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Cantor Fitzgerald
Chinese Patent Office
McKesson
US Army
Healthtrust
US Department of Justice
Dow
Julphar
Queensland Health

Generated: February 16, 2019

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ACTOPLUS MET XR Drug Profile

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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 eleven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and three 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. Ten suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; pioglitazone hydrochloride profile page.

US Patents and Regulatory Information for 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 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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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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 ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-001 May 12, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for ACTOPLUS MET XR
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Tablets 15 mg/1000 mg and 30 mg/1000 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for ACTOPLUS MET XR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014000070 Germany ➤ Try a Free Trial 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
C/GB08/040 United Kingdom ➤ Try a Free Trial PRODUCT NAME: SITAGLIPTIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE MONOPHOSPHATE, PLUS METFORMIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE HYDROCHLORIDE.; REGISTERED: CH 58450 01-03 20080408; UK EU/1/08/455/001 20080716; UK EU/1/08/455/002 20080716; UK EU/1/08/455/003 20080716; UK EU/1/08/455/004 20080716; UK EU/1/08/455/005 20080716; UK EU/1/08/455/006 20080716; UK EU/1/08/455/007 20080716; UK EU/1/08/455/008 20080716; UK EU/1/08/455/009 20080716; UK EU/1/08/455/010 20080716; UK EU/1/08/455/011 20080716; UK EU/1/08/455/012 20080716; UK EU/1/08/455/013 20080716; UK EU/1/08/455/014 20080716
2008 00035 Denmark ➤ Try a Free Trial PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Colorcon
AstraZeneca
Medtronic
Federal Trade Commission
QuintilesIMS
Chubb
Farmers Insurance
Johnson and Johnson

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