ACTOPLUS MET Drug Patent Profile

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

This drug has forty-one patent family members in twenty-five countries.

The generic ingredient in ACTOPLUS MET 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.

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International Patents:	41
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	3
Patent Applications:	36
Drug Prices:	Drug price information for ACTOPLUS MET
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACTOPLUS MET
What excipients (inactive ingredients) are in ACTOPLUS MET?	ACTOPLUS MET excipients list
DailyMed Link:	ACTOPLUS MET at DailyMed

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

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

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

ACTOPLUS MET is protected by two US patents.

Solid preparation
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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	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-001	Aug 29, 2005		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-002	Aug 29, 2005	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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

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

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Country	Patent Number	Title	Estimated Expiration
Luxembourg	91298		⤷ Sign Up
Norway	317341		⤷ Sign Up
Norway	2007007		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	122014000071	Germany	⤷ Sign Up	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
2498758	LUC00152	Luxembourg	⤷ Sign Up	PRODUCT NAME: METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113
1174135	C01174135/01	Switzerland	⤷ Sign Up	FORMER REPRESENTATIVE: BOHEST AG, CH
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description