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Last Updated: April 24, 2024

ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE - Generic Drug Details

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What are the generic 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
Takeda	Phase 4
Celltrion Pharm, Inc.	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

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	203414-001	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	203414-002	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			⤷ 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	203414-001	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	203414-002	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				⤷ 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	203414-001	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
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	203414-001	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
>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
Peru	20140923	PREPARACION SOLIDA QUE COMPRENDE ALOGLIPTINA Y CLORHIDRATO DE METFORMINA	⤷ Try a Trial
South Korea	20070008620	DIPEPTIDYL PEPTIDASE INHIBITORS	⤷ Try a Trial
European Patent Office	1586571	Inhibiteurs de dipeptidyl peptidase (Dipeptidyl peptidase inhibitors)	⤷ Try a Trial
Colombia	6160301	PREPARACION SOLIDA QUE CONTIENE ALOGLIPTINA Y CLORHIDRATO DE METFORMINA	⤷ Try a Trial
Germany	602004015067		⤷ Try a Trial
Brazil	PI0418639	inibidores de dipeptidil peptidase	⤷ Try a Trial
Israel	220480	נגזרות 1-בנזיל-פירימידין-2,4-דיאון כמעכבי דיפפטידיל פפטידאז, שיטה להכנתן, תכשירים רוקחיים המכילים אותן , ושימוש בהן להכנת תרופות (1-benzyl-pyrimidine-2,4-dione derivatives as dipeptidyl peptidase inhibitors, preparation method thereof, pharmaceutical compositions comprising them and use thereof in the preparation of medicaments)	⤷ 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
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	2014/012	Ireland	⤷ Try a Trial	PRODUCT NAME: ALOGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
1586571	1490014-6	Sweden	⤷ Try a Trial	PERIOD OF VALIDITY (FROM - UNTIL): 20241222 - 20280922
1084705	SPC/GB14/083	United Kingdom	⤷ Try a Trial	PRODUCT NAME: ALOGLIPTIN; REGISTERED: UK EU/1/13/844 20130923
1586571	2014C/010	Belgium	⤷ Try a Trial	PRODUCT NAME: ALOGLIPTINE (EN TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/13/844/001 20130923
1586571	CA 2014 00011	Denmark	⤷ Try a Trial	PRODUCT NAME: ALOGLIPTIN; REG. NO/DATE: EU/1/13/844/001-027 20130919
1586571	CR 2014 00011	Denmark	⤷ Try a Trial	PRODUCT NAME: ALOGLIPTIN; REG. NO/DATE: EU/1/13/844/001-027 20130923
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.