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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 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.

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

Drug Class	Dipeptidyl Peptidase 4 Inhibitor Thiazolidinedione Peroxisome Proliferator Receptor alpha Agonist Peroxisome Proliferator Receptor gamma Agonist
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			Y
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-001	Jan 25, 2013		RX	Yes	No			Y
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
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-003	Jan 25, 2013		RX	Yes	Yes				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	022426-001	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	022426-003	Jan 25, 2013
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-006	Jan 25, 2013
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-005	Jan 25, 2013

International Patents for OSENI

Country	Document Number	Estimated Expiration
Spain	2288807
Germany	122009000064
Germany	602004015067
Malaysia	146290
Tunisia	2009000317

Supplementary Protection Certificates for OSENI

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
14/012	Ireland		PRODUCT NAME: ALOGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
0861666/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
C/GB07/009	United Kingdom		SPC/GB07/009: 20070126
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
2007 00001	Denmark