 20241222 - 20280922|
|0861666||291||Finland||⤷ Free Forever Trial|
|1084705||C300705||Netherlands||⤷ Free Forever Trial||PRODUCT NAME: SITAGLIPTINE; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321|
|1586571||PA2014011||Lithuania||⤷ Free Forever Trial||PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844 20130919|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|