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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.

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

Summary for ACTOPLUS MET XR

US Patents:	11
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
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	022024-002	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

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	Document Number	Estimated Expiration
Spain	2540972
China	101623274
Canada	2499597
Canada	2537665

Supplementary Protection Certificates for ACTOPLUS MET XR

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2014000070	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
2013 00001	Denmark		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720
00357	Netherlands		PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
2012022	Lithuania		PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720