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OSENI Drug Profile

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Which patents cover Oseni, and when can generic versions of Oseni launch?

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

This drug has one hundred and ninety patent family members in forty-three countries.

The generic ingredient in OSENI is alogliptin benzoate; pioglitazone hydrochloride. There are nine 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.

Summary for OSENI

International Patents:	190
US Patents:	8
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
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
DailyMed Link:	OSENI at DailyMed

Generic Entry Opportunity Date for OSENI

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

Ingredient-type	PPAR alpha PPAR gamma Thiazolidinediones
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 Activity

US Patents and Regulatory Information for OSENI

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	022426-002	Jan 25, 2013		RX	Yes	No
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-001	Jan 25, 2013		RX	Yes	No
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-002	Jan 25, 2013		RX	Yes	No
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-002	Jan 25, 2013		RX	Yes	No			Y
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-003	Jan 25, 2013		RX	Yes	Yes

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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	022426-001	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	022426-004	Jan 25, 2013
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-002	Jan 25, 2013
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-004	Jan 25, 2013

Non-Orange Book US Patents for OSENI

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,239,153	Pharmaceutical composition
6,156,773	Pharmaceutical composition
6,169,100	Pharmaceutical composition
6,133,295	Pharmaceutical composition
7,906,523	Dipeptidyl peptidase inhibitors

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International Patents for OSENI

Country	Document Number	Estimated Expiration
Japan	4809806
Serbia	50621
Hong Kong	1041203
Slovenia	1586571
Luxembourg	92374

Supplementary Protection Certificates for OSENI

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB10/011	United Kingdom		PRODUCT NAME: THE COMBINATION OF PIOGLITAZONE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY THE HYDROCHLORIDE SALT, AND GLIMEPIRIDE.; REGISTERED: UK EU/1/06/366/001 20070108; UK EU/1/06/366/002 20070108; UK EU/1/06/366/003 20070108; UK EU/1/06/366/004 20070108; UK EU/1/06/366/005 20070108; UK EU/1/06/366/006 20070108; UK EU/1/06/366/019 20070108; UK EU/1/06/366/020 20070108; UK EU/1/06/366/021 20070108; UK EU/1/06/366/022 20070108; UK EU/1/06/366/013 20070108; UK EU/1/06/366/014 20070108; UK EU/1/06/366/015 20070108; UK EU/1/06/366/016 20070108; UK EU/1/06/366/017 20070108; UK EU/1/06/366/018 20070108; UK EU/1/06/366/007 20070108; UK EU/1/06/366/008 20070108; UK EU
90014-6	Sweden		PRODUCT NAME: ALOGLIPTIN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/13/844 20130919
2014011,C1586571	Lithuania		PRODUCT NAME: ALOGLIPTINAS; REGISTRATION NO/DATE: EU/1/13/844 20130919
2007 00001	Denmark
2014045	Lithuania		PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919