linagliptin 🐶 Veterinary Use | 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: 2.19
  • 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
Hypoglycaemia 211.78 15.23 141 12665 55674 56223587
Pemphigoid 207.72 15.23 71 12735 6229 56273032
Pancreatitis 164.03 15.23 111 12695 44969 56234292
Blood glucose increased 151.32 15.23 130 12676 75021 56204240
Acute kidney injury 112.03 15.23 198 12608 240565 56038696
Glycosylated haemoglobin increased 95.70 15.23 48 12758 11117 56268144
Dermatitis bullous 93.92 15.23 42 12764 7531 56271730
Renal impairment 91.54 15.23 102 12704 80611 56198650
Hyperglycaemia 82.67 15.23 69 12737 38212 56241049
Hyperlactacidaemia 65.60 15.23 24 12782 2564 56276697
Subarachnoid haemorrhage 64.14 15.23 37 12769 11310 56267951
Diabetes mellitus inadequate control 59.49 15.23 38 12768 13942 56265319
Diabetic ketoacidosis 58.14 15.23 42 12764 18829 56260432
Rheumatoid arthritis 57.86 15.23 9 12797 382595 55896666
Euglycaemic diabetic ketoacidosis 57.24 15.23 23 12783 3166 56276095
Hyperkalaemia 57.14 15.23 64 12742 50801 56228460
Metabolic acidosis 56.23 15.23 57 12749 40397 56238864
Pancreatic carcinoma 55.85 15.23 29 12777 7212 56272049
Cardiac failure 53.76 15.23 79 12727 82014 56197247
Chronic kidney disease 52.60 15.23 56 12750 42000 56237261
Blood glucose abnormal 50.23 15.23 27 12779 7201 56272060
Pancreatitis acute 49.55 15.23 43 12763 25081 56254180
Cystostomy 48.86 15.23 9 12797 55 56279206
Pain 47.17 15.23 49 12757 663135 55616126
Lactic acidosis 44.08 15.23 47 12759 35299 56243962
Glomerular filtration rate decreased 43.93 15.23 30 12776 12299 56266962
Diabetic metabolic decompensation 41.64 15.23 15 12791 1533 56277728
Renal failure 40.22 15.23 82 12724 110418 56168843
Drug ineffective 39.65 15.23 95 12711 918894 55360367
Dizziness 36.09 15.23 175 12631 375965 55903296
Diabetes mellitus 33.42 15.23 50 12756 52685 56226576
Blood glucose decreased 32.35 15.23 30 12776 19057 56260204
Systemic lupus erythematosus 30.18 15.23 3 12803 180075 56099186
Urinary tract infection 29.92 15.23 121 12685 240392 56038869
Rhabdomyolysis 29.34 15.23 41 12765 40617 56238644
Lethargy 28.72 15.23 46 12760 51395 56227866
Ketoacidosis 27.69 15.23 15 12791 4060 56275201
Shock 27.28 15.23 29 12777 21699 56257562
Contraindicated product administered 26.75 15.23 5 12801 186281 56092980
Urine calcium/creatinine ratio increased 26.39 15.23 6 12800 114 56279147
Blood creatinine increased 26.24 15.23 57 12749 80134 56199127
Altered state of consciousness 25.89 15.23 29 12777 22992 56256269
Hypoglycaemic encephalopathy 25.72 15.23 7 12799 283 56278978
Mucosal membrane hyperplasia 25.65 15.23 5 12801 43 56279218
Arthropathy 25.51 15.23 7 12799 200268 56078993
Decreased appetite 24.68 15.23 107 12699 219124 56060137
Drug intolerance 24.47 15.23 15 12791 264803 56014458
Hypomagnesaemia 23.94 15.23 29 12777 24986 56254275
Insulin-like growth factor decreased 23.63 15.23 7 12799 385 56278876
Therapeutic product effect decreased 23.38 15.23 5 12801 169447 56109814
Albuminuria 23.37 15.23 6 12800 193 56279068
Bite 23.14 15.23 7 12799 414 56278847
Pemphigus 23.04 15.23 4 12802 157208 56122053
Pyelonephritis 23.03 15.23 23 12783 16001 56263260
Urethral caruncle 22.57 15.23 5 12801 84 56279177
Wound 21.55 15.23 3 12803 138801 56140460
Infusion related reaction 20.48 15.23 11 12795 208920 56070341
Parathyroid hyperplasia 20.04 15.23 5 12801 143 56279118
Lipase increased 18.98 15.23 16 12790 8963 56270298
Glossodynia 18.19 15.23 6 12800 152452 56126809
Blood potassium increased 18.15 15.23 21 12785 17240 56262021
Discomfort 17.96 15.23 5 12801 141756 56137505
Post procedural infection 17.93 15.23 15 12791 8317 56270944
Mesenteric vein thrombosis 17.24 15.23 7 12799 990 56278271
Tubulointerstitial nephritis 17.06 15.23 20 12786 16645 56262616
Vomiting 16.31 15.23 179 12627 498049 55781212
Pancreatic enzymes increased 16.05 15.23 6 12800 681 56278580
Food refusal 15.84 15.23 5 12801 341 56278920
Drug hypersensitivity 15.65 15.23 24 12782 275181 56004080
Toxic encephalopathy 15.57 15.23 12 12794 5926 56273335
Alopecia 15.38 15.23 27 12779 293431 55985830
Staphylococcal sepsis 15.34 15.23 13 12793 7336 56271925

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 492.35 14.43 178 16076 8093 31672997
Pancreatitis 177.79 14.43 147 16107 35624 31645466
Hypoglycaemia 165.83 14.43 165 16089 50781 31630309
Dermatitis bullous 152.36 14.43 71 16183 6174 31674916
Glycosylated haemoglobin increased 128.75 14.43 75 16179 10325 31670765
Blood glucose increased 124.65 14.43 155 16099 60928 31620162
Blood mercury abnormal 78.36 14.43 19 16235 203 31680887
5-hydroxyindolacetic acid in urine increased 76.49 14.43 19 16235 226 31680864
Cardiac failure 73.26 14.43 146 16108 85807 31595283
Left ventricular dysfunction 67.40 14.43 48 16206 9309 31671781
Pericardial disease 66.98 14.43 19 16235 387 31680703
Pulmonary valve disease 61.96 14.43 17 16237 305 31680785
Euglycaemic diabetic ketoacidosis 55.94 14.43 28 16226 2846 31678244
Diastolic dysfunction 51.94 14.43 33 16221 5302 31675788
Diabetic ketoacidosis 51.69 14.43 53 16201 16852 31664238
Cerebral infarction 49.85 14.43 64 16190 25913 31655177
Low density lipoprotein decreased 49.08 14.43 19 16235 1041 31680049
Acute kidney injury 46.66 14.43 273 15981 279441 31401649
Physical examination abnormal 44.88 14.43 13 16241 286 31680804
Ventricular hyperkinesia 44.39 14.43 12 16242 203 31680887
Hyperglycaemia 43.84 14.43 72 16182 36404 31644686
Stenosis 43.32 14.43 18 16236 1187 31679903
Right atrial enlargement 43.14 14.43 12 16242 227 31680863
Renal impairment 43.10 14.43 119 16135 86230 31594860
Mean platelet volume increased 41.91 14.43 14 16240 499 31680591
Rales 41.80 14.43 35 16219 8604 31672486
Hepatic neoplasm 41.27 14.43 20 16234 1895 31679195
Diabetic nephropathy 40.25 14.43 20 16234 2001 31679089
Hypochromasia 40.09 14.43 12 16242 297 31680793
Pancreatitis acute 38.42 14.43 56 16198 25544 31655546
Pancreatic carcinoma 37.85 14.43 33 16221 8567 31672523
Mitral valve thickening 37.52 14.43 12 16242 372 31680718
Tricuspid valve incompetence 37.10 14.43 33 16221 8796 31672294
Cardiac discomfort 36.97 14.43 13 16241 542 31680548
Blood glucose abnormal 35.18 14.43 26 16228 5337 31675753
Diabetes mellitus 34.66 14.43 71 16183 42485 31638605
Drug abuse 33.93 14.43 3 16251 87755 31593335
Chronic kidney disease 32.89 14.43 65 16189 37910 31643180
Left ventricular enlargement 30.81 14.43 12 16242 668 31680422
Mitral valve incompetence 30.81 14.43 37 16217 13996 31667094
Mucosal dryness 30.65 14.43 14 16240 1161 31679929
Echocardiogram abnormal 30.45 14.43 13 16241 917 31680173
Hyperkalaemia 30.43 14.43 87 16167 64264 31616826
Bundle branch block left 30.15 14.43 24 16230 5494 31675596
Aortic valve incompetence 30.07 14.43 24 16230 5517 31675573
Necrotising oesophagitis 30.02 14.43 11 16243 517 31680573
Expired product administered 29.96 14.43 19 16235 3042 31678048
Haematocrit increased 29.78 14.43 16 16238 1881 31679209
Mitral valve disease 29.68 14.43 14 16240 1249 31679841
Neoplasm 29.55 14.43 22 16232 4564 31676526
Hepatojugular reflux 29.32 14.43 11 16243 553 31680537
Electrocardiogram Q wave abnormal 29.15 14.43 10 16244 387 31680703
Left atrial enlargement 29.15 14.43 12 16242 773 31680317
Pericardial haemorrhage 27.73 14.43 18 16236 2999 31678091
Occult blood 27.72 14.43 11 16243 644 31680446
Hypoglycaemic coma 27.43 14.43 16 16238 2205 31678885
Completed suicide 26.66 14.43 7 16247 91507 31589583
Hypohidrosis 26.35 14.43 8 16246 208 31680882
Ventricular arrhythmia 26.14 14.43 21 16233 4870 31676220
Acute lung injury 25.85 14.43 13 16241 1334 31679756
Bronchitis viral 25.42 14.43 8 16246 235 31680855
Peak expiratory flow rate decreased 25.39 14.43 7 16247 128 31680962
Left atrial dilatation 25.33 14.43 14 16240 1741 31679349
Interstitial lung disease 25.23 14.43 79 16175 61324 31619766
Dyspnoea at rest 25.16 14.43 18 16236 3513 31677577
Hypovolaemia 25.14 14.43 26 16228 8346 31672744
Haemoglobin increased 24.75 14.43 17 16237 3109 31677981
Helicobacter gastritis 24.17 14.43 12 16242 1198 31679892
Diabetes mellitus inadequate control 23.82 14.43 31 16223 12710 31668380
Poikilocytosis 23.51 14.43 7 16247 170 31680920
Blood iron decreased 22.69 14.43 19 16235 4671 31676419
Eosinophilic pneumonia 22.56 14.43 16 16238 3081 31678009
Left ventricular hypertrophy 22.43 14.43 23 16231 7309 31673781
Amylase increased 22.13 14.43 20 16234 5442 31675648
Off label use 21.75 14.43 98 16156 347176 31333914
Drug ineffective 21.69 14.43 117 16137 395456 31285634
Rhinalgia 21.54 14.43 8 16246 391 31680699
Lactic acidosis 21.11 14.43 49 16205 31888 31649202
Red blood cell count decreased 20.97 14.43 44 16210 26763 31654327
Glomerular filtration rate decreased 20.84 14.43 28 16226 11837 31669253
Carotid artery stenosis 20.77 14.43 18 16236 4634 31676456
Supraventricular tachycardia 20.72 14.43 26 16228 10281 31670809
Electrocardiogram T wave inversion 20.69 14.43 13 16241 2047 31679043
Respiratory symptom 20.46 14.43 11 16243 1295 31679795
Product use in unapproved indication 20.17 14.43 13 16241 99158 31581932
Metabolic acidosis 20.17 14.43 55 16199 39522 31641568
Hypertensive heart disease 20.01 14.43 13 16241 2168 31678922
Diabetic ketoacidotic hyperglycaemic coma 19.99 14.43 6 16248 150 31680940
Carotid arteriosclerosis 19.98 14.43 12 16242 1745 31679345
Hyperaesthesia teeth 19.74 14.43 8 16246 495 31680595
Syncope 19.54 14.43 91 16163 85091 31595999
Bronchial hyperreactivity 19.42 14.43 11 16243 1434 31679656
Lipase increased 18.89 14.43 23 16231 8820 31672270
Dust allergy 18.52 14.43 8 16246 581 31680509
Blindness transient 18.45 14.43 12 16242 2005 31679085
Hepatic function abnormal 17.82 14.43 54 16200 41168 31639922
Pain 17.63 14.43 44 16210 186715 31494375
Hyperlactacidaemia 17.29 14.43 13 16241 2737 31678353
Erythema multiforme 17.25 14.43 21 16233 8050 31673040
Skin disorder 17.18 14.43 26 16228 12255 31668835
Blood chloride increased 17.12 14.43 13 16241 2778 31678312
Sputum discoloured 16.76 14.43 19 16235 6757 31674333
Epidermolysis 16.34 14.43 6 16248 284 31680806
Intestinal obstruction 16.31 14.43 34 16220 20576 31660514
Haemodynamic instability 16.24 14.43 21 16233 8554 31672536
Eosinophil count increased 16.22 14.43 20 16234 7771 31673319
Marasmus 16.12 14.43 7 16247 515 31680575
High density lipoprotein decreased 15.73 14.43 13 16241 3137 31677953
Oral mucosal blistering 15.25 14.43 10 16244 1695 31679395
Latent autoimmune diabetes in adults 15.18 14.43 4 16250 61 31681029
Incontinence 14.87 14.43 16 16238 5370 31675720
Renal failure 14.76 14.43 111 16143 123219 31557871
Ventricular hypokinesia 14.56 14.43 15 16239 4791 31676299
Anaemia macrocytic 14.55 14.43 12 16242 2888 31678202
Haematocrit decreased 14.54 14.43 41 16213 30020 31651070
Immune-mediated myositis 14.49 14.43 10 16244 1842 31679248

FDA Adverse Event Reporting System (Geriatric)

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 675.67 12.74 238 26358 13784 70888064
Hypoglycaemia 335.71 12.74 280 26316 94084 70807764
Pancreatitis 224.87 12.74 187 26409 62481 70839367
Blood glucose increased 188.21 12.74 212 26384 102770 70799078
Dermatitis bullous 187.90 12.74 93 26503 12664 70889184
Glycosylated haemoglobin increased 179.70 12.74 100 26496 17291 70884557
Acute kidney injury 159.19 12.74 463 26133 474161 70427687
Cardiac failure 132.92 12.74 212 26384 143329 70758519
Diabetic ketoacidosis 114.97 12.74 95 26501 31417 70870431
Renal impairment 111.12 12.74 196 26400 143741 70758107
Euglycaemic diabetic ketoacidosis 110.41 12.74 51 26545 5956 70895892
Hyperglycaemia 102.79 12.74 124 26472 64548 70837300
Chronic kidney disease 92.06 12.74 114 26482 60943 70840905
Blood mercury abnormal 84.27 12.74 19 26577 203 70901645
Pancreatic carcinoma 83.58 12.74 55 26541 12849 70888999
5-hydroxyindolacetic acid in urine increased 82.25 12.74 19 26577 228 70901620
Hyperkalaemia 80.74 12.74 144 26452 106447 70795401
Diabetes mellitus inadequate control 77.90 12.74 66 26530 22579 70879269
Pain 71.97 12.74 78 26518 628738 70273110
Pulmonary valve disease 69.17 12.74 17 26579 270 70901578
Hyperlactacidaemia 68.86 12.74 35 26561 5037 70896811
Metabolic acidosis 67.63 12.74 109 26487 74237 70827611
Pericardial disease 67.39 12.74 19 26577 524 70901324
Drug ineffective 66.76 12.74 160 26436 939592 69962256
Diabetes mellitus 64.92 12.74 105 26491 71719 70830129
Rheumatoid arthritis 62.82 12.74 16 26580 291789 70610059
Completed suicide 60.79 12.74 7 26589 227128 70674720
Lactic acidosis 58.68 12.74 95 26501 64929 70836919
Glomerular filtration rate decreased 58.42 12.74 54 26542 20702 70881146
Pancreatitis acute 58.06 12.74 78 26518 45146 70856702
Left ventricular dysfunction 57.02 12.74 50 26546 17907 70883941
Cerebral infarction 54.93 12.74 74 26522 42935 70858913
Low density lipoprotein decreased 53.69 12.74 19 26577 1111 70900737
Renal failure 51.53 12.74 172 26424 188898 70712950
Blood glucose abnormal 50.66 12.74 36 26560 9521 70892327
Physical examination abnormal 49.53 12.74 13 26583 272 70901576
Diastolic dysfunction 46.50 12.74 34 26562 9399 70892449
Diabetic nephropathy 46.19 12.74 22 26574 2751 70899097
Ventricular hyperkinesia 45.27 12.74 12 26584 261 70901587
Right atrial enlargement 42.81 12.74 12 26584 324 70901524
Drug abuse 40.77 12.74 4 26592 147252 70754596
Mitral valve thickening 40.39 12.74 12 26584 400 70901448
Interstitial lung disease 39.64 12.74 107 26489 104578 70797270
Stenosis 39.28 12.74 18 26578 2063 70899785
Subarachnoid haemorrhage 38.75 12.74 42 26554 19462 70882386
Product use in unapproved indication 38.18 12.74 15 26581 207463 70694385
Cystostomy 37.78 12.74 8 26588 62 70901786
Hepatic neoplasm 37.48 12.74 20 26576 3180 70898668
Therapeutic product effect decreased 36.81 12.74 5 26591 143013 70758835
Mean platelet volume increased 36.11 12.74 14 26582 1058 70900790
Altered state of consciousness 35.45 12.74 58 26538 39964 70861884
Ketoacidosis 35.38 12.74 26 26570 7243 70894605
Cardiac discomfort 34.91 12.74 14 26582 1157 70900691
Treatment failure 34.90 12.74 6 26590 144136 70757712
Hypochromasia 34.58 12.74 12 26584 662 70901186
Synovitis 34.52 12.74 4 26592 129224 70772624
Haemoglobin increased 34.11 12.74 23 26573 5592 70896256
Left ventricular enlargement 33.89 12.74 12 26584 703 70901145
Left ventricular hypertrophy 33.58 12.74 29 26567 10173 70891675
Diabetic metabolic decompensation 32.75 12.74 18 26578 3034 70898814
Arthropathy 32.71 12.74 8 26588 150049 70751799
Blood iron decreased 32.56 12.74 32 26564 13229 70888619
Rales 32.48 12.74 36 26560 17099 70884749
Hepatojugular reflux 31.80 12.74 11 26585 601 70901247
Hypoglycaemic coma 31.72 12.74 20 26576 4341 70897507
Infusion related reaction 30.67 12.74 18 26578 197516 70704332
Necrotising oesophagitis 30.16 12.74 11 26585 702 70901146
Haemodynamic instability 29.86 12.74 33 26563 15625 70886223
Tricuspid valve incompetence 29.66 12.74 35 26561 17782 70884066
Haematocrit increased 29.61 12.74 18 26578 3664 70898184
Left atrial enlargement 29.23 12.74 12 26584 1054 70900794
Expired product administered 29.11 12.74 22 26574 6391 70895457
Electrocardiogram Q wave abnormal 28.74 12.74 10 26586 556 70901292
Aortic valve incompetence 28.68 12.74 25 26571 8879 70892969
Hepatic function abnormal 28.28 12.74 72 26524 67924 70833924
End stage renal disease 27.59 12.74 27 26569 11106 70890742
Drug hypersensitivity 27.31 12.74 35 26561 262424 70639424
Pericardial haemorrhage 27.17 12.74 18 26578 4250 70897598
Lipase increased 27.14 12.74 31 26565 15215 70886633
Hypohidrosis 26.50 12.74 8 26588 282 70901566
Mitral valve incompetence 25.40 12.74 40 26556 26688 70875160
Bundle branch block left 25.36 12.74 25 26571 10374 70891474
Neoplasm 25.27 12.74 22 26574 7802 70894046
Ventricular arrhythmia 25.25 12.74 22 26574 7808 70894040
Echocardiogram abnormal 24.97 12.74 13 26583 1966 70899882
Blood creatinine increased 24.92 12.74 113 26483 142888 70758960
Arthralgia 24.74 12.74 101 26495 503289 70398559
Headache 24.62 12.74 123 26473 580282 70321566
Renal disorder 24.56 12.74 48 26548 37961 70863887
Diabetic ketoacidotic hyperglycaemic coma 23.92 12.74 7 26589 221 70901627
Amylase increased 23.89 12.74 24 26572 10184 70891664
Left atrial dilatation 23.09 12.74 14 26582 2835 70899013
Mucosal membrane hyperplasia 23.05 12.74 5 26591 44 70901804
Mitral valve disease 22.69 12.74 14 26582 2926 70898922
Syncope 22.52 12.74 122 26474 165587 70736261
Carotid arteriosclerosis 22.48 12.74 13 26583 2414 70899434
Occult blood 22.31 12.74 11 26585 1483 70900365
Urine calcium/creatinine ratio increased 22.16 12.74 6 26590 142 70901706
Erythema multiforme 21.91 12.74 29 26567 16535 70885313
Sputum discoloured 21.91 12.74 31 26565 18820 70883028
Blood phosphorus increased 21.79 12.74 19 26577 6751 70895097
Diabetic foot 21.62 12.74 14 26582 3180 70898668
Mucosal dryness 21.54 12.74 14 26582 3202 70898646
Poikilocytosis 21.37 12.74 7 26589 323 70901525
Acute myocardial infarction 21.34 12.74 68 26528 72819 70829029
Systemic lupus erythematosus 21.12 12.74 6 26590 101896 70799952
Acute lung injury 20.73 12.74 13 26583 2796 70899052
Urethral caruncle 20.67 12.74 5 26591 74 70901774
Marasmus 20.63 12.74 9 26587 919 70900929
Hypoglycaemic encephalopathy 20.44 12.74 8 26588 620 70901228
Red blood cell count decreased 20.42 12.74 54 26542 52107 70849741
Depression 20.21 12.74 27 26569 198947 70702901
Helicobacter gastritis 20.12 12.74 12 26584 2359 70899489
Electrocardiogram T wave inversion 20.10 12.74 16 26580 5015 70896833
Alopecia 20.09 12.74 27 26569 198463 70703385
Peak expiratory flow rate decreased 20.02 12.74 8 26588 655 70901193
Decreased appetite 19.97 12.74 188 26408 304592 70597256
Dyspnoea at rest 19.69 12.74 18 26578 6801 70895047
Hypovolaemia 19.63 12.74 27 26569 15966 70885882
Supraventricular tachycardia 19.43 12.74 30 26566 19680 70882168
Drug intolerance 18.77 12.74 35 26561 225652 70676196
Bite 18.75 12.74 7 26589 477 70901371
Blood uric acid increased 18.73 12.74 20 26576 9109 70892739
Contraindicated product administered 18.55 12.74 14 26582 134598 70767250
Pyelonephritis 18.26 12.74 28 26568 18261 70883587
Neutropenia 17.96 12.74 44 26552 257112 70644736
Rhinalgia 17.71 12.74 9 26587 1295 70900553
Rhabdomyolysis 17.68 12.74 77 26519 95683 70806165
Eosinophil count increased 17.64 12.74 25 26571 15197 70886651
Insulin-like growth factor decreased 17.53 12.74 7 26589 572 70901276
Gastric cancer 17.29 12.74 19 26577 8936 70892912
Sinusitis 17.14 12.74 23 26573 169172 70732676
Hypersensitivity 17.10 12.74 38 26558 229774 70672074
Cardiomegaly 17.09 12.74 32 26564 24513 70877335
Melaena 16.89 12.74 53 26543 56302 70845546
Carotid artery stenosis 16.82 12.74 18 26578 8218 70893630
Hypertensive heart disease 16.82 12.74 13 26583 3903 70897945
Antibiotic level above therapeutic 16.82 12.74 7 26589 636 70901212
Parathyroid hyperplasia 16.79 12.74 5 26591 168 70901680
Wound 16.78 12.74 8 26588 98724 70803124
Psoriasis 16.69 12.74 8 26588 98425 70803423
Albuminuria 16.65 12.74 7 26589 653 70901195
Bronchial hyperreactivity 16.53 12.74 11 26585 2615 70899233
Arteriosclerosis coronary artery 16.43 12.74 25 26571 16190 70885658
Pneumonia 16.38 12.74 314 26282 595918 70305930
High density lipoprotein decreased 16.24 12.74 13 26583 4106 70897742
Bronchitis viral 16.24 12.74 8 26588 1077 70900771
Blood glucose decreased 16.21 12.74 31 26565 24128 70877720
Discomfort 15.81 12.74 10 26586 105426 70796422
Dust allergy 15.58 12.74 8 26588 1176 70900672
Nephrogenic anaemia 15.52 12.74 12 26584 3606 70898242
Haematocrit decreased 15.49 12.74 52 26544 57206 70844642
Femoral neck fracture 15.39 12.74 18 26578 9055 70892793
Urinary tract infection 15.08 12.74 151 26445 248618 70653230
Oesophageal varices haemorrhage 14.99 12.74 12 26584 3791 70898057
Latent autoimmune diabetes in adults 14.92 12.74 4 26592 91 70901757
Epidermolysis 14.91 12.74 6 26590 500 70901348
Glossodynia 14.71 12.74 7 26589 86480 70815368
Drug eruption 14.57 12.74 40 26556 39456 70862392
Incontinence 14.52 12.74 21 26575 13007 70888841
Anxiety 14.38 12.74 39 26557 220291 70681557
Hyperuricaemia 14.20 12.74 19 26577 10947 70890901
Blood chloride increased 14.16 12.74 13 26583 4940 70896908
Blood triglycerides increased 14.15 12.74 26 26570 19638 70882210
Urine ketone body present 14.04 12.74 11 26585 3368 70898480
Pruritus 13.95 12.74 194 26402 345366 70556482
Serum ferritin increased 13.86 12.74 17 26579 8988 70892860
Fatigue 13.76 12.74 222 26374 824097 70077751
Adenosquamous cell lung cancer 13.49 12.74 3 26593 30 70901818
Ureteric cancer recurrent 13.40 12.74 3 26593 31 70901817
Blindness transient 13.38 12.74 12 26584 4424 70897424
Hepatic encephalopathy 13.17 12.74 27 26569 22091 70879757
Jaundice 13.11 12.74 45 26551 50063 70851785
Hyperaesthesia teeth 13.11 12.74 8 26588 1640 70900208
Intestinal obstruction 13.03 12.74 38 26558 38787 70863061
Respiratory symptom 12.96 12.74 11 26585 3770 70898078

FDA Adverse Event Reporting System (Pediatric)

None

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 antidiabetic
CHEBI has role CHEBI:68612 dipeptidyl peptidase-4 inhibitors

Drug Use | Suggest Off label Use Form| |View source of the data|

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




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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
Prolyl endopeptidase FAP Enzyme IC50 7.05 CHEMBL
Dipeptidyl peptidase 9 Enzyme IC50 4 CHEMBL
Muscarinic acetylcholine receptor M1 GPCR IC50 6.53 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 33 sections
Tradjenta HUMAN PRESCRIPTION DRUG LABEL 1 0597-0140 TABLET, FILM COATED 5 mg ORAL NDA 33 sections
Jentadueto HUMAN PRESCRIPTION DRUG LABEL 2 0597-0146 TABLET, FILM COATED 2.50 mg ORAL NDA 34 sections
Jentadueto HUMAN PRESCRIPTION DRUG LABEL 2 0597-0146 TABLET, FILM COATED 2.50 mg ORAL NDA 34 sections
Jentadueto HUMAN PRESCRIPTION DRUG LABEL 2 0597-0147 TABLET, FILM COATED 2.50 mg ORAL NDA 34 sections
Jentadueto HUMAN PRESCRIPTION DRUG LABEL 2 0597-0147 TABLET, FILM COATED 2.50 mg ORAL NDA 34 sections
Jentadueto HUMAN PRESCRIPTION DRUG LABEL 2 0597-0148 TABLET, FILM COATED 2.50 mg ORAL NDA 34 sections
Jentadueto HUMAN PRESCRIPTION DRUG LABEL 2 0597-0148 TABLET, FILM COATED 2.50 mg ORAL NDA 34 sections
Glyxambi HUMAN PRESCRIPTION DRUG LABEL 2 0597-0164 TABLET, FILM COATED 5 mg ORAL NDA 32 sections
Glyxambi HUMAN PRESCRIPTION DRUG LABEL 2 0597-0164 TABLET, FILM COATED 5 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
Glyxambi HUMAN PRESCRIPTION DRUG LABEL 2 0597-0182 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 0597-0380 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 0597-0385 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 0597-0390 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
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 31 sections
Tradjenta HUMAN PRESCRIPTION DRUG LABEL 1 55154-0410 TABLET, FILM COATED 5 mg ORAL NDA 31 sections
Tradjenta HUMAN PRESCRIPTION DRUG LABEL 1 55154-0410 TABLET, FILM COATED 5 mg ORAL NDA 31 sections
Jentadueto HUMAN PRESCRIPTION DRUG LABEL 2 63629-6524 TABLET, FILM COATED 2.50 mg ORAL NDA 31 sections