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KAZANO Drug Profile

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When do Kazano patents expire, and what generic alternatives are available?

Kazano is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and six patent family members in thirty-eight countries.

The generic ingredient in KAZANO is alogliptin benzoate; metformin 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; metformin hydrochloride profile page.

Summary for KAZANO

International Patents:	106
US Patents:	7
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	1
Clinical Trials:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for KAZANO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KAZANO
DailyMed Link:	KAZANO at DailyMed

Generic Entry Opportunity Date for KAZANO

NDA:

203414

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 KAZANO

Drug Class	Dipeptidyl Peptidase 4 Inhibitor Biguanide
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

Synonyms for KAZANO

Alogliptin / metformin

Alogliptin / metformin hydrochloride

Alogliptin and metformin hydrochloride

Alogliptin mixture with metformin

Alogliptin mixture with metformin hydrochloride

S900006100

SYR-322 + metformin hydrochloride

US Patents and Regulatory Information for KAZANO

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	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013		RX	Yes	Yes			Y
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013		RX	Yes	No
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013		RX	Yes	Yes
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013		RX	Yes	Yes			Y	Y
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013		RX	Yes	No

Expired US Patents for KAZANO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013

Paragraph IV (Patent) Challenges for KAZANO

Drugname	Dosage	Strength	RLD	Date
	Tablets	12.5 mg/500 mg and 12.5 mg/1000 mg

International Patents for KAZANO

Country	Patent Number	Estimated Expiration
Japan	3895349
Canada	2694620
Costa Rica	11267
Taiwan	I344962
Germany	602004015067

Supplementary Protection Certificates for KAZANO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586571	1490014-6	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 2024-12-22 TILL - 2028-09-22
1586571	CA 2014 00011	Denmark		PRODUCT NAME: ALOGLIPTIN; REG. NO/DATE: EU/1/13/844/001-027 20130919
1084705	PA2014045	Lithuania		PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
1586571	CR 2014 00011	Denmark		PRODUCT NAME: ALOGLIPTIN; REG. NO/DATE: EU/1/13/844/001-027 20130923
1586571	300640	Netherlands		PRODUCT NAME: ALOGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/844/001-007 20130923