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ACTOPLUS MET XR Drug Profile

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Which patents cover Actoplus Met Xr, and when can generic versions of Actoplus Met Xr launch?

Actoplus Met Xr 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 eighty-six patent family members in twenty-four countries.

The generic ingredient in ACTOPLUS MET XR is metformin hydrochloride; pioglitazone hydrochloride. There are forty-nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; pioglitazone hydrochloride profile page.

Summary for ACTOPLUS MET XR

International Patents:	86
US Patents:	7
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Clinical Trials:	3
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ACTOPLUS MET XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACTOPLUS MET XR
Prior Art and Litigation Support	Order Prior Art and Litigation support for ACTOPLUS MET XR
DailyMed Link:	ACTOPLUS MET XR at DailyMed

Pharmacology for ACTOPLUS MET XR

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

Synonyms for ACTOPLUS MET XR

737811-27-7

ACTOPLUS MET

Actoplus metformin

LS-188012

Metformin hydrochloride mixture with pioglitazone hydrochloride

Metformin mixture with pioglitazone

Pioglitazone hydrochloride and metformin hydrochloride

Pioglitazone hydrochloride mixture with Metformin hydrochloride

Pioglitazone mixture with metformin

US Patents and Regulatory Information for ACTOPLUS MET XR

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	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-001	May 12, 2009		RX	Yes	No
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-001	May 12, 2009		RX	Yes	No			Y
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-001	May 12, 2009		RX	Yes	No			Y
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009		RX	Yes	Yes			Y
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009		RX	Yes	Yes
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009		RX	Yes	Yes			Y

Expired US Patents for ACTOPLUS MET XR

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
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-001	May 12, 2009
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-001	May 12, 2009
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-001	May 12, 2009
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009

Paragraph IV (Patent) Challenges for ACTOPLUS MET XR

Drugname	Dosage	Strength	RLD	Date
	Extended-release Tablets	15 mg/1000 mg and 30 mg/1000 mg

International Patents for ACTOPLUS MET XR

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	0236100
Japan	2007505903
Japan	2004531463
South Korea	20110126761
Argentina	054238
Singapore	160415

Supplementary Protection Certificates for ACTOPLUS MET XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1261586	1290013-0	Sweden		PRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124
1506211	122014000071	Germany		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
1506211	C300677	Netherlands		PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
1412357	77 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408
1261586	2012C/016	Belgium		PRODUCT NAME: UNE COMBINAISON DE PRODUITS DE SAXAGLIPTINE ET DE METFORMINE AINSI QUE TOUT SELS PHARMACEUTIQUEMENT ACCEPTABLES, DONT LES SELS DE CHLORHYDRATE DE SAXAGLIPTINE ET DE METFORMINE; AUTHORISATION NUMBER AND DATE: EU/1/11/731/001 20111128
1412357	PA2008013,C1412357	Lithuania		PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716