alogliptin / Metformin Oral Tablet

Brand(s)
Kazano
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Takeda Pharmaceuticals America, Inc. (2015-08-31)
Oldest Current Product
2013-01-25
License(s)
NDA
RxNORM
ORAL TABLET\ALOGLIPTIN:METFORMIN
FDAOB
ORAL\TABLET\ALOGLIPTIN BENZOATE: METFORMIN HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\ALOGLIPTIN BENZOATE: METFORMIN HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\ALOGLIPTIN: METFORMIN

product(s) by strength(s)

alogliptin 12.5 mg / metformin hydrochloride 1000 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640337KazanoNDATakeda Pharmaceuticals America, Inc.2013-01-25ALOGLIPTIN BENZOATE, METFORMIN HYDROCHLORIDEORALTABLET, FILM COATEDNDA20341483cb7914-a683-47bb-a713-f2bc6a596bd2

alogliptin 12.5 mg / metformin hydrochloride 500 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640335KazanoNDATakeda Pharmaceuticals America, Inc.2013-01-25ALOGLIPTIN BENZOATE, METFORMIN HYDROCHLORIDEORALTABLET, FILM COATEDNDA20341483cb7914-a683-47bb-a713-f2bc6a596bd2

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203414KAZANOTAKEDA PHARMACEUTICALS USA INC2013-01-25p6211205, METHODS OF REDUCING THE AMOUNT OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC PATIENT COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH AN INSULIN SECRETION ENHANCER
p5965584, METHODS OF TREATING DIABETES COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH A BIGUANIDE SUCH AS METFORMIN
p6303640, METHODS OF REDUCING THE SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC PATIENT COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH AN INSULIN SECRETION ENHANCER
p6172090, METHODS OF REDUCING THE SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC PATIENT COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH A BIGUANIDE SUCH AS METFORMIN
p6890898, METHODS OF MODIFYING GLUCOSE METABOLISM AND TREATING DIABETES COMPRISING ADMINISTERING A DIPEPTIDYL PEPTIDASE INHIBITOR AND ONE OR MORE OTHER THERAPEUTIC AGENTS SUCH AS METFORMIN
p6303661, METHODS OF LOWERING ELEVATED POST PRANDIAL BLOOD GLUCOSE LEVELS COMPRISING ADMINISTERING A DIPEPTIDYL PEPTIDASE INHIBITOR
p6150384, METHODS OF TREATING LIPID METABOLISM DISORDERS COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH A BIGUANIDE SUCH AS METFORMIN
p6150383, METHODS OF TREATING LIPID METABOLISM AND GLYCOMETABOLISM DISORDERS COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH AN INSULIN SECRETION ENHANCER
p7078381, METHODS OF MODIFYING GLUCOSE METABOLISM AND TREATING DIABETES COMPRISING ADMINISTERING A DIPEPTIDYL PEPTIDASE INHIBITOR AND ONE OR MORE OTHER THERAPEUTIC AGENTS SUCH AS METFORMIN
p7459428, METHODS OF TREATING DIABETES COMPRISING ADMINISTERING A DIPEPTIDYL PEPTIDASE INHIBITOR AND METFORMIN
p8900638, SUBSTANCE
p7807689, METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN, SUBSTANCE
p8173663, METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
p6166042, METHODS OF TREATING GLYCOMETABOLISM DISORDERS COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH A BIGUANIDE SUCH AS METFORMIN
p6329404, METHODS OF TREATING DIABETES COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH AN INSULIN SECRETION ENHANCER
p6166043, METHODS OF REDUCING THE AMOUNT OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC PATIENT COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH A BIGUANIDE SUCH AS METFORMIN
p8288539
NEW COMBINATION [2016-01-25]
NEW CHEMICAL ENTITY [2018-01-25]
NDA203414_001, NDA203414_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203414_001RXMETFORMIN HYDROCHLORIDE (500MG), ALOGLIPTIN BENZOATE (EQ 12.5MG BASE)ORALTABLETFalse2013-01-25KAZANO
2NDA203414_002RXALOGLIPTIN BENZOATE (EQ 12.5MG BASE), METFORMIN HYDROCHLORIDE (1GM)ORALTABLETTrue2013-01-25KAZANO

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5965584 (view patent)2016-06-19NDA203414, NDA021073, NDA021410, NDA021842, NDA022024, NDA022426Metformin / rosiglitazone Oral Tablet
pioglitazone Oral Tablet
alogliptin / pioglitazone Oral Tablet
Metformin / pioglitazone Extended Release Oral Tablet
Metformin / pioglitazone Oral Tablet
2p6150383 (view patent)2016-06-19NDA203414, NDA021073, NDA021925, NDA022271, NDA022426pioglitazone Oral Tablet
alogliptin / pioglitazone Oral Tablet
alogliptin Oral Tablet
glimepiride / pioglitazone Oral Tablet
3p6150384 (view patent)2016-06-19NDA203414, NDA021073, NDA022426pioglitazone Oral Tablet
alogliptin / pioglitazone Oral Tablet
4p6166042 (view patent)2016-06-19NDA203414, NDA021073, NDA021410, NDA021842, NDA022024, NDA022426Metformin / rosiglitazone Oral Tablet
pioglitazone Oral Tablet
alogliptin / pioglitazone Oral Tablet
Metformin / pioglitazone Extended Release Oral Tablet
Metformin / pioglitazone Oral Tablet
5p6166043 (view patent)2016-06-19NDA203414, NDA021073, NDA021842, NDA022024, NDA022426pioglitazone Oral Tablet
alogliptin / pioglitazone Oral Tablet
Metformin / pioglitazone Extended Release Oral Tablet
Metformin / pioglitazone Oral Tablet
6p6172090 (view patent)2016-06-19NDA203414, NDA021073, NDA021842, NDA022024, NDA022426pioglitazone Oral Tablet
alogliptin / pioglitazone Oral Tablet
Metformin / pioglitazone Extended Release Oral Tablet
Metformin / pioglitazone Oral Tablet
7p6211205 (view patent)2016-06-19NDA203414, NDA021073, NDA021925, NDA022271, NDA022426pioglitazone Oral Tablet
alogliptin / pioglitazone Oral Tablet
alogliptin Oral Tablet
glimepiride / pioglitazone Oral Tablet
8p6303640 (view patent)2016-08-09NDA203414, NDA021073, NDA021925, NDA022271, NDA022426pioglitazone Oral Tablet
alogliptin / pioglitazone Oral Tablet
alogliptin Oral Tablet
glimepiride / pioglitazone Oral Tablet
9p6303661 (view patent)2017-04-24NDA203414, NDA021995, NDA022044, NDA022271, NDA022426, NDA201280, NDA201281, NDA202270, NDA202343, NDA206073alogliptin / pioglitazone Oral Tablet
empagliflozin / Linagliptin Oral Tablet
Metformin / sitagliptin Extended Release Oral Tablet
Metformin / sitagliptin Oral Tablet
Linagliptin / Metformin Oral Tablet
sitagliptin Oral Tablet
alogliptin Oral Tablet
Linagliptin Oral Tablet
10p6329404 (view patent)2016-06-19NDA203414, NDA021073, NDA021925, NDA022271, NDA022426pioglitazone Oral Tablet
alogliptin / pioglitazone Oral Tablet
alogliptin Oral Tablet
glimepiride / pioglitazone Oral Tablet
11p6890898 (view patent)2019-02-02NDA203414, NDA021995, NDA022044, NDA022271, NDA022426, NDA201280, NDA201281, NDA202270, NDA202343, NDA206073alogliptin / pioglitazone Oral Tablet
empagliflozin / Linagliptin Oral Tablet
Metformin / sitagliptin Extended Release Oral Tablet
Metformin / sitagliptin Oral Tablet
Linagliptin / Metformin Oral Tablet
sitagliptin Oral Tablet
alogliptin Oral Tablet
Linagliptin Oral Tablet
12p7078381 (view patent)2019-02-02NDA203414, NDA021995, NDA022044, NDA022271, NDA022426, NDA201280, NDA201281, NDA202270, NDA202343, NDA206073alogliptin / pioglitazone Oral Tablet
empagliflozin / Linagliptin Oral Tablet
Metformin / sitagliptin Extended Release Oral Tablet
Metformin / sitagliptin Oral Tablet
Linagliptin / Metformin Oral Tablet
sitagliptin Oral Tablet
alogliptin Oral Tablet
Linagliptin Oral Tablet
13p7459428 (view patent)2019-02-02NDA203414, NDA022044, NDA022271, NDA022426, NDA201280, NDA201281, NDA202270, NDA202343, NDA206073alogliptin / pioglitazone Oral Tablet
empagliflozin / Linagliptin Oral Tablet
Metformin / sitagliptin Extended Release Oral Tablet
Metformin / sitagliptin Oral Tablet
Linagliptin / Metformin Oral Tablet
alogliptin Oral Tablet
Linagliptin Oral Tablet
14p7807689 (view patent)2028-06-27NDA203414, NDA022271, NDA022426alogliptin / pioglitazone Oral Tablet
alogliptin Oral Tablet
15p8173663 (view patent)2025-03-15NDA203414, NDA022271, NDA022426alogliptin / pioglitazone Oral Tablet
alogliptin Oral Tablet
16p8288539 (view patent)2025-03-15NDA203414, NDA022271, NDA022426alogliptin / pioglitazone Oral Tablet
alogliptin Oral Tablet
17p8900638 (view patent)2029-05-24NDA203414

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
183cb7914-a683-47bb-a713-f2bc6a596bd2 (view SPL)These highlights do not include all the information needed to use KAZANO safely and effectively. See full prescribing information for KAZANO. KAZANO (alogliptin and metformin HCl) tablets for oral administrationInitial U.S. Approval: 2013prescriptionHuman PrescriptionTakeda Pharmaceuticals America, Inc.2015-08-315647640335, 647640337

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