Metformin / pioglitazone Extended Release Oral Tablet

Brand(s)
Actoplus Met
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Takeda Pharmaceuticals America, Inc. (2013-11-22)
Oldest Current Product
2010-06-11
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL TABLET\METFORMIN:PIOGLITAZONE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\METFORMIN HYDROCHLORIDE: PIOGLITAZONE HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\METFORMIN HYDROCHLORIDE: PIOGLITAZONE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\METFORMIN: PIOGLITAZONE

product(s) by strength(s)

24 hr metformin hydrochloride 1000 mg / pioglitazone 15 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640510Actoplus MetNDATakeda Pharmaceuticals America, Inc.2010-06-11METFORMIN HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASENDA022024f986164c-51a7-41c2-8952-511b8f46d593

24 hr metformin hydrochloride 1000 mg / pioglitazone 30 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640310Actoplus MetNDATakeda Pharmaceuticals America, Inc.2010-06-11METFORMIN HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASENDA022024f986164c-51a7-41c2-8952-511b8f46d593

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA022024ACTOPLUS MET XRTAKEDA PHARMACEUTICALS USA INC2009-05-12p8475841, ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHO ARE ALREADY TREATED WITH PIOGLITAZONE AND METFORMIN OR WHO HAVE INADEQUATE GLYCEMIC CONTROL ON PIOGLITAZONE OR METFORMIN ALONE
p6866866, SUBSTANCE
p7919116, ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHO ARE ALREADY TREATED WITH PIOGLITAZONE AND METFORMIN OR WHO HAVE INADEQUATE GLYCEMIC CONTROL ON PIOGLITAZONE OR METFORMIN ALONE/ TO REDUCE GASTROINTESTINAL SIDE EFFECTS ADMINISTER WITH A MEAL; AS STARTING DOSE ADMINISTER ONCE DAILY WITH EVENING MEAL
p5965584, ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHO ARE ALREADY TREATED WITH PIOGLITAZONE AND METFORMIN OR WHO HAVE INADEQUATE GLYCEMIC CONTROL ON PIOGLITAZONE OR METFORMIN ALONE, SUBSTANCE
p7785627, SUBSTANCE
p6172090, ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHO ARE ALREADY TREATED WITH PIOGLITAZONE AND METFORMIN OR WHO HAVE INADEQUATE GLYCEMIC CONTROL ON PIOGLITAZONE OR METFORMIN ALONE
p6790459, ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES WHO ARE ALREADY TREATED WITH A PIOGLITAZONE AND METFORMIN
p6166043, ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHO ARE ALREADY TREATED WITH PIOGLITAZONE AND METFORMIN OR WHO HAVE INADEQUATE GLYCEMIC CONTROL ON PIOGLITAZONE OR METFORMIN ALONE
p6099859, SUBSTANCE
p7959946, SUBSTANCE
p6495162, SUBSTANCE
p6166042, ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHO ARE ALREADY TREATED WITH PIOGLITAZONE AND METFORMIN OR WHO HAVE INADEQUATE GLYCEMIC CONTROL ON PIOGLITAZONE OR METFORMIN ALONE
p8668931, SUBSTANCE
p8470368, SUBSTANCE
p9060941, SUBSTANCE
NDA022024_001, NDA022024_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022024_001RXMETFORMIN HYDROCHLORIDE (1GM), PIOGLITAZONE HYDROCHLORIDE (EQ 15MG BASE)ORALTABLET, EXTENDED RELEASEFalse2009-05-12ACTOPLUS MET XR
2NDA022024_002RXPIOGLITAZONE HYDROCHLORIDE (EQ 30MG BASE), METFORMIN HYDROCHLORIDE (1GM)ORALTABLET, EXTENDED RELEASETrue2009-05-12ACTOPLUS MET XR

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5965584 (view patent)2016-06-19NDA022024, NDA021073, NDA021410, NDA021842, NDA022426, NDA203414Metformin / rosiglitazone Oral Tablet
pioglitazone Oral Tablet
alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
Metformin / pioglitazone Oral Tablet
2p6099859 (view patent)2018-03-20NDA022024, NDA021574Metformin Extended Release Oral Tablet
3p6166042 (view patent)2016-06-19NDA022024, NDA021073, NDA021410, NDA021842, NDA022426, NDA203414Metformin / rosiglitazone Oral Tablet
pioglitazone Oral Tablet
alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
Metformin / pioglitazone Oral Tablet
4p6166043 (view patent)2016-06-19NDA022024, NDA021073, NDA021842, NDA022426, NDA203414pioglitazone Oral Tablet
alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
Metformin / pioglitazone Oral Tablet
5p6172090 (view patent)2016-06-19NDA022024, NDA021073, NDA021842, NDA022426, NDA203414pioglitazone Oral Tablet
alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
Metformin / pioglitazone Oral Tablet
6p6495162 (view patent)2018-03-20NDA022024, NDA021574Metformin Extended Release Oral Tablet
7p6790459 (view patent)2021-03-17NDA022024, NDA021574Metformin Extended Release Oral Tablet
8p6866866 (view patent)2021-03-17NDA022024, NDA021574Metformin Extended Release Oral Tablet
9p7785627 (view patent)2026-07-31NDA022024
10p7919116 (view patent)2018-03-20NDA022024, NDA021574Metformin Extended Release Oral Tablet
11p7959946 (view patent)2026-07-31NDA022024
12p8470368 (view patent)2023-09-19NDA022024
13p8475841 (view patent)2018-03-20NDA022024, NDA021574Metformin Extended Release Oral Tablet
14p8668931 (view patent)2023-09-19NDA022024
15p9060941 (view patent)2023-09-19NDA022024

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1f986164c-51a7-41c2-8952-511b8f46d593 (view SPL)These highlights do not include all the information needed to use ACTOPLUS MET XR safely and effectively. See full prescribing information for ACTOPLUS MET XR.ACTOPLUS MET XR (pioglitazone and metformin hydrochloride extended-release) tablets for oral useInitial U.S. Approval: 2009prescriptionHuman PrescriptionTakeda Pharmaceuticals America, Inc.2013-11-226647640310, 647640510

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII