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ACTOPLUS MET Drug Profile

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When do Actoplus Met patents expire, and what generic alternatives are available?

Actoplus Met is a drug marketed by Takeda Pharms Usa and is included in two NDAs. There are thirteen patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in ACTOPLUS MET 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

US Patents:	2
Applicants:	1
NDAs:	2
Suppliers / Packagers:	2
Bulk Api Vendors:	1
Clinical Trials:	3
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ACTOPLUS MET
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACTOPLUS MET
DailyMed Link:	ACTOPLUS MET at DailyMed

Pharmacology for ACTOPLUS MET

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

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	022024-002	May 12, 2009		RX	Yes	Yes			Y
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-001	Aug 29, 2005	AB	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

Expired US Patents for ACTOPLUS MET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-002	Aug 29, 2005
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-001	Aug 29, 2005
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-001	Aug 29, 2005

Paragraph IV (Patent) Challenges for ACTOPLUS MET

Drugname	Dosage	Strength	RLD	Date
	Extended-release Tablets	15 mg/1000 mg and 30 mg/1000 mg
	Tablets	15 mg/500 mg and 15 mg/850 mg

International Patents for ACTOPLUS MET

Country	Document Number	Estimated Expiration
Slovenia	1561472
Cyprus	1114863
Poland	219608

Supplementary Protection Certificates for ACTOPLUS MET

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2012022	Lithuania		PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
1506211/02	Switzerland		PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
77; 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716