alogliptin Oral Tablet

Brand(s)
Nesina
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
FDAOB
ORAL\TABLET\ALOGLIPTIN BENZOATE
SPL Active
ORAL\TABLET, FILM COATED\ALOGLIPTIN BENZOATE
SPL Moiety
ORAL\TABLET, FILM COATED\ALOGLIPTIN

product(s) by strength(s)

alogliptin 12.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640125NesinaNDATakeda Pharmaceuticals America, Inc.2013-01-25ALOGLIPTIN BENZOATEORALTABLET, FILM COATEDNDA022271a3768c7e-aa4c-44d3-bc53-43bb7346c0b0

alogliptin 25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640250NesinaNDATakeda Pharmaceuticals America, Inc.2013-01-25ALOGLIPTIN BENZOATEORALTABLET, FILM COATEDNDA022271a3768c7e-aa4c-44d3-bc53-43bb7346c0b0

alogliptin 6.25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640625NesinaNDATakeda Pharmaceuticals America, Inc.2013-01-25ALOGLIPTIN BENZOATEORALTABLET, FILM COATEDNDA022271a3768c7e-aa4c-44d3-bc53-43bb7346c0b0

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022271NESINATAKEDA 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
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
p8697125, SUBSTANCE
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
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
p6329404, METHODS OF TREATING DIABETES COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH AN INSULIN SECRETION ENHANCER, SUBSTANCE
p8288539
NEW CHEMICAL ENTITY [2018-01-25]NDA022271_001, NDA022271_002, NDA022271_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022271_001RXALOGLIPTIN BENZOATE (EQ 6.25MG BASE)ORALTABLETFalse2013-01-25NESINA
2NDA022271_002RXALOGLIPTIN BENZOATE (EQ 12.5MG BASE)ORALTABLETFalse2013-01-25NESINA
3NDA022271_003RXALOGLIPTIN BENZOATE (EQ 25MG BASE)ORALTABLETTrue2013-01-25NESINA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6150383 (view patent)2016-06-19NDA022271, NDA021073, NDA021925, NDA022426, NDA203414pioglitazone Oral Tablet
alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
glimepiride / pioglitazone Oral Tablet
2p6211205 (view patent)2016-06-19NDA022271, NDA021073, NDA021925, NDA022426, NDA203414pioglitazone Oral Tablet
alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
glimepiride / pioglitazone Oral Tablet
3p6303640 (view patent)2016-08-09NDA022271, NDA021073, NDA021925, NDA022426, NDA203414pioglitazone Oral Tablet
alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
glimepiride / pioglitazone Oral Tablet
4p6303661 (view patent)2017-04-24NDA022271, NDA021995, NDA022044, NDA022426, NDA201280, NDA201281, NDA202270, NDA202343, NDA203414, NDA206073alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
empagliflozin / Linagliptin Oral Tablet
Metformin / sitagliptin Extended Release Oral Tablet
Metformin / sitagliptin Oral Tablet
Linagliptin / Metformin Oral Tablet
sitagliptin Oral Tablet
Linagliptin Oral Tablet
5p6329404 (view patent)2016-06-19NDA022271, NDA021073, NDA021925, NDA022426, NDA203414pioglitazone Oral Tablet
alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
glimepiride / pioglitazone Oral Tablet
6p6890898 (view patent)2019-02-02NDA022271, NDA021995, NDA022044, NDA022426, NDA201280, NDA201281, NDA202270, NDA202343, NDA203414, NDA206073alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
empagliflozin / Linagliptin Oral Tablet
Metformin / sitagliptin Extended Release Oral Tablet
Metformin / sitagliptin Oral Tablet
Linagliptin / Metformin Oral Tablet
sitagliptin Oral Tablet
Linagliptin Oral Tablet
7p7078381 (view patent)2019-02-02NDA022271, NDA021995, NDA022044, NDA022426, NDA201280, NDA201281, NDA202270, NDA202343, NDA203414, NDA206073alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
empagliflozin / Linagliptin Oral Tablet
Metformin / sitagliptin Extended Release Oral Tablet
Metformin / sitagliptin Oral Tablet
Linagliptin / Metformin Oral Tablet
sitagliptin Oral Tablet
Linagliptin Oral Tablet
8p7459428 (view patent)2019-02-02NDA022271, NDA022044, NDA022426, NDA201280, NDA201281, NDA202270, NDA202343, NDA203414, NDA206073alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
empagliflozin / Linagliptin Oral Tablet
Metformin / sitagliptin Extended Release Oral Tablet
Metformin / sitagliptin Oral Tablet
Linagliptin / Metformin Oral Tablet
Linagliptin Oral Tablet
9p7807689 (view patent)2028-06-27NDA022271, NDA022426, NDA203414alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
10p8173663 (view patent)2025-03-15NDA022271, NDA022426, NDA203414alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
11p8288539 (view patent)2025-03-15NDA022271, NDA022426, NDA203414alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
12p8697125 (view patent)2029-01-22NDA022271

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1a3768c7e-aa4c-44d3-bc53-43bb7346c0b0 (view SPL)These highlights do not include all the information needed to use NESINA safely and effectively. See full prescribing information for NESINA. NESINA (alogliptin) tabletsInitial U.S. Approval: 2013prescriptionHuman PrescriptionTakeda Pharmaceuticals America, Inc.2015-08-316647640125, 647640250, 647640625

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