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Generated: December 14, 2017

DrugPatentWatch Database Preview

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.

This drug has forty-one patent family members in twenty-five countries and thirty supplementary protection certificates in eleven countries.

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

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms UsaACTOPLUS MET XRmetformin hydrochloride; pioglitazone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Takeda Pharms UsaACTOPLUS METmetformin hydrochloride; pioglitazone hydrochlorideTABLET;ORAL021842-001Aug 29, 2005ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Takeda Pharms UsaACTOPLUS MET XRmetformin hydrochloride; pioglitazone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Takeda Pharms UsaACTOPLUS MET XRmetformin hydrochloride; pioglitazone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Takeda Pharms UsaACTOPLUS MET XRmetformin hydrochloride; pioglitazone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022024-001May 12, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Takeda Pharms UsaACTOPLUS METmetformin hydrochloride; pioglitazone hydrochlorideTABLET;ORAL021842-002Aug 29, 2005ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Takeda Pharms UsaACTOPLUS MET XRmetformin hydrochloride; pioglitazone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022024-001May 12, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Takeda Pharms UsaACTOPLUS MET XRmetformin hydrochloride; pioglitazone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Takeda Pharms UsaACTOPLUS MET XRmetformin hydrochloride; pioglitazone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022024-001May 12, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Takeda Pharms UsaACTOPLUS MET XRmetformin hydrochloride; pioglitazone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: ACTOPLUS MET

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms UsaACTOPLUS METmetformin hydrochloride; pioglitazone hydrochlorideTABLET;ORAL021842-002Aug 29, 2005► Subscribe► Subscribe
Takeda Pharms UsaACTOPLUS METmetformin hydrochloride; pioglitazone hydrochlorideTABLET;ORAL021842-002Aug 29, 2005► Subscribe► Subscribe
Takeda Pharms UsaACTOPLUS METmetformin hydrochloride; pioglitazone hydrochlorideTABLET;ORAL021842-001Aug 29, 2005► Subscribe► Subscribe
Takeda Pharms UsaACTOPLUS METmetformin hydrochloride; pioglitazone hydrochlorideTABLET;ORAL021842-002Aug 29, 2005► Subscribe► Subscribe
Takeda Pharms UsaACTOPLUS METmetformin hydrochloride; pioglitazone hydrochlorideTABLET;ORAL021842-001Aug 29, 2005► Subscribe► Subscribe
Takeda Pharms UsaACTOPLUS METmetformin hydrochloride; pioglitazone hydrochlorideTABLET;ORAL021842-001Aug 29, 2005► Subscribe► Subscribe
Takeda Pharms UsaACTOPLUS METmetformin hydrochloride; pioglitazone hydrochlorideTABLET;ORAL021842-002Aug 29, 2005► Subscribe► Subscribe
Takeda Pharms UsaACTOPLUS METmetformin hydrochloride; pioglitazone hydrochlorideTABLET;ORAL021842-001Aug 29, 2005► Subscribe► Subscribe
Takeda Pharms UsaACTOPLUS METmetformin hydrochloride; pioglitazone hydrochlorideTABLET;ORAL021842-001Aug 29, 2005► Subscribe► Subscribe
Takeda Pharms UsaACTOPLUS METmetformin hydrochloride; pioglitazone hydrochlorideTABLET;ORAL021842-002Aug 29, 2005► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for ACTOPLUS MET

Drugname Dosage Strength RLD Submissiondate
pioglitazone hydrochloride and metformin hydrochlorideExtended-release Tablets15 mg/1000 mg and 30 mg/1000 mgActoplus Met XR9/23/2011
pioglitazone hydrochloride and metformin hydrochlorideTablets15 mg/500 mg and 15 mg/850 mgActoplus Met3/6/2008

International Patent Family for Tradename: ACTOPLUS MET

Country Document Number Estimated Expiration
Hong Kong1080385► Subscribe
South Korea20050070039► Subscribe
South Korea100820609► Subscribe
Russian Federation2357757► Subscribe
Israel167835► Subscribe
Russian Federation2005113999► Subscribe
Morocco27487► Subscribe
Slovenia1561472► Subscribe
JapanWO2006106815► Subscribe
China100427143► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ACTOPLUS MET

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00677Netherlands► SubscribePRODUCT 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
2014000071Germany► SubscribePRODUCT 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
9 5017-2014Slovakia► SubscribePRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
2014026Lithuania► SubscribePRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
C0028France► SubscribePRODUCT 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
2008013,C1412357Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
5006-2008Slovakia► SubscribePRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408
00524Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN SAXAGLIPTINE EN METFORMINE, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN; NAT. REGISTRATION NO/DATE: EU/1/11/731/001-012 20111124; FIRST REGISTRATION:
00569Netherlands► SubscribePRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
/2012Austria► SubscribePRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Cipla
Teva
Novartis
Moodys
Covington
Chinese Patent Office
QuintilesIMS
Deloitte
Daiichi Sankyo

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