linagliptin Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
dipeptidyl aminopeptidase-IV inhibitors 4175 668270-12-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • linagliptin
  • tradjenta
  • BI 1356
  • BI-1356
Linagliptin is an inhibitor of DPP-4, an enzyme that degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Thus, linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation. Both incretin hormones are involved in the physiological regulation of glucose homeostasis. Incretin hormones are secreted at a low basal level throughout the day and levels rise immediately after meal intake. GLP-1 and GIP increase insulin biosynthesis and secretion from pancreatic beta cells in the presence of normal and elevated blood glucose levels. Furthermore, GLP-1 also reduces glucagon secretion from pancreatic alpha cells, resulting in a reduction in hepatic glucose output.
  • Molecular weight: 472.55
  • Formula: C25H28N8O2
  • CLOGP: 1.91
  • LIPINSKI: 0
  • HAC: 10
  • HDO: 1
  • TPSA: 113.48
  • ALOGS: -3.97
  • ROTB: 5
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
5 mg O

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 16 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.90 mL/min/kg Lombardo F, Berellini G, Obach RS
t_half (Half-life) 129 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
May 2, 2011 FDA BOEHRINGER INGELHEIM
July 1, 2011 PMDA Nippon Boehringer Ingelheim Co., Ltd

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Diabetic ketoacidosis 235.57 14.40 109 12877 19806 53316274
Pancreatitis 207.53 14.40 133 12853 46009 53290071
Hypoglycaemia 191.45 14.40 139 12847 58874 53277206
Pemphigoid 190.05 14.40 68 12918 6376 53329704
Blood glucose increased 182.86 14.40 151 12835 77210 53258870
Euglycaemic diabetic ketoacidosis 128.89 14.40 42 12944 2965 53333115
Glycosylated haemoglobin increased 102.17 14.40 52 12934 11603 53324477
Hyperglycaemia 83.82 14.40 73 12913 40011 53296069
Acute kidney injury 83.59 14.40 188 12798 253680 53082400
Renal impairment 78.48 14.40 99 12887 83219 53252861
Hyperlactacidaemia 70.07 14.40 26 12960 2699 53333381
Metabolic acidosis 65.26 14.40 65 12921 42177 53293903
Pancreatitis acute 61.64 14.40 51 12935 26058 53310022
Ketoacidosis 61.08 14.40 27 12959 4399 53331681
Lactic acidosis 58.79 14.40 58 12928 37195 53298885
Pancreatic carcinoma 57.97 14.40 30 12956 6924 53329156
Glomerular filtration rate decreased 57.80 14.40 37 12949 12730 53323350
Diabetes mellitus inadequate control 53.96 14.40 37 12949 14273 53321807
Dermatitis bullous 53.45 14.40 30 12956 8133 53327947
Rheumatoid arthritis 50.67 14.40 8 12978 314523 53021557
Blood glucose abnormal 48.20 14.40 27 12959 7292 53328788
Diabetic metabolic decompensation 47.31 14.40 17 12969 1611 53334469
Hyperkalaemia 45.63 14.40 61 12925 54195 53281885
Fungal infection 43.24 14.40 46 12940 32200 53303880
Pain 40.94 14.40 50 12936 588348 52747732
Renal failure 36.94 14.40 86 12900 118366 53217714
Chronic kidney disease 36.83 14.40 49 12937 43321 53292759
Dizziness 36.57 14.40 183 12803 372076 52964004
Cardiac failure 35.62 14.40 70 12916 85774 53250306
Subarachnoid haemorrhage 31.81 14.40 25 12961 11868 53324212
Blood glucose decreased 29.43 14.40 30 12956 19986 53316094
Shock 29.25 14.40 32 12954 23107 53312973
Diabetes mellitus 28.74 14.40 49 12937 53850 53282230
Insulin-like growth factor decreased 26.82 14.40 8 12978 421 53335659
Drug ineffective 26.54 14.40 106 12880 817139 52518941
Lethargy 26.23 14.40 47 12939 53713 53282367
Mucosal membrane hyperplasia 25.01 14.40 5 12981 46 53336034
Hypoglycaemic encephalopathy 24.95 14.40 7 12979 296 53335784
Urine calcium/creatinine ratio increased 24.05 14.40 6 12980 160 53335920
Lipase increased 23.56 14.40 19 12967 9359 53326721
Urinary tract infection 23.54 14.40 118 12868 239785 53096295
Completed suicide 23.43 14.40 3 12983 138198 53197882
Contraindicated product administered 22.85 14.40 3 12983 135626 53200454
Altered state of consciousness 22.54 14.40 29 12957 24807 53311273
Bite 22.51 14.40 7 12979 424 53335656
Albuminuria 21.90 14.40 6 12980 232 53335848
Blood creatinine increased 21.49 14.40 56 12930 82606 53253474
Vomiting 20.73 14.40 198 12788 496941 52839139
Systemic lupus erythematosus 20.60 14.40 3 12983 125411 53210669
Urethral caruncle 20.12 14.40 5 12981 131 53335949
Decreased appetite 19.18 14.40 103 12883 214871 53121209
Parathyroid hyperplasia 18.84 14.40 5 12981 171 53335909
Pruritus 18.14 14.40 128 12858 293704 53042376
Blood potassium increased 18.05 14.40 22 12964 17819 53318261
Hypomagnesaemia 18.01 14.40 26 12960 24785 53311295
Mesenteric vein thrombosis 16.46 14.40 7 12979 1038 53335042
Hypophagia 16.24 14.40 28 12958 31034 53305046
Food refusal 15.86 14.40 5 12981 317 53335763
Drug intolerance 15.83 14.40 16 12970 205477 53130603
Blood glucose fluctuation 15.36 14.40 11 12975 4540 53331540
Pancreatic enzymes increased 15.35 14.40 6 12980 717 53335363
Arthropathy 14.78 14.40 8 12978 141445 53194635
Pyelonephritis 14.61 14.40 19 12967 16418 53319662

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pemphigoid 459.71 13.76 168 15732 8268 32489358
Pancreatitis 218.38 13.76 167 15733 37984 32459642
Hypoglycaemia 168.90 13.76 168 15732 54214 32443412
Diabetic ketoacidosis 157.32 13.76 102 15798 17830 32479796
Glycosylated haemoglobin increased 148.55 13.76 81 15819 10308 32487318
Blood glucose increased 132.03 13.76 161 15739 65080 32432546
Dermatitis bullous 107.50 13.76 56 15844 6497 32491129
Euglycaemic diabetic ketoacidosis 96.43 13.76 40 15860 2758 32494868
Blood mercury abnormal 75.37 13.76 18 15882 189 32497437
5-hydroxyindolacetic acid in urine increased 73.33 13.76 18 15882 214 32497412
Cardiac failure 66.85 13.76 142 15758 91531 32406095
Pericardial disease 52.53 13.76 15 15885 329 32497297
Cerebral infarction 50.73 13.76 65 15835 27549 32470077
Left ventricular dysfunction 50.09 13.76 40 15860 9655 32487971
Pancreatic carcinoma 48.84 13.76 37 15863 8269 32489357
Low density lipoprotein decreased 46.50 13.76 18 15882 1035 32496591
Pulmonary valve disease 46.24 13.76 13 15887 269 32497357
Pancreatitis acute 45.04 13.76 61 15839 27274 32470352
Diastolic dysfunction 44.03 13.76 29 15871 5195 32492431
Mean platelet volume increased 43.56 13.76 14 15886 463 32497163
Ventricular hyperkinesia 43.26 13.76 12 15888 236 32497390
Hyperglycaemia 42.30 13.76 71 15829 38320 32459306
Ketoacidosis 42.28 13.76 26 15874 4138 32493488
Right atrial enlargement 42.16 13.76 12 15888 260 32497366
Hepatic neoplasm 40.62 13.76 20 15880 2058 32495568
Hypochromasia 39.01 13.76 12 15888 343 32497283
Mitral valve thickening 36.75 13.76 12 15888 418 32497208
Acute kidney injury 36.08 13.76 256 15644 293212 32204414
Stenosis 36.00 13.76 15 15885 1045 32496581
Diabetic nephropathy 34.11 13.76 18 15882 2141 32495485
Rales 33.66 13.76 29 15871 7772 32489854
Blood glucose abnormal 33.09 13.76 25 15875 5563 32492063
Left atrial enlargement 31.79 13.76 12 15888 644 32496982
Renal impairment 31.71 13.76 108 15792 91864 32405762
Left ventricular enlargement 31.66 13.76 12 15888 651 32496975
Haematocrit increased 31.60 13.76 16 15884 1747 32495879
Expired product administered 30.71 13.76 19 15881 3056 32494570
Physical examination abnormal 30.40 13.76 9 15891 225 32497401
Necrotising oesophagitis 29.49 13.76 11 15889 571 32497055
Tricuspid valve incompetence 29.33 13.76 29 15871 9258 32488368
Neoplasm 29.00 13.76 21 15879 4380 32493246
Mucosal dryness 28.65 13.76 13 15887 1114 32496512
Diabetes mellitus 28.39 13.76 66 15834 45107 32452519
Pericardial haemorrhage 28.14 13.76 18 15882 3068 32494558
Diabetes mellitus inadequate control 27.81 13.76 34 15866 13734 32483892
Completed suicide 27.17 13.76 6 15894 92511 32405115
Drug abuse 26.15 13.76 4 15896 80239 32417387
Blood iron decreased 25.56 13.76 20 15880 4684 32492942
Glomerular filtration rate decreased 24.85 13.76 31 15869 12780 32484846
Cardiac discomfort 24.07 13.76 9 15891 470 32497156
Haemoglobin increased 23.31 13.76 16 15884 3066 32494560
Hypovolaemia 23.12 13.76 25 15875 8852 32488774
Amylase increased 23.11 13.76 21 15879 6034 32491592
Mitral valve incompetence 22.71 13.76 32 15868 14839 32482787
Chronic kidney disease 22.53 13.76 56 15844 39919 32457707
Left atrial dilatation 22.41 13.76 13 15887 1859 32495767
Interstitial lung disease 22.10 13.76 76 15824 64925 32432701
Hypohidrosis 21.74 13.76 7 15893 233 32497393
Hypoglycaemic coma 21.66 13.76 14 15886 2429 32495197
Bronchitis viral 21.13 13.76 7 15893 255 32497371
Hypervolaemia 20.99 13.76 14 15886 2560 32495066
Lipase increased 20.57 13.76 24 15876 9233 32488393
Dropped head syndrome 20.31 13.76 6 15894 149 32497477
Neutropenia 20.07 13.76 24 15876 142151 32355475
Bundle branch block left 20.04 13.76 19 15881 5760 32491866
Peak expiratory flow rate decreased 19.90 13.76 6 15894 160 32497466
Poikilocytosis 19.62 13.76 6 15894 168 32497458
Urine ketone body present 19.48 13.76 10 15890 1124 32496502
Hypertensive heart disease 19.09 13.76 13 15887 2459 32495167
Diabetic ketoacidotic hyperglycaemic coma 19.07 13.76 6 15894 185 32497441
Hyperkalaemia 19.05 13.76 76 15824 69674 32427952
Red blood cell count decreased 18.98 13.76 42 15858 27771 32469855
Genital infection fungal 18.77 13.76 6 15894 195 32497431
Echocardiogram abnormal 18.58 13.76 9 15891 894 32496732
Ventricular arrhythmia 18.19 13.76 17 15883 5062 32492564
Mitral valve disease 18.17 13.76 10 15890 1294 32496332
Blindness transient 18.02 13.76 12 15888 2189 32495437
Rhinalgia 17.97 13.76 7 15893 409 32497217
Lactic acidosis 17.87 13.76 46 15854 33490 32464136
General physical health deterioration 17.87 13.76 18 15882 115241 32382385
Electrocardiogram T wave inversion 17.85 13.76 12 15888 2222 32495404
Hepatic function abnormal 17.54 13.76 55 15845 44785 32452841
Blood phosphorus increased 17.40 13.76 13 15887 2844 32494782
Blood chloride increased 16.84 13.76 13 15887 2986 32494640
Death 16.77 13.76 114 15786 382403 32115223
Haemodynamic instability 16.58 13.76 21 15879 8790 32488836
Hyperlactacidaemia 16.55 13.76 13 15887 3061 32494565
Drug ineffective 16.46 13.76 115 15785 383362 32114264
Erythema multiforme 16.24 13.76 21 15879 8971 32488655
Hyperaesthesia teeth 15.98 13.76 7 15893 552 32497074
Supraventricular tachycardia 15.94 13.76 23 15877 10893 32486733
Dust allergy 15.90 13.76 7 15893 558 32497068
High density lipoprotein decreased 15.56 13.76 13 15887 3339 32494287
Product use in unapproved indication 15.46 13.76 12 15888 87192 32410434
Epidermolysis 15.38 13.76 6 15894 352 32497274
Gastric cancer 15.38 13.76 16 15884 5421 32492205
Marasmus 15.08 13.76 7 15893 632 32496994
Metabolic acidosis 15.08 13.76 49 15851 40650 32456976
Acute lung injury 15.00 13.76 9 15891 1369 32496257
Skin disorder 14.94 13.76 24 15876 12480 32485146
Pain 14.75 13.76 45 15855 187511 32310115
Urticaria 14.74 13.76 63 15837 59551 32438075
Respiratory symptom 14.60 13.76 8 15892 1026 32496600
Blood uric acid increased 14.48 13.76 17 15883 6582 32491044
Eosinophil count increased 14.29 13.76 19 15881 8336 32489290
Drug eruption 14.29 13.76 30 15870 19136 32478490
Femoral neck fracture 14.16 13.76 12 15888 3144 32494482
Bronchial hyperreactivity 13.86 13.76 9 15891 1573 32496053

Pharmacologic Action:

SourceCodeDescription
ATC A10BD11 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD19 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD27 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BH05 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Dipeptidyl peptidase 4 (DPP-4) inhibitors
MeSH PA D054873 Dipeptidyl-Peptidase IV Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D006728 Hormones
MeSH PA D007004 Hypoglycemic Agents
MeSH PA D054795 Incretins
MeSH PA D011480 Protease Inhibitors
FDA MoA N0000175912 Dipeptidyl Peptidase 4 Inhibitors
FDA EPC N0000175913 Dipeptidyl Peptidase 4 Inhibitor
CHEBI has role CHEBI:35526 hypoglycemic drug
CHEBI has role CHEBI:68612 DPP-4 inhibitor

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Diabetes mellitus type 2 indication 44054006 DOID:9352
Pancreatitis contraindication 75694006 DOID:4989
Hypoglycemic disorder contraindication 237630007

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.16 Basic
pKa2 6.13 Basic
pKa3 3.79 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
5MG TRADJENTA BOEHRINGER INGELHEIM N201280 May 2, 2011 RX TABLET ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
5MG TRADJENTA BOEHRINGER INGELHEIM N201280 May 2, 2011 RX TABLET ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH INSULIN (WITH OR WITHOUT METFORMIN AND/OR PIOGLITAZONE)
5MG TRADJENTA BOEHRINGER INGELHEIM N201280 May 2, 2011 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH PIOGLITAZONE
5MG TRADJENTA BOEHRINGER INGELHEIM N201280 May 2, 2011 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH SULFONLYUREA
5MG TRADJENTA BOEHRINGER INGELHEIM N201280 May 2, 2011 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
5MG TRADJENTA BOEHRINGER INGELHEIM N201280 May 2, 2011 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH INSULIN (WITH OR WITHOUT METFORMIN AND/OR PIOGLITAZONE)
2.5MG;1GM JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
2.5MG;1GM JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
2.5MG;500MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
2.5MG;500MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
2.5MG;850MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
2.5MG;850MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT INSULIN OR A SULFONYLUREA)
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT METFORMIN)
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT INSULIN OR A SULFONYLUREA)
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT METFORMIN)
2.5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
2.5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND, OPTIONALLY, A SULFONYLUREA
5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND, OPTIONALLY, A SULFONYLUREA
10MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
10MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
12.5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
12.5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
25MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
25MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
5MG TRADJENTA BOEHRINGER INGELHEIM N201280 May 2, 2011 RX TABLET ORAL 8673927 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
2.5MG;1GM JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8673927 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
2.5MG;500MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8673927 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
2.5MG;850MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8673927 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8673927 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 9173859 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8673927 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 9173859 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
2.5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 8673927 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
2.5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 9173859 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 8673927 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 9173859 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
2.5MG;1GM JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 10022379 April 2, 2029 USE OF A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN AND A BASIC AMINO ACID TO TREAT TYPE 2 DIABETES MELLITUS
2.5MG;500MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 10022379 April 2, 2029 USE OF A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN AND A BASIC AMINO ACID TO TREAT TYPE 2 DIABETES MELLITUS
2.5MG;850MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 10022379 April 2, 2029 USE OF A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN AND A BASIC AMINO ACID TO TREAT TYPE 2 DIABETES MELLITUS
2.5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 10022379 April 2, 2029 USE OF A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN AND A BASIC AMINO ACID TO TREAT TYPE 2 DIABETES MELLITUS
5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 10022379 April 2, 2029 USE OF A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN AND A BASIC AMINO ACID TO TREAT TYPE 2 DIABETES MELLITUS
10MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10022379 April 2, 2029 METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
12.5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10022379 April 2, 2029 METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
25MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10022379 April 2, 2029 METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10022379 April 2, 2029 METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
5MG TRADJENTA BOEHRINGER INGELHEIM N201280 May 2, 2011 RX TABLET ORAL 10034877 Aug. 5, 2029 TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT AND FOR WHOM METFORMIN THERAPY IS INAPPROPRIATE BY ADMINISTERING LINAGLIPTIN WITHOUT DOSE ADJUSTMENT
5MG TRADJENTA BOEHRINGER INGELHEIM N201280 May 2, 2011 RX TABLET ORAL 9486526 Aug. 5, 2029 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS WITH SEVERE CHRONIC RENAL IMPAIRMENT AND WHO ARE INELIGIBLE FOR METFORMIN THERAPY BY ADMINISTERING LINAGLIPTIN
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8551957 Oct. 14, 2029 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8551957 Oct. 14, 2029 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
10MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8551957 Oct. 14, 2029 METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
12.5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8551957 Oct. 14, 2029 METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
25MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8551957 Oct. 14, 2029 METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8551957 Oct. 14, 2029 METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
5MG TRADJENTA BOEHRINGER INGELHEIM N201280 May 2, 2011 RX TABLET ORAL 8846695 June 4, 2030 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
2.5MG;1GM JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8846695 June 4, 2030 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
2.5MG;500MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8846695 June 4, 2030 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
2.5MG;850MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8846695 June 4, 2030 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
10MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10406172 June 15, 2030 METHOD OF TREATING A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
12.5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10406172 June 15, 2030 METHOD OF TREATING A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
25MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10406172 June 15, 2030 METHOD OF TREATING A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10406172 June 15, 2030 METHOD OF TREATING A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
5MG TRADJENTA BOEHRINGER INGELHEIM N201280 May 2, 2011 RX TABLET ORAL 8853156 March 5, 2031 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS WITH SEVERE CHRONIC RENAL IMPAIRMENT AND FOR WHOM METFORMIN THERAPY IS INAPPROPRIATE BY ADMINISTERING LINAGLIPTIN
10MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TREATMENT-NAIVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISINGMETFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
10MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
12.5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TREATMENT-NAIVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISINGMETFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
12.5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
25MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TREATMENT-NAIVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISINGMETFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
25MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TREATMENT-NAIVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISINGMETFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
2.5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 9555001 March 6, 2033 METHOD OF TREATING TYPE 2 DIABETES IN PATIENTS WHO HAVE NOT BEEN PREVIOUSLY TREATED WITH AN ANTIHYPERGLYCEMIC AGENT BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
2.5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 9555001 March 6, 2033 METHOD OF TREATING TYPE 2 DIABETES IN PATIENTS WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH ONE OR MORE CONVENTIONAL ANTIHYPERGLYCEMIC AGENTS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 9555001 March 6, 2033 METHOD OF TREATING TYPE 2 DIABETES IN PATIENTS WHO HAVE NOT BEEN PREVIOUSLY TREATED WITH AN ANTIHYPERGLYCEMIC AGENT BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 9555001 March 6, 2033 METHOD OF TREATING TYPE 2 DIABETES IN PATIENTS WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH ONE OR MORE CONVENTIONAL ANTIHYPERGLYCEMIC AGENTS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 10258637 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 10258637 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
10MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10258637 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
10MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR <30 ML/MIN/1.73 M2
12.5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10258637 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
12.5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR <30 ML/MIN/1.73 M2
25MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10258637 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
25MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR <30 ML/MIN/1.73 M2
5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10258637 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR <30 ML/MIN/1.73 M2
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 9949998 June 11, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 9949998 June 11, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
10MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 9949998 June 11, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
12.5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 9949998 June 11, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
25MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 9949998 June 11, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 9949998 June 11, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
5MG TRADJENTA BOEHRINGER INGELHEIM N201280 May 2, 2011 RX TABLET ORAL July 3, 2022 INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
2.5MG;1GM JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL July 3, 2022 INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
2.5MG;500MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL July 3, 2022 INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
2.5MG;850MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL July 3, 2022 INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL July 3, 2022 INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL July 3, 2022 INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
2.5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL July 3, 2022 INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL July 3, 2022 INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
5MG TRADJENTA BOEHRINGER INGELHEIM N201280 May 2, 2011 RX TABLET ORAL March 30, 2023 ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
2.5MG;1GM JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL March 30, 2023 ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
2.5MG;500MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL March 30, 2023 ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
2.5MG;850MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL March 30, 2023 ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL March 30, 2023 ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL March 30, 2023 ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
2.5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL March 30, 2023 ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL March 30, 2023 ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Dipeptidyl peptidase 4 Enzyme INHIBITOR IC50 10 CHEMBL CHEMBL
Dipeptidyl peptidase 9 Enzyme IC50 4 CHEMBL
Muscarinic acetylcholine receptor M1 GPCR IC50 6.53 CHEMBL
Prolyl endopeptidase FAP Enzyme IC50 7.05 CHEMBL
Prolyl endopeptidase FAP Enzyme IC50 6.43 CHEMBL
Dipeptidyl peptidase IV Unclassified IC50 5 CHEMBL

External reference:

IDSource
4030725 VUID
N0000182735 NUI
D09566 KEGG_DRUG
4030725 VANDF
C2746078 UMLSCUI
CHEBI:68610 CHEBI
356 PDB_CHEM_ID
CHEMBL237500 ChEMBL_ID
D000069476 MESH_DESCRIPTOR_UI
DB08882 DRUGBANK_ID
6318 IUPHAR_LIGAND_ID
9039 INN_ID
3X29ZEJ4R2 UNII
10096344 PUBCHEM_CID
1100699 RXNORM
181237 MMSL
27861 MMSL
d07767 MMSL
013732 NDDF
702798009 SNOMEDCT_US
703667006 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Tradjenta HUMAN PRESCRIPTION DRUG LABEL 1 0597-0140 TABLET, FILM COATED 5 mg ORAL NDA 29 sections
Jentadueto HUMAN PRESCRIPTION DRUG LABEL 2 0597-0146 TABLET, FILM COATED 2.50 mg ORAL NDA 32 sections
Jentadueto HUMAN PRESCRIPTION DRUG LABEL 2 0597-0147 TABLET, FILM COATED 2.50 mg ORAL NDA 32 sections
Jentadueto HUMAN PRESCRIPTION DRUG LABEL 2 0597-0148 TABLET, FILM COATED 2.50 mg ORAL NDA 32 sections
Glyxambi HUMAN PRESCRIPTION DRUG LABEL 2 0597-0164 TABLET, FILM COATED 5 mg ORAL NDA 32 sections
Glyxambi HUMAN PRESCRIPTION DRUG LABEL 2 0597-0182 TABLET, FILM COATED 5 mg ORAL NDA 32 sections
Jentadueto XR HUMAN PRESCRIPTION DRUG LABEL 2 0597-0270 TABLET, FILM COATED, EXTENDED RELEASE 2.50 mg ORAL NDA 34 sections
Jentadueto XR HUMAN PRESCRIPTION DRUG LABEL 2 0597-0275 TABLET, FILM COATED, EXTENDED RELEASE 5 mg ORAL NDA 34 sections
Trijardy XR HUMAN PRESCRIPTION DRUG LABEL 3 0597-0380 TABLET, EXTENDED RELEASE 5 mg ORAL NDA 34 sections
Trijardy XR HUMAN PRESCRIPTION DRUG LABEL 3 0597-0385 TABLET, EXTENDED RELEASE 2.50 mg ORAL NDA 34 sections
Trijardy XR HUMAN PRESCRIPTION DRUG LABEL 3 0597-0390 TABLET, EXTENDED RELEASE 5 mg ORAL NDA 34 sections
Trijardy XR HUMAN PRESCRIPTION DRUG LABEL 3 0597-0395 TABLET, EXTENDED RELEASE 2.50 mg ORAL NDA 34 sections
Tradjenta HUMAN PRESCRIPTION DRUG LABEL 1 50090-4383 TABLET, FILM COATED 5 mg ORAL NDA 29 sections
Jentadueto HUMAN PRESCRIPTION DRUG LABEL 2 54868-6461 TABLET, FILM COATED 2.50 mg ORAL NDA 28 sections
Tradjenta HUMAN PRESCRIPTION DRUG LABEL 1 55154-0410 TABLET, FILM COATED 5 mg ORAL NDA 29 sections
Jentadueto HUMAN PRESCRIPTION DRUG LABEL 2 63629-6524 TABLET, FILM COATED 2.50 mg ORAL NDA 31 sections