Metformin hydrochloride; pioglitazone hydrochloride - Generic Drug Details

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

Metformin hydrochloride; pioglitazone hydrochloride is the generic ingredient in three branded drugs marketed by Takeda Pharms Usa, Aurobindo Pharma Ltd, Chartwell Rx, Macleods Pharms Ltd, Norvium Bioscience, Teva Pharms Usa, and Torrent Pharms Ltd, and is included in eight NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Metformin hydrochloride; pioglitazone hydrochloride has one hundred and thirteen patent family members in thirty-two countries.

Five suppliers are listed for this compound.

Summary for metformin hydrochloride; pioglitazone hydrochloride

International Patents:	113
US Patents:	4
Tradenames:	3
Applicants:	7
NDAs:	8
Finished Product Suppliers / Packagers:	5
Clinical Trials:	155
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for metformin hydrochloride; pioglitazone hydrochloride
DailyMed Link:	metformin hydrochloride; pioglitazone hydrochloride at DailyMed

Recent Clinical Trials for metformin hydrochloride; pioglitazone hydrochloride

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

Sponsor	Phase
University of Minnesota	Phase 2
Nanjing First Hospital, Nanjing Medical University	Phase 3
Affiliated Hospital of Nantong University	Phase 1

See all metformin hydrochloride; pioglitazone hydrochloride clinical trials

Pharmacology for metformin hydrochloride; pioglitazone hydrochloride

Drug Class	Biguanide Peroxisome Proliferator Receptor alpha Agonist Peroxisome Proliferator Receptor gamma Agonist Thiazolidinedione
Mechanism of Action	Peroxisome Proliferator-activated Receptor alpha Agonists Peroxisome Proliferator-activated Receptor gamma Agonists Peroxisome Proliferator-activated Receptor Activity

Anatomical Therapeutic Chemical (ATC) Classes for metformin hydrochloride; pioglitazone hydrochloride

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

A10BG	Thiazolidinediones
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ACTOPLUS MET XR	Extended-release Tablets	metformin hydrochloride; pioglitazone hydrochloride	15 mg/1000 mg and 30 mg/1000 mg	022024	1	2011-09-23

US Patents and Regulatory Information for metformin hydrochloride; 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
Macleods Pharms Ltd	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	204802-002	Nov 5, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Norvium Bioscience	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	090406-002	Feb 25, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	200823-001	Feb 13, 2013	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	091273-001	Apr 16, 2013		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Macleods Pharms Ltd	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	204802-001	Nov 5, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-002	Aug 29, 2005	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-001	May 12, 2009		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 metformin hydrochloride; pioglitazone hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-001	May 12, 2009	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-001	Aug 29, 2005	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-001	Aug 29, 2005	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for metformin hydrochloride; pioglitazone hydrochloride

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Country	Patent Number	Title	Estimated Expiration
China	1717253	Solid preparation	⤷ Sign Up
Israel	167835	SOLID PREPARATION COMPRISING PIOGLITAZONE AND BIGUANIDE AND PROCESS FOR PRODUCING THE SAME	⤷ Sign Up
New Zealand	552559	Solid preparation comprising an insulin sensitizer and an active ingredient (except insulin sensitizers), which is useful as a therapeutic drug for diabetes and the like	⤷ Sign Up
Taiwan	200718433	Novel pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative	⤷ Sign Up
Canada	2537665	NOUVELLE PREPARATION PHARMACEUTIQUE CONTENANT UN BIGUANIDE ET UN DERIVE THIAZOLIDINEDIONE (NOVEL PHARMACEUTICAL FORMULATION CONTAINING A BIGUANIDE AND A THIAZOLIDINEDIONE DERIVATIVE)	⤷ Sign Up
Canada	2601501	NOUVELLE FORMULATION PHARMACEUTIQUE CONTENANT UN BIGUANIDE ET UN DERIVE DE THIAZOLIDINEDIONE (NOVEL PHARMACEUTICAL FORMULATION CONTAINING A BIGUANIDE AND A THIAZOLIDINEDIONE DERIVATIVE)	⤷ Sign Up
New Zealand	539711	Solid preparation	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for metformin hydrochloride; pioglitazone hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	PA2014026	Lithuania	⤷ Sign Up	PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
1506211	CA 2014 00037	Denmark	⤷ Sign Up	PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
1506211	42/2014	Austria	⤷ Sign Up	PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON UND METFORMIN UND EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/13/900 (MITTEILUNG) 20140121
1506211	132014902277722	Italy	⤷ Sign Up	PRODUCT NAME: UNA COMBINAZIONE DI DAPAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE COME PROTETTI DAL BREVETTO DI BASE EP1506211(XIGDUO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/900, 20140116
1261586	15/2012	Austria	⤷ Sign Up	PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
2498758	301040	Netherlands	⤷ Sign Up	PRODUCT NAME: METFORMINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; SAXAGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1401 20191113
2498758	PA2020003,C2498758	Lithuania	⤷ Sign Up	PRODUCT NAME: METFORMINO HIDROCHLORIDAS; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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