OSENI Drug Patent Profile

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 two patents protecting this drug.

The generic ingredient in OSENI is alogliptin benzoate; pioglitazone hydrochloride. There is one drug master file entry 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

Summary for OSENI

US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	83
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

See drug prices for OSENI

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

Constraining patent/regulatory exclusivity:

8,637,079

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 two US patents.

This potential generic entry date is based on patent 8,637,079.

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

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	7,807,689		Y	Y
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-001	Jan 25, 2013		RX	Yes	No	7,807,689		Y	Y
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-005	Jan 25, 2013		RX	Yes	No	8,637,079		Y

Expired US Patents for OSENI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-003	Jan 25, 2013
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-001	Jan 25, 2013
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-001	Jan 25, 2013

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

Australia

Austria

Brazil

Canada

Chile

China

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Germany

Hong Kong

Israel

Japan

Jordan

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Peru

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

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.

Country	Patent Number	Title	Estimated Expiration
Argentina	005641	COMPOSICION FARMACEUTICA PARA DISMINUIR LA HIPERGLICEMIA Y PARA PROFILAXIS Y TRATAMIENTO DE DIABETES
Argentina	061195	COMPOSICION FARMACEUTICA PARA PROFILAXIS Y TRATAMIENTO DE LA DIABETES
Argentina	065389	COMPOSICION FARMACEUTICA PARA DISMINUIR LA HIPERGLUCEMIA Y PARA PROFILAXIS Y TRATAMIENTO DE LA DIABETES

Supplementary Protection Certificates for OSENI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0861666	91298	Luxembourg		91298, EXPIRES: 20210620
0861666	300258	Netherlands		300258, 20160620, EXPIRES: 20210619
0861666	SPC 038/2006	Ireland		SPC 038/2006: 20070528, EXPIRES: 20210619

DrugChatter Q&A for OSENI

Oseni class action lawsuit?