~ Buy the OSENI (alogliptin benzoate; pioglitazone hydrochloride) Drug Profile, 2024 PDF Report in the Report Store ~

OSENI Drug Patent Profile

✉ Email this page to a colleague

Which patents cover Oseni, and what generic alternatives are available?

Oseni is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and one patent family members in forty-two 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.

DrugPatentWatch^® Generic Entry Outlook for Oseni

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 five 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

< Available with Subscription >

Sign Up

AI Research Assistant

Questions you can ask:

What is the 5 year forecast for OSENI?
What are the global sales for OSENI?
What is Average Wholesale Price for OSENI?

Summary for OSENI

International Patents:	101
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	29
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

Drug patent expirations by year for OSENI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OSENI

Generic Entry Date for OSENI^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 022426 Dosage: TABLET;ORAL

^*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

Drug Class	Dipeptidyl Peptidase 4 Inhibitor Peroxisome Proliferator Receptor alpha Agonist Peroxisome Proliferator Receptor gamma Agonist Thiazolidinedione
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors Peroxisome Proliferator-activated Receptor alpha Agonists Peroxisome Proliferator-activated Receptor gamma Agonists

US Patents and Regulatory Information for OSENI

OSENI is protected by four US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of OSENI is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting OSENI

Dipeptidyl peptidase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN

Dipeptidyl peptidase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN

Dipeptidyl peptidase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Solid preparation comprising alogliptin and pioglitazone
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-004	Jan 25, 2013		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-002	Jan 25, 2013		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-003	Jan 25, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-005	Jan 25, 2013		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-004	Jan 25, 2013		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-006	Jan 25, 2013		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-002	Jan 25, 2013		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for OSENI

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-004	Jan 25, 2013	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-002	Jan 25, 2013	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-005	Jan 25, 2013	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-002	Jan 25, 2013	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-006	Jan 25, 2013	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-002	Jan 25, 2013	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-006	Jan 25, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for OSENI

When does loss-of-exclusivity occur for OSENI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 5097
Patent: PREPARACION SOLIDA
Estimated Expiration: ⤷ Sign Up

Australia

Patent: 08211981
Patent: Solid preparation comprising alogliptin and pioglitazone
Estimated Expiration: ⤷ Sign Up

Austria

Patent: 88227
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 0807453
Patent: PREPARAÇÃO SÓLIDA
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 77201
Patent: PREPARATION SOLIDE COMPRENANT DE L'ALOGLIPTINE ET DE LA PIOGLITAZONE (SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE)
Estimated Expiration: ⤷ Sign Up

Chile

Patent: 08000279
Patent: COMPOSICION FARMACEUTICA SOLIDA QUE COMPRENDE UNA PARTE QUE COMPRENDE 2-((6-(3R)-3-AMINO-1-PIPERIDINIL)3,4-DIHIDRO-3-METIL-2,4-DIOXO-1-(2H)-PIRIMIDIN)METIL)BENZONITRILO, AZUCAR O ALCOHOL DE AZUCAR Y UNA SEGUNDA PARTE QUE COMPRENDE PIOGLITAZONA Y AZUC
Estimated Expiration: ⤷ Sign Up

China

Patent: 1646420
Patent: Solid preparation comprising alogliptin and pioglitazone
Estimated Expiration: ⤷ Sign Up

Costa Rica

Patent: 992
Patent: PREPARACION SOLIDA QUE COMPRENDE ALOGLIPTINA Y PIOGLITAZONA
Estimated Expiration: ⤷ Sign Up

Croatia

Patent: 0110094
Estimated Expiration: ⤷ Sign Up

Cyprus

Patent: 11264
Estimated Expiration: ⤷ Sign Up

Denmark

Patent: 07905
Estimated Expiration: ⤷ Sign Up

Dominican Republic

Patent: 009000195
Patent: PREPARACION SOLIDA QUE COMPRENDE ALOGLIPTINA Y PIOGLITAZONA CINASAS
Estimated Expiration: ⤷ Sign Up

Ecuador

Patent: 099608
Patent: PREPARACION SOLIDA QUE COMPRENDE ALOGLIPTINA Y PIOGLITAZONA
Estimated Expiration: ⤷ Sign Up

Eurasian Patent Organization

Patent: 5180
Patent: ТВЕРДЫЙ ПРЕПАРАТ, СОДЕРЖАЩИЙ АЛОГЛИПТИН И ПИОГЛИТАЗОН (SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE)
Estimated Expiration: ⤷ Sign Up

Patent: 0970726
Patent: ТВЕРДЫЙ ПРЕПАРАТ, СОДЕРЖАЩИЙ АЛОГЛИПТИН И ПИОГЛИТАЗОН
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 07905
Patent: PRÉPARATION SOLIDE COMPRENANT DE L'ALOGLIPTINE ET DE LA PIOGLITAZONE (SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE)
Estimated Expiration: ⤷ Sign Up

Georgia, Republic of

Patent: 0125410
Patent: SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE
Estimated Expiration: ⤷ Sign Up

Germany

Patent: 2008003522
Estimated Expiration: ⤷ Sign Up

Hong Kong

Patent: 38188
Patent: SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 0108
Patent: SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 84968
Estimated Expiration: ⤷ Sign Up

Patent: 10517937
Estimated Expiration: ⤷ Sign Up

Jordan

Patent: 50
Patent: مستحضر صلب (Solid Preparation)
Estimated Expiration: ⤷ Sign Up

Malaysia

Patent: 7596
Patent: SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 09008100
Patent: PREPARACION SOLIDA QUE COMPRENDE ALOGLIPTINA Y PIOGLITAZONA. (SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE.)
Estimated Expiration: ⤷ Sign Up

Montenegro

Patent: 239
Patent: ČVRSTI PREPARAT KOJI SADRŽI ALOGLIPTIN I PIOGLITAZON (SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE)
Estimated Expiration: ⤷ Sign Up

Morocco

Patent: 169
Patent: إعداد متين يحتوي على الالوكليبتين و البيوجليتازون.
Estimated Expiration: ⤷ Sign Up

New Zealand

Patent: 9008
Patent: SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE
Estimated Expiration: ⤷ Sign Up

Peru

Patent: 081663
Patent: PREPARACION SOLIDA QUE COMPRENDE ALOGLIPTIN Y PIOGLITAZONA
Estimated Expiration: ⤷ Sign Up

Poland

Patent: 07905
Estimated Expiration: ⤷ Sign Up

Portugal

Patent: 07905
Estimated Expiration: ⤷ Sign Up

Serbia

Patent: 592
Patent: ČVRSTI PREPARAT KOJI SADRŽI ALOGLIPTIN I PIOGLITAZON (SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE)
Estimated Expiration: ⤷ Sign Up

Slovenia

Patent: 07905
Estimated Expiration: ⤷ Sign Up

South Africa

Patent: 0905621
Patent: Solid preparation comprising alogliptin and pioglitazone
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 1486091
Estimated Expiration: ⤷ Sign Up

Patent: 090109115
Patent: SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 54397
Estimated Expiration: ⤷ Sign Up

Taiwan

Patent: 53041
Estimated Expiration: ⤷ Sign Up

Patent: 0836775
Patent: Solid preparation
Estimated Expiration: ⤷ Sign Up

Patent: 1350143
Patent: Solid preparation
Estimated Expiration: ⤷ Sign Up

Tunisia

Patent: 09000317
Patent: SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE
Estimated Expiration: ⤷ Sign Up

Ukraine

Patent: 828
Patent: ТВЕРДАЯ РЕЦЕПТУРА, КОТОРАЯ СОДЕРЖИТ АЛОГЛИПТИН И ПИОГЛИТАЗОН;ТВЕРДА РЕЦЕПТУРА, ЩО МІСТИТЬ АЛОГЛІПТИН І ПІОГЛІТАЗОН (SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE)
Estimated Expiration: ⤷ Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering OSENI around the world.

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Spain	2310704		⤷ Sign Up
Spain	2354397		⤷ Sign Up
Eurasian Patent Organization	200601701	ИНГИБИТОРЫ ДИПЕПТИДИЛПЕПТИДАЗЫ	⤷ Sign Up
Luxembourg	92615		⤷ Sign Up
Japan	2005041885	METHOD FOR REGULATING GLUCOSE METABOLISM, AND REAGENT RELATED THERETO	⤷ Sign Up
Austria	E488227		⤷ Sign Up
China	1582149		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for OSENI

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1084705	PA2014043	Lithuania	⤷ Sign Up	PRODUCT NAME: SAXAGLIPTINUM; REGISTRATION NO/DATE: EU/1/09/545/001-015 20091001
1084705	C01084705/02	Switzerland	⤷ Sign Up	PRODUCT NAME: VILDAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57834 30.04.2008
1084705	C01084705/01	Switzerland	⤷ Sign Up	PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57863 18.04.2007
1084705	CR 2014 00062	Denmark	⤷ Sign Up	PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091005
1084705	SPC/GB14/083	United Kingdom	⤷ Sign Up	PRODUCT NAME: ALOGLIPTIN; REGISTERED: UK EU/1/13/844 20130923
1174135	C01174135/01	Switzerland	⤷ Sign Up	FORMER REPRESENTATIVE: BOHEST AG, CH
1084705	C01084705/05	Switzerland	⤷ Sign Up	PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 62955 21.11.2013
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Indicators of Generic Entry

AI Research Assistant

Questions you can ask:

Summary for OSENI

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OSENI

Pharmacology for OSENI

Patents protecting OSENI

When does loss-of-exclusivity occur for OSENI?

Make Better Decisions: Try a trial or see plans & pricing

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OSENI