Alogliptin benzoate; pioglitazone hydrochloride - Generic Drug Details

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

Alogliptin benzoate; pioglitazone 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. Additional information is available in the individual branded drug profile pages.

Alogliptin benzoate; pioglitazone hydrochloride has one hundred and one patent family members in forty-two countries.

Two suppliers are listed for this compound.

Summary for alogliptin benzoate; pioglitazone hydrochloride

International Patents:	101
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	4
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for alogliptin benzoate; pioglitazone hydrochloride
DailyMed Link:	alogliptin benzoate; pioglitazone hydrochloride at DailyMed

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

Generic Entry Date for alogliptin benzoate; pioglitazone hydrochloride^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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; pioglitazone hydrochloride

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

Sponsor	Phase
Yonsei University	Phase 4
Celltrion Pharm, Inc.	Phase 4
Takeda	Phase 4

See all alogliptin benzoate; pioglitazone hydrochloride clinical trials

Pharmacology for alogliptin benzoate; pioglitazone hydrochloride

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 alpha Agonists Peroxisome Proliferator-activated Receptor gamma Agonists

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

A10BG	Thiazolidinediones
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

US Patents and Regulatory Information for alogliptin benzoate; pioglitazone 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	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-002	Jan 25, 2013		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-005	Jan 25, 2013		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-002	Jan 25, 2013		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-003	Jan 25, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-004	Jan 25, 2013		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
>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; pioglitazone hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-003	Jan 25, 2013	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-006	Jan 25, 2013	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-004	Jan 25, 2013	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-002	Jan 25, 2013	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-005	Jan 25, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for alogliptin benzoate; pioglitazone hydrochloride

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Country	Patent Number	Title	Estimated Expiration
Morocco	28469	INHIBITEURS DE LA DIPEPTIDYLE PEPTIDASE	⤷ Sign Up
Peru	20081663	PREPARACION SOLIDA QUE COMPRENDE ALOGLIPTIN Y PIOGLITAZONA	⤷ Sign Up
Denmark	1586571		⤷ Sign Up
China	102134231	Dipeptidyl peptidase inhibitors	⤷ Sign Up
Serbia	51592	ČVRSTI PREPARAT KOJI SADRŽI ALOGLIPTIN I PIOGLITAZON (SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for alogliptin benzoate; pioglitazone hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586571	C01586571/01	Switzerland	⤷ Sign Up	PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: AUTORISATION SWISSMEDIC 62955 22.11.2013
1586571	122014000019	Germany	⤷ Sign Up	PRODUCT NAME: VIPIDIA - ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
1586571	1490014-6	Sweden	⤷ Sign Up	PERIOD OF VALIDITY (FROM - UNTIL): 20241222 - 20280922
1586571	252 5006-2014	Slovakia	⤷ Sign Up	PRODUCT NAME: ALOGLIPTIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/13/844/001 - EU/1/13/844/027 20130923
1586571	300640	Netherlands	⤷ Sign Up	PRODUCT NAME: ALOGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/844/001-007 20130923
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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