ACTOPLUS MET XR Drug Patent Profile

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 two patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-two patent family members in twenty-five countries.

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

DrugPatentWatch^® Generic Entry Outlook for Actoplus Met Xr

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ACTOPLUS MET XR

International Patents:	72
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	3
Patent Applications:	36
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

See drug prices for ACTOPLUS MET XR

Recent Clinical Trials for ACTOPLUS MET XR

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
Torrent Pharmaceuticals Limited	Phase 1

See all ACTOPLUS MET XR clinical trials

Paragraph IV (Patent) Challenges for ACTOPLUS MET XR

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 ACTOPLUS MET XR

ACTOPLUS MET XR is protected by two US patents.

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

International Patents for ACTOPLUS MET XR

See the table below for patents covering ACTOPLUS MET XR around the world.

Country	Patent Number	Title	Estimated Expiration
China	1308520
Canada	2427195	COMPOSITIONS DE METFORMINE A LIBERATION CONTROLEE (CONTROLLED RELEASE METFORMIN COMPOSITIONS)
China	100544717
Canada	2324493	COMPRIMES ORAUX A NOYAU MONOLITHIQUE A LIBERATION CONTROLEE (CONTROLLED RELEASE ORAL TABLET HAVING A UNITARY CORE)

Supplementary Protection Certificates for ACTOPLUS MET XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1174135	91606	Luxembourg		91606, EXPIRES: 20210620
1730131	C01730131/02	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
1506211	C 2014 029	Romania		PRODUCT NAME: COMBINATIE DE DAPAGLIFLOZIN SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA SI METFORMINA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/900; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/900; DATE OF FIRST AUTHORISATION IN EEA: 20140116
1506211	300677	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