Linagliptin Oral Tablet

Brand(s)
Tradjenta
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Boehringer Ingelheim Pharmaceuticals, Inc. (2015-08-31)
Oldest Current Product
2011-05-09
License(s)
NDA
RxNORM
ORAL TABLET\LINAGLIPTIN
FDAOB
ORAL\TABLET\LINAGLIPTIN
SPL Active
ORAL\TABLET, FILM COATED\LINAGLIPTIN
SPL Moiety
ORAL\TABLET, FILM COATED\LINAGLIPTIN

product(s) by strength(s)

linagliptin 5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970140TradjentaNDABoehringer Ingelheim Pharmaceuticals, Inc.2011-05-09LINAGLIPTINORALTABLET, FILM COATEDNDA201280c797ea5c-cab7-494b-9044-27eba0cfe40f

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551540410TradjentaNDACardinal Health2011-05-09LINAGLIPTINORALTABLET, FILM COATED005970140NDA201280dfe327e8-f6ab-41e5-bdef-d520118cd83a

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA201280TRADJENTABOEHRINGER INGELHEIM PHARMACEUTICALS INC2011-05-02p8883805, SUBSTANCE
p8846695, METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
p6890898, TREATMENT OF TYPE 2 DIABETES MELLITUS/ METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH INSULIN (WITH OR WITHOUT METFORMIN AND/OR PIOGLITAZONE)
p7407955, SUBSTANCE
p6303661, METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASTE-IV INHIBITOR/ METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH INSULIN (WITH OR WITHOUT METFORMIN AND/OR PIOGLITAZONE)
p8673927, METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
p8178541, METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA/ METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH INSULIN (WITH OR WITHOUT METFORMIN AND/OR PIOGLITAZONE)/ METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH PIOGLITAZONE/ METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH SULFONLYUREA
p7078381, TREATMENT OF TYPE 2 DIABETES MELLITUS/ METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH INSULIN (WITH OR WITHOUT METFORMIN AND/OR PIOGLITAZONE)
p7459428, TREATMENT OF TYPE 2 DIABETES MELLITUS/ METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH INSULIN (WITH OR WITHOUT METFORMIN AND/OR PIOGLITAZONE)
p8853156, METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS WITH SEVERE CHRONIC RENAL IMPAIRMENT AND FOR WHOM METFORMIN THERAPY IS INAPPROPRIATE BY ADMINISTERING LINAGLIPTIN
p8119648, METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASTE-IV INHIBITOR/ METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH INSULIN (WITH OR WITHOUT METFORMIN AND/OR PIOGLITAZONE)
NEW CHEMICAL ENTITY [2016-05-02]
LABELING CHANGES BASED UPON SAFETY AND EFFICACY RESULTS FROM TRIAL 1218.43 [2015-08-13]
LABELING CHANGES BASED UPON SAFETY AND EFFICACY RESULTS FROM TRIAL 1218.36 [2015-08-13]
NDA201280_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA201280_001RXLINAGLIPTIN (5MG)ORALTABLETTrue2011-05-02TRADJENTA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6303661 (view patent)2017-04-24NDA201280, NDA021995, NDA022044, NDA022271, NDA022426, 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
alogliptin Oral Tablet
2p6890898 (view patent)2019-02-02NDA201280, NDA021995, NDA022044, NDA022271, NDA022426, 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
alogliptin Oral Tablet
3p7078381 (view patent)2019-02-02NDA201280, NDA021995, NDA022044, NDA022271, NDA022426, 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
alogliptin Oral Tablet
4p7407955 (view patent)2023-08-12NDA201280, NDA201281, NDA206073empagliflozin / Linagliptin Oral Tablet
Linagliptin / Metformin Oral Tablet
5p7459428 (view patent)2019-02-02NDA201280, NDA022044, NDA022271, NDA022426, 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
alogliptin Oral Tablet
6p8119648 (view patent)2023-08-12NDA201280, NDA201281, NDA206073empagliflozin / Linagliptin Oral Tablet
Linagliptin / Metformin Oral Tablet
7p8178541 (view patent)2023-08-12NDA201280, NDA201281, NDA206073empagliflozin / Linagliptin Oral Tablet
Linagliptin / Metformin Oral Tablet
8p8673927 (view patent)2027-05-04NDA201280, NDA201281, NDA206073empagliflozin / Linagliptin Oral Tablet
Linagliptin / Metformin Oral Tablet
9p8846695 (view patent)2030-06-04NDA201280, NDA201281, NDA206073empagliflozin / Linagliptin Oral Tablet
Linagliptin / Metformin Oral Tablet
10p8853156 (view patent)2031-03-05NDA201280
11p8883805 (view patent)2025-11-26NDA201280, NDA201281, NDA206073empagliflozin / Linagliptin Oral Tablet
Linagliptin / Metformin Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1c797ea5c-cab7-494b-9044-27eba0cfe40f (view SPL)These highlights do not include all the information needed to use TRADJENTA safely and effectively. See full prescribing information for TRADJENTA. Tradjenta (linagliptin) tabletsInitial U.S. Approval: 2011prescriptionHuman PrescriptionBoehringer Ingelheim Pharmaceuticals, Inc.API MANUFACTURE, MANUFACTURE2015-08-3120005970140
2dfe327e8-f6ab-41e5-bdef-d520118cd83a (view SPL)These highlights do not include all the information needed to use TRADJENTA safely and effectively. See full prescribing information for TRADJENTA. Tradjenta (linagliptin) tabletsInitial U.S. Approval: 2011prescriptionHuman PrescriptionCardinal HealthREPACK2014-07-151551540410

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