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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Accenture
Merck
Baxter
Chubb
AstraZeneca
Fish and Richardson
Mallinckrodt
Moodys
Harvard Business School

Generated: August 22, 2017

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ACTOPLUS MET Drug Profile

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What is the patent landscape for Actoplus Met, and what generic Actoplus Met 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 thirty-six patent family members in twenty-five 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.

Summary for Tradename: ACTOPLUS MET

Patents:2
Applicants:1
NDAs:2
Suppliers / Packagers: see list4
Clinical Trials: see list1,292
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ACTOPLUS MET at DailyMed
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;ORAL022024-002May 12, 2009RXYesYes► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
ACTOPLUS MET
metformin hydrochloride; pioglitazone hydrochloride
TABLET;ORAL021842-001Aug 29, 2005ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYesYes► Subscribe► SubscribeY ► Subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYesYes► Subscribe► SubscribeY ► Subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-001May 12, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: ACTOPLUS MET

Paragraph IV activity 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
Portugal1561472► Subscribe
Japan2008208141► Subscribe
Costa Rica7797► Subscribe
MexicoPA05003668► Subscribe
Australia2003271103► 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
2008013Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
2014 00037Denmark► SubscribePRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
2014 00037Denmark► SubscribePRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
2012022Lithuania► SubscribePRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
128Luxembourg► SubscribePRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
US Army
Covington
Colorcon
Citi
Novartis
Julphar
Daiichi Sankyo
Mallinckrodt
Fuji

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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