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Last Updated: April 19, 2024

Alogliptin benzoate; metformin hydrochloride - Generic Drug Details

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What are the generic drug sources for alogliptin benzoate; metformin hydrochloride and what is the scope of freedom to operate?

Alogliptin benzoate; metformin hydrochloride is the generic ingredient in one branded drug marketed by Takeda Pharms Usa and is included in one NDA. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Alogliptin benzoate; metformin hydrochloride has ninety patent family members in forty-one countries.

Three suppliers are listed for this compound.

Summary for alogliptin benzoate; metformin hydrochloride

International Patents:	90
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Clinical Trials:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for alogliptin benzoate; metformin hydrochloride
DailyMed Link:	alogliptin benzoate; metformin hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for alogliptin benzoate; metformin hydrochloride

Generic Entry Date for alogliptin benzoate; metformin hydrochloride^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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.

Recent Clinical Trials for alogliptin benzoate; metformin hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Celltrion Pharm, Inc.	Phase 4
Takeda	Phase 4
Seoul National University Hospital	Phase 4

See all alogliptin benzoate; metformin hydrochloride clinical trials

Pharmacology for alogliptin benzoate; metformin hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for alogliptin benzoate; metformin hydrochloride

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

A10BH	Dipeptidyl peptidase 4 (DPP-4) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KAZANO	Tablets	alogliptin benzoate; metformin hydrochloride	12.5 mg/500 mg and 12.5 mg/1000 mg	203414	3	2017-01-25

US Patents and Regulatory Information for alogliptin benzoate; metformin hydrochloride

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Glossary

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

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

International Patents for alogliptin benzoate; metformin hydrochloride

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Country	Patent Number	Title	Estimated Expiration
Norway	20064669		⤷ Try a Trial
Georgia, Republic of	P20125672	) SOLID COMPOSITION CONTAINING ALOGLIPTIN AND METFORMIN HYDROCHLORIDE	⤷ Try a Trial
Japan	2010533643		⤷ Try a Trial
Malaysia	159203	SOLID PREPARATION COMPRISING ALOGLIPTIN AND METFORMIN HYDROCHLORIDE	⤷ Try a Trial
Croatia	P20080509		⤷ Try a Trial
Spain	2603879		⤷ Try a Trial
European Patent Office	2185138	PREPARATION SOLIDE COMPRENANT DU ALOGLIPTIN ET METFORMIN CHLORHYDRATE (SOLID PREPARATION COMPRISING ALOGLIPTIN AND METFORMIN HYDROCHLORIDE)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for alogliptin benzoate; metformin hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1084705	C01084705/05	Switzerland	⤷ Try a Trial	PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 62955 21.11.2013
1586571	16/2014	Austria	⤷ Try a Trial	PRODUCT NAME: ALOGLIPTIN UND SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/13/844 (MITTEILUNG) 20130923
1586571	300640	Netherlands	⤷ Try a Trial	PRODUCT NAME: ALOGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/844/001-007 20130923
1586571	C 2014 011	Romania	⤷ Try a Trial	PRODUCT NAME: ALOGLIPTIN; NATIONAL AUTHORISATION NUMBER: EU/1/13/844/001 - EU/1/13/844/027; DATE OF NATIONAL AUTHORISATION: 20130919; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/844/001 - EU/1/13/844/027; DATE OF FIRST AUTHORISATION IN EEA: 20130919
1586571	132014902238640	Italy	⤷ Try a Trial	PRODUCT NAME: ALOGLIPTIN IN TUTTE LE FORME PROTETTE DAL BREVETTO DI BASE(VIPIDIA); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/13/844/001 A EU/1/13/844/027, 20130923
1586571	172 5006-2014	Slovakia	⤷ Try a Trial	PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001 - EU/1/13/844/027 20130919
1586571	92374	Luxembourg	⤷ Try a Trial	PRODUCT NAME: ALOGLIPTIN SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE. FIRST REGISTRATION: 20130923
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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