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Generated: December 10, 2018

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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-eight drug master file entries for this compound. Eleven 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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 RX Yes Yes ➤ 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 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-001 May 12, 2009 RX Yes No ➤ 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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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 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 ➤ Sign Up ➤ Sign Up
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 ➤ Sign Up

Supplementary Protection Certificates for ACTOPLUS MET XR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014000070 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
C0028 France ➤ Sign Up 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
77; 5006-2008 Slovakia ➤ Sign Up PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1506211/02 Switzerland ➤ Sign Up PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Cantor Fitzgerald
Colorcon
Deloitte
Merck
Cerilliant
US Army
Healthtrust
Teva

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