empagliflozin / Linagliptin Oral Tablet

Brand(s)
Glyxambi
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Boehringer Ingelheim Pharmaceuticals, Inc. (2015-08-31)
Oldest Current Product
2015-01-30
License(s)
NDA
RxNORM
ORAL TABLET\EMPAGLIFLOZIN:LINAGLIPTIN
FDAOB
ORAL\TABLET\EMPAGLIFLOZIN: LINAGLIPTIN
SPL Active
ORAL\TABLET, FILM COATED\EMPAGLIFLOZIN: LINAGLIPTIN
SPL Moiety
ORAL\TABLET, FILM COATED\EMPAGLIFLOZIN: LINAGLIPTIN

product(s) by strength(s)

empagliflozin 10 mg / linagliptin 5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970182GlyxambiNDABoehringer Ingelheim Pharmaceuticals, Inc.2015-01-30EMPAGLIFLOZIN, LINAGLIPTINORALTABLET, FILM COATEDNDA206073ddbab689-f76c-488c-9613-4168d41dd730

empagliflozin 25 mg / linagliptin 5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970164GlyxambiNDABoehringer Ingelheim Pharmaceuticals, Inc.2015-01-30EMPAGLIFLOZIN, LINAGLIPTINORALTABLET, FILM COATEDNDA206073ddbab689-f76c-488c-9613-4168d41dd730

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA206073GLYXAMBIBOEHRINGER INGELHEIM2015-01-30p8883805, SUBSTANCE
p8846695, METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
p7579449
p6890898, METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
p7407955, SUBSTANCE
p6303661, METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
p8673927, METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN, SUBSTANCE
p8178541, METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT INSULIN OR A SULFONYLUREA)/ METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT METFORMIN), SUBSTANCE
p7078381, METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
p7459428, METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
p8119648, METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
p8551957, METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN, SUBSTANCE
p7713938, SUBSTANCE
NEW COMBINATION [2018-01-30]
NEW CHEMICAL ENTITY [2016-05-02]
NEW CHEMICAL ENTITY [2019-08-01]
NDA206073_001, NDA206073_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA206073_001RXLINAGLIPTIN (5MG), EMPAGLIFLOZIN (10MG)ORALTABLETFalse2015-01-30GLYXAMBI
2NDA206073_002RXEMPAGLIFLOZIN (25MG), LINAGLIPTIN (5MG)ORALTABLETTrue2015-01-30GLYXAMBI

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6303661 (view patent)2017-04-24NDA206073, NDA021995, NDA022044, NDA022271, NDA022426, NDA201280, NDA201281, NDA202270, NDA202343, NDA203414alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin 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
2p6890898 (view patent)2019-02-02NDA206073, NDA021995, NDA022044, NDA022271, NDA022426, NDA201280, NDA201281, NDA202270, NDA202343, NDA203414alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin 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
3p7078381 (view patent)2019-02-02NDA206073, NDA021995, NDA022044, NDA022271, NDA022426, NDA201280, NDA201281, NDA202270, NDA202343, NDA203414alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin 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
4p7407955 (view patent)2023-08-12NDA206073, NDA201280, NDA201281Linagliptin / Metformin Oral Tablet
Linagliptin Oral Tablet
5p7459428 (view patent)2019-02-02NDA206073, NDA022044, NDA022271, NDA022426, NDA201280, NDA201281, NDA202270, NDA202343, NDA203414alogliptin / pioglitazone Oral Tablet
alogliptin / Metformin Oral Tablet
Metformin / sitagliptin Extended Release Oral Tablet
Metformin / sitagliptin Oral Tablet
Linagliptin / Metformin Oral Tablet
alogliptin Oral Tablet
Linagliptin Oral Tablet
6p7579449 (view patent)2025-11-05NDA206073, NDA204629, NDA206111empagliflozin / Metformin Oral Tablet
7p7713938 (view patent)2027-04-15NDA206073, NDA204629, NDA206111empagliflozin / Metformin Oral Tablet
8p8119648 (view patent)2023-08-12NDA206073, NDA201280, NDA201281Linagliptin / Metformin Oral Tablet
Linagliptin Oral Tablet
9p8178541 (view patent)2023-08-12NDA206073, NDA201280, NDA201281Linagliptin / Metformin Oral Tablet
Linagliptin Oral Tablet
10p8551957 (view patent)2029-10-19NDA206073
11p8673927 (view patent)2027-05-04NDA206073, NDA201280, NDA201281Linagliptin / Metformin Oral Tablet
Linagliptin Oral Tablet
12p8846695 (view patent)2030-06-04NDA206073, NDA201280, NDA201281Linagliptin / Metformin Oral Tablet
Linagliptin Oral Tablet
13p8883805 (view patent)2025-11-26NDA206073, NDA201280, NDA201281Linagliptin / Metformin Oral Tablet
Linagliptin Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1ddbab689-f76c-488c-9613-4168d41dd730 (view SPL)These highlights do not include all the information needed to use GLYXAMBI safely and effectively. See full prescribing information for GLYXAMBI. GLYXAMBI (empagliflozin and linagliptin) tablets, for oral useInitial U.S. Approval: 2015prescriptionHuman PrescriptionBoehringer Ingelheim Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-08-312005970164, 005970182

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