Linagliptin / Metformin Oral Tablet

Brand(s)
Jentadueto
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Boehringer Ingelheim Pharmaceuticals, Inc. (2015-08-31)
Oldest Current Product
2012-02-13
License(s)
NDA
RxNORM
ORAL TABLET\LINAGLIPTIN:METFORMIN
FDAOB
ORAL\TABLET\LINAGLIPTIN: METFORMIN HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\LINAGLIPTIN: METFORMIN HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\LINAGLIPTIN: METFORMIN

product(s) by strength(s)

linagliptin 2.5 mg / metformin hydrochloride 1000 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970148JentaduetoNDABoehringer Ingelheim Pharmaceuticals, Inc.2012-02-13LINAGLIPTIN, METFORMIN HYDROCHLORIDEORALTABLET, FILM COATEDNDA201281f6dd9b86-0d18-95d4-2bc7-05591bfdd597

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548686461JentaduetoNDAPhysicians Total Care, Inc.2012-02-13LINAGLIPTIN, METFORMIN HYDROCHLORIDEORALTABLET, FILM COATED005970148NDA2012819822b5fa-6024-445a-a36d-a26106c69845

linagliptin 2.5 mg / metformin hydrochloride 500 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970146JentaduetoNDABoehringer Ingelheim Pharmaceuticals, Inc.2012-02-13LINAGLIPTIN, METFORMIN HYDROCHLORIDEORALTABLET, FILM COATEDNDA201281f6dd9b86-0d18-95d4-2bc7-05591bfdd597

linagliptin 2.5 mg / metformin hydrochloride 850 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970147JentaduetoNDABoehringer Ingelheim Pharmaceuticals, Inc.2012-02-13LINAGLIPTIN, METFORMIN HYDROCHLORIDEORALTABLET, FILM COATEDNDA201281f6dd9b86-0d18-95d4-2bc7-05591bfdd597

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA201281JENTADUETOBOEHRINGER INGELHEIM PHARMACEUTICALS INC2012-01-30p9155705, SUBSTANCE
p8883805, SUBSTANCE
p8846695, METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
p6890898, METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH METFORMIN
p7407955, SUBSTANCE
p6303661, METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
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, SUBSTANCE
p7078381, METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH METFORMIN
p7459428, METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH METFORMIN
p8119648, METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
INFORMATION ADDED TO THE CLINICAL STUDIES SECTION ON INITIAL COMBINATION THERAPY WITH LINAGLIPTIN AND METFORMIN VS. LINAGLIPTIN MONOTHERAPY IN TREATMENT NAIVE PATIENTS [2017-07-30]
NEW COMBINATION [2015-01-30]
NEW CHEMICAL ENTITY [2016-05-02]
NDA201281_001, NDA201281_002, NDA201281_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA201281_001RXLINAGLIPTIN (2.5MG), METFORMIN HYDROCHLORIDE (500MG)ORALTABLETFalse2012-01-30JENTADUETO
2NDA201281_002RXLINAGLIPTIN (2.5MG), METFORMIN HYDROCHLORIDE (850MG)ORALTABLETFalse2012-01-30JENTADUETO
3NDA201281_003RXMETFORMIN HYDROCHLORIDE (1GM), LINAGLIPTIN (2.5MG)ORALTABLETTrue2012-01-30JENTADUETO

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6303661 (view patent)2017-04-24NDA201281, NDA021995, NDA022044, NDA022271, NDA022426, NDA201280, 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
sitagliptin Oral Tablet
alogliptin Oral Tablet
Linagliptin Oral Tablet
2p6890898 (view patent)2019-02-02NDA201281, NDA021995, NDA022044, NDA022271, NDA022426, NDA201280, 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
sitagliptin Oral Tablet
alogliptin Oral Tablet
Linagliptin Oral Tablet
3p7078381 (view patent)2019-02-02NDA201281, NDA021995, NDA022044, NDA022271, NDA022426, NDA201280, 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
sitagliptin Oral Tablet
alogliptin Oral Tablet
Linagliptin Oral Tablet
4p7407955 (view patent)2023-08-12NDA201281, NDA201280, NDA206073empagliflozin / Linagliptin Oral Tablet
Linagliptin Oral Tablet
5p7459428 (view patent)2019-02-02NDA201281, NDA022044, NDA022271, NDA022426, NDA201280, 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
alogliptin Oral Tablet
Linagliptin Oral Tablet
6p8119648 (view patent)2023-08-12NDA201281, NDA201280, NDA206073empagliflozin / Linagliptin Oral Tablet
Linagliptin Oral Tablet
7p8178541 (view patent)2023-08-12NDA201281, NDA201280, NDA206073empagliflozin / Linagliptin Oral Tablet
Linagliptin Oral Tablet
8p8673927 (view patent)2027-05-04NDA201281, NDA201280, NDA206073empagliflozin / Linagliptin Oral Tablet
Linagliptin Oral Tablet
9p8846695 (view patent)2030-06-04NDA201281, NDA201280, NDA206073empagliflozin / Linagliptin Oral Tablet
Linagliptin Oral Tablet
10p8883805 (view patent)2025-11-26NDA201281, NDA201280, NDA206073empagliflozin / Linagliptin Oral Tablet
Linagliptin Oral Tablet
11p9155705 (view patent)2030-05-21NDA201281

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
19822b5fa-6024-445a-a36d-a26106c69845 (view SPL)These highlights do not include all the information needed to use JENTADUETO safely and effectively. See full prescribing information for JENTADUETO. Jentadueto (linagliptin and metformin hydrochloride) tabletsInitial U.S. Approval: 2012prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2015-05-062548686461
2f6dd9b86-0d18-95d4-2bc7-05591bfdd597 (view SPL)These highlights do not include all the information needed to use JENTADUETO safely and effectively. See full prescribing information for JENTADUETO. Jentadueto (linagliptin and metformin hydrochloride) tabletsInitial U.S. Approval: 2012prescriptionHuman PrescriptionBoehringer Ingelheim Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-08-3128005970146, 005970147, 005970148

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