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Last Updated: October 15, 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 seven patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-six patent family members in twenty-four countries.

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

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

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Recent Clinical Trials for ACTOPLUS MET XR

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

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

See all ACTOPLUS MET XR clinical trials

Recent Litigation for ACTOPLUS MET XR

Identify potential future generic entrants

District Court Litigation
Case NameDate
Shionogi Inc. v. Amneal Pharmaceuticals, LLC2018-10-11
SHIONOGI INC. v. ZYDUS PHARMACEUTICALS (USA) INC.2018-08-16
Shionogi Inc. v. Qingdao Baheal Pharmaceutical Co. Ltd.2017-09-22

See all ACTOPLUS MET XR litigation

PTAB Litigation
PetitionerDate
Aurobindo Pharma USA Inc.2018-01-24
Aurobindo Pharma USA Inc.2017-06-23
Aurobindo Pharma USA Inc.2017-06-22

See all ACTOPLUS MET XR litigation

Synonyms for ACTOPLUS MET XR
737811-27-7
ACTOPLUS MET
Actoplus metformin
LS-188012
Metformin hydrochloride mixture with pioglitazone hydrochloride
Metformin mixture with pioglitazone
Pioglitazone hydrochloride and metformin hydrochloride
Pioglitazone hydrochloride mixture with Metformin hydrochloride
Pioglitazone mixture with metformin

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 DISCN Yes No   See Pricing   See Pricing   See Pricing
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-001 May 12, 2009 DISCN Yes No   See Pricing   See Pricing Y   See Pricing
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-001 May 12, 2009 DISCN Yes No   See Pricing   See Pricing Y   See Pricing
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 DISCN Yes No   See Pricing   See Pricing Y   See Pricing
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 DISCN Yes No   See Pricing   See Pricing   See Pricing
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 DISCN Yes No   See Pricing   See Pricing Y   See Pricing
>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 XR

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   See Pricing

Supplementary Protection Certificates for ACTOPLUS MET XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 CR 2014 00037 Denmark   See Pricing PRODUCT 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
1412357 PA2008013 Lithuania   See Pricing PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
1506211 PA2014026 Lithuania   See Pricing PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
1506211 CA 2014 00037 Denmark   See Pricing PRODUCT 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
1506211 122014000071 Germany   See Pricing 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 1290013-0 Sweden   See Pricing PRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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