alogliptin / pioglitazone Oral Tablet

Brand(s)
Oseni
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:PIOGLITAZONE
FDAOB
ORAL\TABLET\ALOGLIPTIN BENZOATE: PIOGLITAZONE HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\ALOGLIPTIN BENZOATE: PIOGLITAZONE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\ALOGLIPTIN: PIOGLITAZONE

product(s) by strength(s)

alogliptin 12.5 mg / pioglitazone 15 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640121OseniNDATakeda Pharmaceuticals America, Inc.2013-01-25ALOGLIPTIN BENZOATE, PIOGLITAZONE HYDROCHLORIDEORALTABLET, FILM COATEDNDA0224264c619ed9-fe3e-4158-9938-80c6c3493d55

alogliptin 12.5 mg / pioglitazone 30 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640123OseniNDATakeda Pharmaceuticals America, Inc.2013-01-25ALOGLIPTIN BENZOATE, PIOGLITAZONE HYDROCHLORIDEORALTABLET, FILM COATEDNDA0224264c619ed9-fe3e-4158-9938-80c6c3493d55

alogliptin 12.5 mg / pioglitazone 45 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640124OseniNDATakeda Pharmaceuticals America, Inc.2013-01-25ALOGLIPTIN BENZOATE, PIOGLITAZONE HYDROCHLORIDEORALTABLET, FILM COATEDNDA0224264c619ed9-fe3e-4158-9938-80c6c3493d55

alogliptin 25 mg / pioglitazone 15 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640251OseniNDATakeda Pharmaceuticals America, Inc.2013-01-25ALOGLIPTIN BENZOATE, PIOGLITAZONE HYDROCHLORIDEORALTABLET, FILM COATEDNDA0224264c619ed9-fe3e-4158-9938-80c6c3493d55

alogliptin 25 mg / pioglitazone 30 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640253OseniNDATakeda Pharmaceuticals America, Inc.2013-01-25ALOGLIPTIN BENZOATE, PIOGLITAZONE HYDROCHLORIDEORALTABLET, FILM COATEDNDA0224264c619ed9-fe3e-4158-9938-80c6c3493d55

alogliptin 25 mg / pioglitazone 45 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640254OseniNDATakeda Pharmaceuticals America, Inc.2013-01-25ALOGLIPTIN BENZOATE, PIOGLITAZONE HYDROCHLORIDEORALTABLET, FILM COATEDNDA0224264c619ed9-fe3e-4158-9938-80c6c3493d55

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022426OSENITAKEDA 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, SUBSTANCE
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
p6271243, 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 PREPARATION
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
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
p8637079, SUBSTANCE
p6329404, METHODS OF TREATING DIABETES COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH AN INSULIN SECRETION ENHANCER, SUBSTANCE
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]
NDA022426_001, NDA022426_002, NDA022426_003, NDA022426_004, NDA022426_005, NDA022426_006

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022426_001RXPIOGLITAZONE HYDROCHLORIDE (EQ 15MG BASE), ALOGLIPTIN BENZOATE (EQ 25MG BASE)ORALTABLETFalse2013-01-25OSENI
2NDA022426_002RXPIOGLITAZONE HYDROCHLORIDE (EQ 30MG BASE), ALOGLIPTIN BENZOATE (EQ 25MG BASE)ORALTABLETFalse2013-01-25OSENI
3NDA022426_003RXALOGLIPTIN BENZOATE (EQ 25MG BASE), PIOGLITAZONE HYDROCHLORIDE (EQ 45MG BASE)ORALTABLETTrue2013-01-25OSENI
4NDA022426_004RXALOGLIPTIN BENZOATE (EQ 12.5MG BASE), PIOGLITAZONE HYDROCHLORIDE (EQ 15MG BASE)ORALTABLETFalse2013-01-25OSENI
5NDA022426_005RXPIOGLITAZONE HYDROCHLORIDE (EQ 30MG BASE), ALOGLIPTIN BENZOATE (EQ 12.5MG BASE)ORALTABLETFalse2013-01-25OSENI
6NDA022426_006RXALOGLIPTIN BENZOATE (EQ 12.5MG BASE), PIOGLITAZONE HYDROCHLORIDE (EQ 45MG BASE)ORALTABLETFalse2013-01-25OSENI

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5965584 (view patent)2016-06-19NDA022426, NDA021073, NDA021410, NDA021842, NDA022024, NDA203414Metformin / rosiglitazone Oral Tablet
pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
Metformin / pioglitazone Extended Release Oral Tablet
Metformin / pioglitazone Oral Tablet
2p6150383 (view patent)2016-06-19NDA022426, NDA021073, NDA021925, NDA022271, NDA203414pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
alogliptin Oral Tablet
glimepiride / pioglitazone Oral Tablet
3p6150384 (view patent)2016-06-19NDA022426, NDA021073, NDA203414pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
4p6166042 (view patent)2016-06-19NDA022426, NDA021073, NDA021410, NDA021842, NDA022024, NDA203414Metformin / rosiglitazone Oral Tablet
pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
Metformin / pioglitazone Extended Release Oral Tablet
Metformin / pioglitazone Oral Tablet
5p6166043 (view patent)2016-06-19NDA022426, NDA021073, NDA021842, NDA022024, NDA203414pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
Metformin / pioglitazone Extended Release Oral Tablet
Metformin / pioglitazone Oral Tablet
6p6172090 (view patent)2016-06-19NDA022426, NDA021073, NDA021842, NDA022024, NDA203414pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
Metformin / pioglitazone Extended Release Oral Tablet
Metformin / pioglitazone Oral Tablet
7p6211205 (view patent)2016-06-19NDA022426, NDA021073, NDA021925, NDA022271, NDA203414pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
alogliptin Oral Tablet
glimepiride / pioglitazone Oral Tablet
8p6271243 (view patent)2016-06-19NDA022426, NDA021073pioglitazone Oral Tablet
9p6303640 (view patent)2016-08-09NDA022426, NDA021073, NDA021925, NDA022271, NDA203414pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
alogliptin Oral Tablet
glimepiride / pioglitazone Oral Tablet
10p6303661 (view patent)2017-04-24NDA022426, NDA021995, NDA022044, NDA022271, NDA201280, NDA201281, NDA202270, NDA202343, NDA203414, NDA206073alogliptin / Metformin 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
11p6329404 (view patent)2016-06-19NDA022426, NDA021073, NDA021925, NDA022271, NDA203414pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
alogliptin Oral Tablet
glimepiride / pioglitazone Oral Tablet
12p6890898 (view patent)2019-02-02NDA022426, NDA021995, NDA022044, NDA022271, NDA201280, NDA201281, NDA202270, NDA202343, NDA203414, NDA206073alogliptin / Metformin 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
13p7078381 (view patent)2019-02-02NDA022426, NDA021995, NDA022044, NDA022271, NDA201280, NDA201281, NDA202270, NDA202343, NDA203414, NDA206073alogliptin / Metformin 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
14p7459428 (view patent)2019-02-02NDA022426, NDA022044, NDA022271, NDA201280, NDA201281, NDA202270, NDA202343, NDA203414, NDA206073alogliptin / Metformin 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
15p7807689 (view patent)2028-06-27NDA022426, NDA022271, NDA203414alogliptin / Metformin Oral Tablet
alogliptin Oral Tablet
16p8173663 (view patent)2025-03-15NDA022426, NDA022271, NDA203414alogliptin / Metformin Oral Tablet
alogliptin Oral Tablet
17p8288539 (view patent)2025-03-15NDA022426, NDA022271, NDA203414alogliptin / Metformin Oral Tablet
alogliptin Oral Tablet
18p8637079 (view patent)2029-06-04NDA022426

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
14c619ed9-fe3e-4158-9938-80c6c3493d55 (view SPL)These highlights do not include all the information needed to use OSENI safely and effectively. See full prescribing information for OSENI.OSENI (alogliptin and pioglitazone) tabletsInitial U.S. Approval: 2013prescriptionHuman PrescriptionTakeda Pharmaceuticals America, Inc.2015-08-315647640121, 647640123, 647640124, 647640251, 647640253, 647640254

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