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Last Updated: May 16, 2021

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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 nine 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.

DrugPatentWatch® Generic Entry Outlook for Actoplus Met

There have been three 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

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Drug patent expirations by year for ACTOPLUS MET
Drug Prices for ACTOPLUS MET

See drug prices for ACTOPLUS MET

Recent Clinical Trials for ACTOPLUS MET

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

SponsorPhase
National Cancer Institute (NCI)Phase 2
Torrent Pharmaceuticals LimitedPhase 1

See all ACTOPLUS MET clinical trials

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 metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 021842-001 Aug 29, 2005 AB RX Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 DISCN Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-001 May 12, 2009 DISCN Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Takeda Pharms Usa ACTOPLUS MET metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 021842-002 Aug 29, 2005 AB RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 DISCN Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-001 May 12, 2009 DISCN Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 DISCN Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ACTOPLUS MET

Supplementary Protection Certificates for ACTOPLUS MET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1174135 C01174135/01 Switzerland   Get Started for $10 FORMER REPRESENTATIVE: BOHEST AG, CH
1506211 42/2014 Austria   Get Started for $10 PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON UND METFORMIN UND EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/13/900 (MITTEILUNG) 20140121
1174135 SPC/GB10/011 United Kingdom   Get Started for $10 PRODUCT NAME: THE COMBINATION OF PIOGLITAZONE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY THE HYDROCHLORIDE SALT, AND GLIMEPIRIDE.; REGISTERED: UK EU/1/06/366/001 20070108; UK EU/1/06/366/002 20070108; UK EU/1/06/366/003 20070108; UK EU/1/06/366/004 20070108; UK EU/1/06/366/005 20070108; UK EU/1/06/366/006 20070108; UK EU/1/06/366/019 20070108; UK EU/1/06/366/020 20070108; UK EU/1/06/366/021 20070108; UK EU/1/06/366/022 20070108; UK EU/1/06/366/013 20070108; UK EU/1/06/366/014 20070108; UK EU/1/06/366/015 20070108; UK EU/1/06/366/016 20070108; UK EU/1/06/366/017 20070108; UK EU/1/06/366/018 20070108; UK EU/1/06/366/007 20070108; UK EU/1/06/366/008 20070108; UK EU
1506211 C300677 Netherlands   Get Started for $10 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
1261586 2012C/016 Belgium   Get Started for $10 PRODUCT NAME: UNE COMBINAISON DE PRODUITS DE SAXAGLIPTINE ET DE METFORMINE AINSI QUE TOUT SELS PHARMACEUTIQUEMENT ACCEPTABLES, DONT LES SELS DE CHLORHYDRATE DE SAXAGLIPTINE ET DE METFORMINE; AUTHORISATION NUMBER AND DATE: EU/1/11/731/001 20111128
1506211 122014000071 Germany   Get Started for $10 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
1261586 12C0028 France   Get Started for $10 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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