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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 eleven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and three patent family members in twenty-five countries.

The generic ingredient in ACTOPLUS MET XR is metformin hydrochloride; pioglitazone hydrochloride. There are forty-eight drug master file entries for this compound. Twelve 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:	103
US Patents:	11
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Clinical Trials:	3
Formulation / Manufacturing:	see details
Drug Prices:	see details
DailyMed Link:	ACTOPLUS MET XR at DailyMed

Pharmacology for ACTOPLUS MET XR

Ingredient-type	PPAR alpha PPAR gamma Thiazolidinediones Biguanides
Drug Class	Peroxisome Proliferator Receptor alpha Agonist Peroxisome Proliferator Receptor gamma Agonist Thiazolidinedione Biguanide
Mechanism of Action	Peroxisome Proliferator-activated Receptor Activity

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

Paragraph IV (Patent) Challenges for ACTOPLUS MET XR

Drugname	Dosage	Strength	RLD	Submissiondate
	Extended-release Tablets	15 mg/1000 mg and 30 mg/1000 mg		2011-09-23

Non-Orange Book US Patents for ACTOPLUS MET XR

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,084,058	Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
8,309,125	Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative

International Patents for ACTOPLUS MET XR

Country	Document Number	Estimated Expiration
New Zealand	545653
European Patent Office	1063971
Argentina	054238
Japan	5881962

Supplementary Protection Certificates for ACTOPLUS MET XR

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
77; 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
2014026,C1506211	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
C0006	France		PRODUCT NAME: PIOGLITAZONE/METFORMINE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/06/354/001 DU 20060728; REGISTRATION NO/DATE AT EEC: EU/1/06/354/001 DU 20060728
C0028	France		PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124