empagliflozin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
sodium glucose co-transporter inhibitors, phlorizin derivatives 4830 864070-44-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • empagliflozin
  • BI 10773
  • jardiance
Empagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
  • Molecular weight: 450.91
  • Formula: C23H27ClO7
  • CLOGP: 2.58
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 4
  • TPSA: 108.61
  • ALOGS: -3.61
  • ROTB: 6

  • Status: ONP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
17.50 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Hosey CM, Chan R, Benet LZ

Approvals:

DateAgencyCompanyOrphan
Aug. 1, 2014 FDA BOEHRINGER INGELHEIM
March 20, 2014 EMA
Dec. 26, 2014 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 4532.94 17.85 1036 13125 16836 50574127
Ketoacidosis 1844.86 17.85 379 13782 3516 50587447
Euglycaemic diabetic ketoacidosis 1831.33 17.85 357 13804 2462 50588501
Fungal infection 806.25 17.85 306 13855 29659 50561304
Blood ketone body increased 268.42 17.85 49 14112 221 50590742
Glycosylated haemoglobin increased 163.93 17.85 73 14088 10533 50580430
Blood glucose increased 157.11 17.85 142 14019 71182 50519781
Ketosis 140.58 17.85 32 14129 491 50590472
Urine ketone body present 137.78 17.85 43 14118 2290 50588673
Metabolic acidosis 124.29 17.85 96 14065 38729 50552234
Vomiting 114.35 17.85 334 13827 460424 50130539
Urinary tract infection 108.56 17.85 211 13950 223809 50367154
Necrotising fasciitis 105.17 17.85 36 14125 2568 50588395
Ketonuria 95.83 17.85 23 14138 449 50590514
Dehydration 94.65 17.85 160 14001 152289 50438674
Glomerular filtration rate decreased 81.74 17.85 47 14114 11605 50579358
Emphysematous pyelonephritis 76.41 17.85 16 14145 162 50590801
Pollakiuria 76.35 17.85 59 14102 23792 50567171
Blood glucose abnormal 75.41 17.85 37 14124 6635 50584328
Hyperglycaemia 75.23 17.85 70 14091 36335 50554628
Malignant mediastinal neoplasm 72.19 17.85 19 14142 545 50590418
Pancreatitis 64.17 17.85 69 14092 42545 50548418
Pruritus genital 60.96 17.85 17 14144 609 50590354
Vulvovaginal pruritus 58.09 17.85 23 14138 2473 50588490
Acute kidney injury 56.88 17.85 166 13995 227892 50363071
Acetonaemia 55.66 17.85 11 14150 81 50590882
Nausea 54.67 17.85 360 13801 705038 49885925
Hypoglycaemia 54.51 17.85 71 14090 53510 50537453
Diabetic ketosis 52.90 17.85 12 14149 181 50590782
Urine ketone body 51.14 17.85 11 14150 128 50590835
Lactic acidosis 50.19 17.85 54 14107 33301 50557662
Urosepsis 48.93 17.85 38 14123 15427 50575536
Blood ketone body 48.52 17.85 9 14152 45 50590918
Crush syndrome 46.28 17.85 10 14151 119 50590844
Toe amputation 46.15 17.85 18 14143 1859 50589104
Pyelonephritis 45.62 17.85 36 14125 14953 50576010
Perinephric abscess 43.47 17.85 10 14151 161 50590802
Genital infection fungal 42.91 17.85 10 14151 171 50590792
Prerenal failure 42.75 17.85 16 14145 1477 50589486
Toxicity to various agents 42.19 17.85 5 14156 212494 50378469
Vulvovaginitis 42.19 17.85 11 14150 304 50590659
Blood immunoglobulin E increased 42.17 17.85 18 14143 2341 50588622
Polyuria 40.25 17.85 25 14136 7096 50583867
Altered state of consciousness 39.33 17.85 39 14122 21871 50569092
Hyperglycaemic hyperosmolar nonketotic syndrome 39.02 17.85 12 14149 608 50590355
Sensorimotor disorder 38.45 17.85 11 14150 433 50590530
Vulvovaginal mycotic infection 36.46 17.85 20 14141 4509 50586454
Genitourinary tract infection 36.30 17.85 9 14152 202 50590761
Pyelonephritis fungal 36.30 17.85 8 14153 105 50590858
Blood pH abnormal 35.91 17.85 5 14156 0 50590963
Blood ketone body present 34.53 17.85 6 14155 19 50590944
Pain 32.72 17.85 71 14090 578832 50012131
Diabetes mellitus inadequate control 32.53 17.85 28 14133 13117 50577846
Glycosuria 32.33 17.85 12 14149 1082 50589881
Drug ineffective 32.01 17.85 120 14041 819213 49771750
Glycosylated haemoglobin abnormal 31.68 17.85 7 14154 93 50590870
Weight decreased 30.79 17.85 133 14028 221112 50369851
Candida sepsis 30.62 17.85 12 14149 1255 50589708
Diabetic ketoacidotic hyperglycaemic coma 29.60 17.85 6 14155 51 50590912
Genital infection 29.49 17.85 6 14155 52 50590911
Joint swelling 29.44 17.85 16 14145 245270 50345693
Stoma site ulcer 29.35 17.85 8 14153 263 50590700
Glycosylated haemoglobin decreased 28.94 17.85 9 14152 473 50590490
pH body fluid abnormal 27.50 17.85 6 14155 75 50590888
Systemic candida 27.20 17.85 14 14147 2776 50588187
Chest wall haematoma 27.18 17.85 7 14154 184 50590779
Infusion related reaction 27.11 17.85 7 14154 169550 50421413
Drug hypersensitivity 26.49 17.85 19 14142 250991 50339972
Rheumatoid arthritis 26.12 17.85 12 14149 202538 50388425
Coagulation test abnormal 25.95 17.85 9 14152 667 50590296
Neutropenia 25.88 17.85 5 14156 147960 50443003
Glucose urine present 25.77 17.85 9 14152 681 50590282
Diarrhoea 25.63 17.85 264 13897 588212 50002751
Creatinine renal clearance 25.49 17.85 4 14157 5 50590958
Thirst 24.97 17.85 22 14139 10628 50580335
Swelling 24.24 17.85 13 14148 200859 50390104
Candida infection 23.64 17.85 31 14130 23492 50567471
Exposure during pregnancy 23.63 17.85 3 14158 121012 50469951
Language disorder 23.50 17.85 11 14150 1777 50589186
Pemphigus 23.41 17.85 3 14158 120163 50470800
Hyperparathyroidism secondary 23.14 17.85 10 14151 1340 50589623
Hyperphosphataemia 23.02 17.85 11 14150 1860 50589103
Blood glucose normal 22.94 17.85 4 14157 13 50590950
Abdominal pain 22.82 17.85 128 14033 236100 50354863
Drug intolerance 22.58 17.85 17 14144 219087 50371876
Female reproductive tract disorder 22.53 17.85 7 14154 367 50590596
Diabetic metabolic decompensation 22.26 17.85 10 14151 1470 50589493
Necrotising soft tissue infection 22.26 17.85 5 14156 72 50590891
Glossodynia 22.24 17.85 3 14158 115566 50475397
Vulvovaginal candidiasis 21.98 17.85 12 14149 2680 50588283
Vulval abscess 21.91 17.85 8 14153 689 50590274
Abnormal loss of weight 21.82 17.85 15 14146 5049 50585914
Acidosis 21.76 17.85 20 14141 10207 50580756
Haematuria 21.59 17.85 31 14130 25582 50565381
Fungal cystitis 21.55 17.85 3 14158 0 50590963
Limb amputation 21.25 17.85 4 14157 22 50590941
Papilloma 21.12 17.85 6 14155 230 50590733
Therapeutic product effect decreased 21.02 17.85 6 14155 136044 50454919
Haematochezia 20.98 17.85 39 14122 39843 50551120
Genital candidiasis 20.57 17.85 5 14156 103 50590860
Hypophagia 19.72 17.85 31 14130 27697 50563266
Emphysematous cystitis 19.50 17.85 5 14156 129 50590834
Blood bicarbonate abnormal 19.43 17.85 4 14157 37 50590926
Leg amputation 19.33 17.85 10 14151 2003 50588960
Inflammatory bowel disease 19.21 17.85 12 14149 3438 50587525
Death 19.08 17.85 39 14122 325340 50265623
Pancreatitis acute 18.88 17.85 28 14133 23784 50567179
Microalbuminuria 18.88 17.85 6 14155 339 50590624
Dizziness 18.81 17.85 163 13998 346206 50244757
Periorbital haematoma 17.97 17.85 7 14154 720 50590243
Bronchiectasis 17.89 17.85 18 14143 10265 50580698
COVID-19 17.86 17.85 40 14121 46622 50544341
Sinusitis 17.86 17.85 13 14148 170545 50420418

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
Diabetic ketoacidosis 4266.73 15.77 1152 18805 14921 29539649
Euglycaemic diabetic ketoacidosis 1953.71 15.77 433 19524 2197 29552373
Ketoacidosis 1643.68 15.77 400 19557 3239 29551331
Pollakiuria 282.38 15.77 163 19794 16753 29537817
Fungal infection 242.14 15.77 137 19820 13548 29541022
Ketonuria 222.42 15.77 56 19901 524 29554046
Urine ketone body present 193.99 15.77 57 19900 991 29553579
Urinary tract infection 188.73 15.77 238 19719 72116 29482454
Metabolic acidosis 186.70 15.77 174 19783 37488 29517082
Blood ketone body increased 182.46 15.77 44 19913 338 29554232
Balanoposthitis 178.91 15.77 53 19904 949 29553621
Ketosis 178.00 15.77 44 19913 379 29554191
Glycosylated haemoglobin increased 160.34 15.77 92 19865 9334 29545236
Toe amputation 157.32 15.77 58 19899 2097 29552473
Hyperglycaemia 123.05 15.77 133 19824 34154 29520416
Polyuria 114.99 15.77 68 19889 7294 29547276
Blood glucose abnormal 112.36 15.77 59 19898 5024 29549546
Blood glucose increased 109.83 15.77 165 19792 58819 29495751
Urine ketone body 104.78 15.77 20 19937 38 29554532
Dehydration 99.51 15.77 231 19726 114517 29440053
Necrotising fasciitis 91.71 15.77 45 19912 3320 29551250
Lactic acidosis 85.93 15.77 104 19853 30143 29524427
Acidosis 83.99 15.77 62 19895 9643 29544927
Thirst 81.09 15.77 52 19905 6439 29548131
Blood ketone body 80.02 15.77 17 19940 67 29554503
Pancreatitis 76.58 15.77 105 19852 34409 29520161
Gangrene 73.93 15.77 42 19915 4176 29550394
Phimosis 71.20 15.77 24 19933 663 29553907
Vomiting 70.19 15.77 306 19651 211954 29342616
Weight decreased 68.07 15.77 240 19717 150665 29403905
Urosepsis 67.84 15.77 57 19900 10689 29543881
Acute kidney injury 67.17 15.77 354 19603 264913 29289657
Death 66.64 15.77 80 19877 342004 29212566
Dysuria 65.10 15.77 78 19879 22362 29532208
Genital infection fungal 62.58 15.77 16 19941 160 29554410
Diabetes mellitus inadequate control 59.92 15.77 56 19901 12078 29542492
Neutropenia 59.43 15.77 9 19948 131702 29422868
Genital rash 58.97 15.77 19 19938 454 29554116
Glomerular filtration rate abnormal 57.92 15.77 21 19936 723 29553847
Hypovolaemia 55.64 15.77 45 19912 8000 29546570
pH body fluid abnormal 55.61 15.77 10 19947 11 29554559
Thrombocytopenia 54.83 15.77 12 19945 134811 29419759
Toxicity to various agents 53.78 15.77 25 19932 173636 29380934
Febrile neutropenia 52.19 15.77 7 19950 112233 29442337
Diabetic ketosis 50.36 15.77 12 19945 87 29554483
Haematocrit increased 50.03 15.77 24 19933 1684 29552886
Perineal abscess 49.81 15.77 14 19943 206 29554364
Product monitoring error 48.15 15.77 27 19930 2618 29551952
Balanitis candida 47.49 15.77 12 19945 114 29554456
Insulin C-peptide decreased 46.76 15.77 10 19947 41 29554529
Blood ketone body present 46.56 15.77 10 19947 42 29554528
Scrotal abscess 45.96 15.77 16 19941 488 29554082
Glycosuria 45.57 15.77 20 19937 1142 29553428
Dizziness 45.06 15.77 249 19708 189435 29365135
Drug ineffective 44.26 15.77 114 19843 363056 29191514
Cellulitis of male external genital organ 44.04 15.77 10 19947 57 29554513
Glomerular filtration rate decreased 42.66 15.77 45 19912 11221 29543349
Drug interaction 41.78 15.77 43 19914 197342 29357228
Hypoglycaemia 41.43 15.77 97 19860 48249 29506321
Acetonaemia 40.90 15.77 11 19946 136 29554434
Haemoglobin increased 40.77 15.77 25 19932 2861 29551709
Leg amputation 40.12 15.77 22 19935 2042 29552528
Diabetic foot 38.66 15.77 22 19935 2194 29552376
Prostatitis 38.38 15.77 29 19928 4668 29549902
Cerebral infarction 36.21 15.77 62 19895 24613 29529957
Glycosylated haemoglobin 35.38 15.77 6 19951 3 29554567
Penile discomfort 35.38 15.77 6 19951 3 29554567
Mucosal dryness 34.90 15.77 16 19941 1013 29553557
White blood cell count decreased 34.73 15.77 7 19950 83355 29471215
Pancytopenia 34.61 15.77 7 19950 83161 29471409
Seizure 34.53 15.77 10 19947 93113 29461457
Pruritus genital 33.84 15.77 13 19944 527 29554043
Micturition urgency 33.80 15.77 28 19929 5145 29549425
Glycosylated haemoglobin abnormal 33.63 15.77 9 19948 109 29554461
Genital infection male 33.18 15.77 6 19951 7 29554563
Diabetic metabolic decompensation 32.90 15.77 17 19940 1399 29553171
Acquired phimosis 32.35 15.77 8 19949 69 29554501
Anaemia 31.13 15.77 55 19902 200896 29353674
Genital discomfort 30.52 15.77 7 19950 42 29554528
Kussmaul respiration 30.35 15.77 8 19949 91 29554479
Left atrial dilatation 30.05 15.77 17 19940 1676 29552894
Skin ulcer 29.86 15.77 49 19908 18791 29535779
Circumcision 29.76 15.77 6 19951 17 29554553
Spondylolysis 29.59 15.77 7 19950 49 29554521
Completed suicide 29.47 15.77 12 19945 90234 29464336
Skin pressure mark 28.45 15.77 7 19950 59 29554511
Disease progression 28.23 15.77 10 19947 81906 29472664
Platelet count decreased 28.09 15.77 18 19939 104654 29449916
Altered state of consciousness 27.91 15.77 49 19908 19840 29534730
COVID-19 27.36 15.77 69 19888 35945 29518625
Haemoglobin decreased 27.27 15.77 20 19937 108355 29446215
Foot amputation 27.17 15.77 11 19946 513 29554057
Drug abuse 27.11 15.77 10 19947 79873 29474697
Lumbosacral radiculoplexus neuropathy 26.60 15.77 6 19951 33 29554537
Penile rash 25.40 15.77 5 19952 12 29554558
Perineal cellulitis 25.21 15.77 4 19953 0 29554570
Leukopenia 24.35 15.77 4 19953 55199 29499371
Haematuria 24.10 15.77 75 19882 44064 29510506
Necrotising soft tissue infection 23.84 15.77 6 19951 56 29554514
Penile discharge 23.74 15.77 6 19951 57 29554513
Renal impairment 23.57 15.77 113 19844 81220 29473350
Glucose urine present 23.53 15.77 12 19945 961 29553609
Genital candidiasis 23.20 15.77 6 19951 63 29554507
Pancreatitis acute 23.18 15.77 51 19906 24334 29530236
Polydipsia 23.15 15.77 19 19938 3446 29551124
Anion gap increased 23.12 15.77 14 19943 1566 29553004
Decreased ventricular preload 23.09 15.77 5 19952 22 29554548
Pleural effusion 22.77 15.77 10 19947 71898 29482672
Nausea 22.70 15.77 296 19661 288959 29265611
Pancreatic carcinoma 22.63 15.77 26 19931 7124 29547446
Diabetic ketoacidotic hyperglycaemic coma 22.49 15.77 7 19950 149 29554421
Neutrophilia 22.22 15.77 19 19938 3647 29550923
Creatinine renal clearance increased 22.18 15.77 9 19948 422 29554148
Cardio-respiratory arrest 21.59 15.77 4 19953 50597 29503973
Diabetic nephropathy 20.79 15.77 14 19943 1881 29552689
Alanine aminotransferase increased 20.73 15.77 11 19946 70933 29483637
Non-compaction cardiomyopathy 20.66 15.77 5 19952 39 29554531
N-terminal prohormone brain natriuretic peptide increased 20.54 15.77 14 19943 1918 29552652
Hyperthyroidism 20.31 15.77 27 19930 8581 29545989
Gastroenteritis 20.24 15.77 33 19924 12583 29541987
Pneumonia 20.20 15.77 130 19827 320042 29234528
International normalised ratio increased 20.06 15.77 3 19954 44369 29510201
Amputation 19.73 15.77 9 19948 563 29554007
Application site haematoma 19.65 15.77 5 19952 49 29554521
Tachypnoea 19.62 15.77 36 19921 15079 29539491
Skin disorder 19.47 15.77 31 19926 11587 29542983
Pterygium 19.13 15.77 6 19951 131 29554439
Genital infection 18.99 15.77 4 19953 15 29554555
Scrotal gangrene 18.91 15.77 3 19954 0 29554570
Genital discolouration 18.91 15.77 3 19954 0 29554570
Scrotal cellulitis 18.91 15.77 3 19954 0 29554570
Genital infection bacterial 18.91 15.77 3 19954 0 29554570
Perineal necrosis 18.91 15.77 3 19954 0 29554570
Hyperlactacidaemia 18.56 15.77 15 19942 2663 29551907
Pancreatitis necrotising 18.10 15.77 14 19943 2333 29552237
Urine odour abnormal 18.02 15.77 10 19947 950 29553620
Aspartate aminotransferase increased 17.84 15.77 9 19948 59716 29494854
Groin infection 17.39 15.77 6 19951 178 29554392
Electrocardiogram abnormal 17.32 15.77 23 19934 7299 29547271
Genital pain 17.14 15.77 6 19951 186 29554384
Diabetic coma 17.08 15.77 9 19948 771 29553799
Urine output increased 17.04 15.77 10 19947 1056 29553514
Orchitis 16.98 15.77 11 19946 1385 29553185
Bladder cancer 16.94 15.77 27 19930 10100 29544470
Rhabdomyolysis 16.94 15.77 10 19947 60798 29493772
Blood pH abnormal 16.83 15.77 3 19954 3 29554567
Blood glucose fluctuation 16.61 15.77 16 19941 3581 29550989
Anxiety 16.48 15.77 20 19937 85345 29469225
Malaise 15.86 15.77 171 19786 159431 29395139

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
Diabetic ketoacidosis 6492.33 14.08 1678 27227 28167 64441660
Euglycaemic diabetic ketoacidosis 3505.48 14.08 740 28165 4670 64465157
Ketoacidosis 2765.01 14.08 636 28269 6227 64463600
Blood ketone body increased 343.80 14.08 75 28830 557 64469270
Metabolic acidosis 314.81 14.08 258 28647 70700 64399127
Pollakiuria 297.76 14.08 182 28723 31348 64438479
Fungal infection 288.87 14.08 184 28721 34067 64435760
Urine ketone body present 268.92 14.08 87 28818 3220 64466607
Ketonuria 266.56 14.08 68 28837 1049 64468778
Ketosis 252.11 14.08 63 28842 890 64468937
Hyperglycaemia 204.31 14.08 189 28716 60779 64409048
Glycosylated haemoglobin increased 203.07 14.08 112 28793 15907 64453920
Urinary tract infection 191.43 14.08 359 28546 231237 64238590
Dehydration 180.34 14.08 337 28568 216426 64253401
Blood glucose increased 178.81 14.08 220 28685 97853 64371974
Toe amputation 175.00 14.08 64 28841 3436 64466391
Blood glucose abnormal 163.87 14.08 80 28825 8833 64460994
Vomiting 152.98 14.08 567 28338 550550 63919277
Polyuria 145.57 14.08 83 28822 12560 64457267
Acute kidney injury 144.16 14.08 485 28420 448755 64021072
Balanoposthitis 144.08 14.08 39 28866 765 64469062
Lactic acidosis 137.27 14.08 153 28752 61257 64408570
Necrotising fasciitis 132.69 14.08 59 28846 5267 64464560
Blood ketone body 113.03 14.08 23 28882 116 64469711
Urosepsis 103.47 14.08 83 28822 22011 64447816
Urine ketone body 100.06 14.08 22 28883 170 64469657
Pancreatitis 96.33 14.08 126 28779 59481 64410346
Thirst 92.73 14.08 65 28840 14072 64455755
Diabetic ketosis 91.06 14.08 23 28882 340 64469487
Acidosis 90.10 14.08 70 28835 17725 64452102
Toxicity to various agents 85.92 14.08 28 28877 363485 64106342
Diabetes mellitus inadequate control 85.06 14.08 73 28832 21248 64448579
Glomerular filtration rate decreased 84.23 14.08 70 28835 19502 64450325
Hypoglycaemia 83.77 14.08 147 28758 89745 64380082
Acetonaemia 82.06 14.08 20 28885 253 64469574
Glycosuria 78.67 14.08 31 28874 2043 64467784
Emphysematous pyelonephritis 74.35 14.08 18 28887 221 64469606
Phimosis 73 14.08 20 28885 411 64469416
Weight decreased 72.30 14.08 286 28619 285453 64184374
Glomerular filtration rate abnormal 70.35 14.08 25 28880 1234 64468593
Neutropenia 69.25 14.08 12 28893 239612 64230215
Drug ineffective 68.17 14.08 175 28730 840072 63629755
Dysuria 68.08 14.08 89 28816 41968 64427859
Pruritus genital 67.32 14.08 23 28882 1009 64468818
Completed suicide 63.20 14.08 12 28893 224402 64245425
Haematocrit increased 61.40 14.08 30 28875 3315 64466512
Malignant mediastinal neoplasm 60.01 14.08 18 28887 516 64469311
Blood ketone body present 59.92 14.08 12 28893 55 64469772
Altered state of consciousness 59.48 14.08 79 28826 37823 64432004
Genital infection fungal 58.83 14.08 14 28891 159 64469668
Hypovolaemia 57.69 14.08 51 28854 15435 64454392
Scrotal abscess 55.24 14.08 16 28889 405 64469422
Cerebral infarction 54.60 14.08 79 28826 40965 64428862
Gangrene 53.46 14.08 36 28869 7302 64462525
Balanitis candida 52.46 14.08 12 28893 113 64469714
Pain 51.43 14.08 107 28798 553404 63916423
Genital rash 51.40 14.08 18 28887 851 64468976
Nausea 50.81 14.08 556 28349 785244 63684583
Diabetic ketoacidotic hyperglycaemic coma 50.27 14.08 13 28892 212 64469615
Death 49.46 14.08 88 28817 482617 63987210
Diabetic foot 49.39 14.08 25 28880 2980 64466847
Perineal abscess 49.20 14.08 15 28890 455 64469372
Blood pH abnormal 47.66 14.08 8 28897 9 64469818
Febrile neutropenia 46.91 14.08 13 28892 187644 64282183
Insulin C-peptide decreased 46.86 14.08 10 28895 66 64469761
Thrombocytopenia 46.57 14.08 21 28884 223780 64246047
Haematuria 46.40 14.08 91 28814 60380 64409447
Necrotising soft tissue infection 46.39 14.08 12 28893 196 64469631
Cellulitis of male external genital organ 46.34 14.08 9 28896 34 64469793
White blood cell count decreased 45.37 14.08 8 28897 157829 64311998
Polydipsia 43.47 14.08 29 28876 5792 64464035
Pancreatitis acute 42.40 14.08 72 28833 42783 64427044
Pancytopenia 41.77 14.08 7 28898 143302 64326525
Perinephric abscess 40.96 14.08 11 28894 209 64469618
Leg amputation 40.79 14.08 23 28882 3404 64466423
Product monitoring error 40.31 14.08 27 28878 5427 64464400
Pyelonephritis 40.24 14.08 44 28861 17222 64452605
Renal impairment 39.76 14.08 142 28763 134875 64334952
Genital candidiasis 39.61 14.08 9 28896 82 64469745
Drug hypersensitivity 38.65 14.08 30 28875 237785 64232042
Vulvovaginitis 38.18 14.08 11 28894 273 64469554
Rheumatoid arthritis 38.15 14.08 13 28892 164281 64305546
Penile discomfort 37.83 14.08 6 28899 3 64469824
Anion gap increased 37.78 14.08 21 28884 3023 64466804
Crush syndrome 37.75 14.08 10 28895 180 64469647
Genital infection 37.59 14.08 8 28897 52 64469775
Dizziness 37.30 14.08 324 28581 429839 64039988
Prostatitis 37.07 14.08 22 28883 3584 64466243
Drug interaction 37.06 14.08 66 28839 362017 64107810
Disease progression 36.96 14.08 9 28896 141671 64328156
Haemoglobin increased 36.66 14.08 25 28880 5176 64464651
Infusion related reaction 36.51 14.08 14 28891 164453 64305374
Hyperglycaemic hyperosmolar nonketotic syndrome 36.38 14.08 17 28888 1702 64468125
COVID-19 36.17 14.08 86 28819 65054 64404773
Stomatitis 35.12 14.08 4 28901 109601 64360226
Genitourinary tract infection 34.49 14.08 10 28895 254 64469573
Leukopenia 34.25 14.08 3 28902 101239 64368588
Glucose urine present 34.10 14.08 16 28889 1616 64468211
Drug abuse 33.40 14.08 9 28896 132365 64337462
Synovitis 33.35 14.08 3 28902 99087 64370740
Product prescribing error 33.24 14.08 58 28847 35211 64434616
Acquired phimosis 33.23 14.08 7 28898 43 64469784
Therapeutic product effect decreased 32.81 14.08 6 28899 115345 64354482
Drug intolerance 32.78 14.08 22 28883 187970 64281857
Joint swelling 32.73 14.08 29 28876 215353 64254474
Pancreatic carcinoma 32.48 14.08 31 28874 10342 64459485
Pyelonephritis fungal 32.21 14.08 8 28897 110 64469717
Language disorder 31.71 14.08 18 28887 2699 64467128
pH body fluid abnormal 31.69 14.08 8 28897 118 64469709
Genital infection male 31.21 14.08 5 28900 3 64469824
Anxiety 31.14 14.08 27 28878 202622 64267205
Arthropathy 30.94 14.08 8 28897 120959 64348868
Tachypnoea 30.84 14.08 48 28857 26523 64443304
Glycosylated haemoglobin abnormal 30.57 14.08 8 28897 137 64469690
Cardio-respiratory arrest 30.52 14.08 4 28901 98389 64371438
Kussmaul respiration 30.47 14.08 10 28895 387 64469440
Sinusitis 29.86 14.08 14 28891 145914 64323913
Skin pressure mark 29.45 14.08 7 28898 79 64469748
Vulvovaginal pruritus 28.99 14.08 15 28890 1871 64467956
Diabetic metabolic decompensation 28.98 14.08 17 28888 2711 64467116
Penile discharge 28.90 14.08 6 28899 34 64469793
Haemoglobin decreased 28.76 14.08 27 28878 195036 64274791
Glucose urine 28.75 14.08 6 28899 35 64469792
Foot amputation 28.43 14.08 11 28894 690 64469137
Spondylolysis 27.93 14.08 7 28898 100 64469727
Treatment failure 27.54 14.08 9 28896 116807 64353020
Mucosal dryness 27.48 14.08 17 28888 2984 64466843
Penile rash 27.44 14.08 5 28900 12 64469815
Platelet count decreased 27.43 14.08 21 28884 167690 64302137
Sensorimotor disorder 27.11 14.08 11 28894 782 64469045
Systemic candida 27.05 14.08 21 28884 5308 64464519
Micturition urgency 26.97 14.08 28 28877 10331 64459496
Fungal cystitis 26.84 14.08 4 28901 0 64469827
Diabetic nephropathy 26.78 14.08 16 28889 2638 64467189
Insomnia 26.21 14.08 30 28875 197806 64272021
Left atrial dilatation 26.17 14.08 16 28889 2750 64467077
Stoma site ulcer 26.01 14.08 8 28897 250 64469577
Blood immunoglobulin E increased 25.96 14.08 18 28887 3826 64466001
Seizure 25.92 14.08 22 28883 166870 64302957
Blood glucose normal 25.52 14.08 5 28900 20 64469807
Lumbosacral radiculoplexus neuropathy 25.30 14.08 6 28899 67 64469760
Blood glucose fluctuation 25.00 14.08 21 28884 5934 64463893
Hypophagia 25.00 14.08 55 28850 39532 64430295
Overdose 24.82 14.08 21 28884 159545 64310282
Contraindicated product administered 24.22 14.08 9 28896 107820 64362007
Prerenal failure 23.93 14.08 16 28889 3206 64466621
Bladder cancer 23.91 14.08 27 28878 10947 64458880
Candida infection 23.75 14.08 47 28858 31372 64438455
Urine output increased 23.54 14.08 13 28892 1848 64467979
Sepsis 23.41 14.08 180 28725 230161 64239666
Decreased ventricular preload 23.30 14.08 5 28900 34 64469793
Electrocardiogram QT prolonged 22.88 14.08 4 28901 79444 64390383
Cardiac failure chronic 22.75 14.08 24 28881 9017 64460810
Hyperthyroidism 22.74 14.08 34 28871 18145 64451682
Hypersensitivity 22.71 14.08 33 28872 196419 64273408
Non-compaction cardiomyopathy 22.70 14.08 5 28900 39 64469788
Emphysematous cystitis 22.69 14.08 7 28898 221 64469606
N-terminal prohormone brain natriuretic peptide increased 22.49 14.08 16 28889 3543 64466284
Intentional product misuse 22.28 14.08 3 28902 72292 64397535
Urinary tract candidiasis 22.02 14.08 9 28896 652 64469175
Perineal necrosis 21.73 14.08 6 28899 127 64469700
Hypertension 21.66 14.08 53 28852 259208 64210619
Nasopharyngitis 21.64 14.08 34 28871 196039 64273788
Blood bicarbonate abnormal 21.47 14.08 6 28899 133 64469694
Candida sepsis 21.37 14.08 13 28892 2215 64467612
Diabetic foot infection 21.26 14.08 9 28896 713 64469114
Neutrophilia 20.95 14.08 20 28885 6674 64463153
Aspartate aminotransferase increased 20.89 14.08 14 28891 119774 64350053
Anal abscess 20.83 14.08 21 28884 7487 64462340
Gastroenteritis 20.74 14.08 43 28862 29668 64440159
International normalised ratio increased 20.70 14.08 5 28900 79162 64390665
Swelling 20.46 14.08 25 28880 160193 64309634
Malaise 20.44 14.08 269 28636 395978 64073849
Fatigue 20.43 14.08 226 28679 748504 63721323
Diabetic coma 20.33 14.08 10 28895 1121 64468706
Acute myocardial infarction 20.22 14.08 73 28832 69645 64400182
Scrotal cellulitis 20.13 14.08 3 28902 0 64469827
Genital discolouration 20.13 14.08 3 28902 0 64469827
Perineal rash 20.13 14.08 3 28902 0 64469827
Scrotal gangrene 20.13 14.08 3 28902 0 64469827
Polycythaemia 20.10 14.08 12 28893 1975 64467852
Blood insulin decreased 20.03 14.08 4 28901 18 64469809
Abdominal pain 20.01 14.08 221 28684 312154 64157673
Neutrophil count decreased 19.94 14.08 5 28900 77191 64392636
Application site haematoma 19.85 14.08 5 28900 73 64469754
Amputation 19.78 14.08 8 28897 564 64469263
Perineal cellulitis 19.69 14.08 4 28901 20 64469807
Creatinine renal clearance 19.52 14.08 4 28901 21 64469806
Lower respiratory tract infection 19.47 14.08 9 28896 94605 64375222
Pleural effusion 19.26 14.08 17 28888 126542 64343285
Glycosylated haemoglobin decreased 19.21 14.08 8 28897 608 64469219
Chest wall haematoma 19.13 14.08 7 28898 376 64469451
Haematochezia 18.83 14.08 69 28836 66304 64403523
Angina pectoris 18.34 14.08 53 28852 45028 64424799
Orchidectomy 18.30 14.08 4 28901 30 64469797
Vesicoureteric reflux 18.19 14.08 5 28900 104 64469723
Skin ulcer 18.18 14.08 52 28853 43922 64425905
Genital discomfort 18.10 14.08 5 28900 106 64469721
Contusion 17.72 14.08 15 28890 113950 64355877
Pemphigus 17.60 14.08 3 28902 60698 64409129
Coagulation test abnormal 17.49 14.08 9 28896 1110 64468717
Abnormal loss of weight 17.49 14.08 19 28886 7381 64462446
Leukocyturia 17.44 14.08 10 28895 1528 64468299
Anaemia 17.44 14.08 99 28806 378581 64091246
Alanine aminotransferase increased 17.43 14.08 22 28883 139009 64330818
Orchitis 17.42 14.08 9 28896 1119 64468708
Vulvovaginal candidiasis 16.85 14.08 11 28894 2119 64467708
Sacroiliac joint dysfunction 16.76 14.08 4 28901 46 64469781
Penile erythema 16.65 14.08 5 28900 144 64469683
Testicular abscess 16.53 14.08 4 28901 49 64469778
Headache 16.40 14.08 155 28750 529312 63940515
Hyperlactacidaemia 16.17 14.08 15 28890 4829 64464998
Product use issue 16.08 14.08 27 28878 151688 64318139
Vulval abscess 15.84 14.08 7 28898 615 64469212
Arthralgia 15.67 14.08 125 28780 442135 64027692
Vulvovaginal mycotic infection 15.65 14.08 13 28892 3615 64466212
Hypernatraemia 15.53 14.08 23 28882 12166 64457661
Gait disturbance 15.32 14.08 34 28871 172121 64297706
Left atrial enlargement 15.27 14.08 8 28897 1024 64468803
Hyperventilation 15.19 14.08 17 28888 6823 64463004
Electrocardiogram abnormal 15.15 14.08 24 28881 13457 64456370
Paraesthesia 15.15 14.08 23 28882 134499 64335328
Presyncope 15.00 14.08 42 28863 35047 64434780
Leukocytosis 14.99 14.08 44 28861 37696 64432131
Depression 14.88 14.08 38 28867 183253 64286574
Postprandial hypoglycaemia 14.65 14.08 4 28901 81 64469746
Genital erythema 14.62 14.08 5 28900 220 64469607
Hyperkalaemia 14.44 14.08 86 28819 101043 64368784
Pemphigoid 14.43 14.08 23 28882 12963 64456864
Pericarditis 14.41 14.08 5 28900 62511 64407316
Diabetic neuropathy 14.33 14.08 15 28890 5586 64464241
Glycosylated haemoglobin 14.30 14.08 3 28902 18 64469809

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A10BD19 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD20 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 A10BK03 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
MeSH PA D007004 Hypoglycemic Agents
MeSH PA D000077203 Sodium-Glucose Transporter 2 Inhibitors
FDA MoA N0000187058 Sodium-Glucose Transporter 2 Inhibitors
FDA EPC N0000187059 Sodium-Glucose Cotransporter 2 Inhibitor
CHEBI has role CHEBI:35526 antidiabetic
CHEBI has role CHEBI:73273 sodium-glucose transport protein subtype 2 inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Diabetes mellitus type 2 indication 44054006 DOID:9352
Chronic heart failure indication 48447003
Cardiovascular event reduce risk 405617006




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.62 acidic
pKa2 13.26 acidic
pKa3 13.7 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
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)
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
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
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
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL 8551957 Oct. 14, 2029 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
25MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL 8551957 Oct. 14, 2029 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 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
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
10MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TREATMENT-NAÏVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN
10MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 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
12.5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TREATMENT-NAÏVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN
12.5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 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
25MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TREATMENT-NAÏVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN
25MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 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
5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TREATMENT-NAÏVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN
5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 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
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
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 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 JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 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 JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 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 JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 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 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
12.5MG;1GM SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 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
12.5MG;1GM SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2
12.5MG;500MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 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
12.5MG;500MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2
5MG;1GM SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 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
5MG;1GM SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2
5MG;500MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 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
5MG;500MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2
10MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 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
10MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2
12.5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 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
12.5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2
25MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 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
25MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2
5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 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
5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2
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 JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL 9949997 May 17, 2034 METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND HEART FAILURE BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL 9949997 May 17, 2034 METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH PLUS HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS, HEART FAILURE AND REDUCED EJECTION FRACTION BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL 9949997 May 17, 2034 METHOD OF REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
25MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL 9949997 May 17, 2034 METHOD OF REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 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 JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 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 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;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 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
12.5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 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
25MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 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
5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 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
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
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
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
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL Aug. 18, 2024 REDUCE THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH HEART FAILURE AND REDUCED EJECTION FRACTION
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL Feb. 24, 2025 LABELING REVISIONS RELATED TO CLINICAL STUDIES

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium/glucose cotransporter 2 Transporter INHIBITOR Kd 7.24 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
Sodium/glucose cotransporter 4 Transporter IC50 4.96 SCIENTIFIC LITERATURE
Sodium/glucose cotransporter 5 Transporter IC50 5.96 SCIENTIFIC LITERATURE
Sodium/glucose cotransporter 1 Transporter IC50 5.08 SCIENTIFIC LITERATURE
Sodium/myo-inositol cotransporter 2 Transporter IC50 5.70 SCIENTIFIC LITERATURE

External reference:

IDSource
HDC1R2M35U UNII
D10459 KEGG_DRUG
4033569 VUID
N0000190927 NUI
4033569 VANDF
C3490348 UMLSCUI
CHEBI:82720 CHEBI
7R3 PDB_CHEM_ID
CHEMBL2107830 ChEMBL_ID
11949646 PUBCHEM_CID
DB09038 DRUGBANK_ID
9398 INN_ID
C570240 MESH_SUPPLEMENTAL_RECORD_UI
4754 IUPHAR_LIGAND_ID
1545653 RXNORM
227183 MMSL
30461 MMSL
d08275 MMSL
015572 NDDF
703894008 SNOMEDCT_US
703895009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 0597-0152 TABLET, FILM COATED 10 mg ORAL NDA 30 sections
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 0597-0152 TABLET, FILM COATED 10 mg ORAL NDA 30 sections
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 0597-0153 TABLET, FILM COATED 25 mg ORAL NDA 30 sections
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 0597-0153 TABLET, FILM COATED 25 mg ORAL NDA 30 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0159 TABLET 5 mg ORAL NDA 34 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0159 TABLET 5 mg ORAL NDA 34 sections
Glyxambi HUMAN PRESCRIPTION DRUG LABEL 2 0597-0164 TABLET, FILM COATED 25 mg ORAL NDA 32 sections
Glyxambi HUMAN PRESCRIPTION DRUG LABEL 2 0597-0164 TABLET, FILM COATED 25 mg ORAL NDA 32 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0168 TABLET 12.50 mg ORAL NDA 34 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0168 TABLET 12.50 mg ORAL NDA 34 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0175 TABLET 5 mg ORAL NDA 34 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0175 TABLET 5 mg ORAL NDA 34 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0180 TABLET 12.50 mg ORAL NDA 34 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0180 TABLET 12.50 mg ORAL NDA 34 sections
Glyxambi HUMAN PRESCRIPTION DRUG LABEL 2 0597-0182 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
Glyxambi HUMAN PRESCRIPTION DRUG LABEL 2 0597-0182 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
Synjardy XR HUMAN PRESCRIPTION DRUG LABEL 2 0597-0280 TABLET, EXTENDED RELEASE 10 mg ORAL NDA 34 sections
Synjardy XR HUMAN PRESCRIPTION DRUG LABEL 2 0597-0280 TABLET, EXTENDED RELEASE 10 mg ORAL NDA 34 sections
Synjardy XR HUMAN PRESCRIPTION DRUG LABEL 2 0597-0290 TABLET, EXTENDED RELEASE 5 mg ORAL NDA 34 sections
Synjardy XR HUMAN PRESCRIPTION DRUG LABEL 2 0597-0290 TABLET, EXTENDED RELEASE 5 mg ORAL NDA 34 sections
Synjardy XR HUMAN PRESCRIPTION DRUG LABEL 2 0597-0295 TABLET, EXTENDED RELEASE 25 mg ORAL NDA 34 sections
Synjardy XR HUMAN PRESCRIPTION DRUG LABEL 2 0597-0295 TABLET, EXTENDED RELEASE 25 mg ORAL NDA 34 sections
Synjardy XR HUMAN PRESCRIPTION DRUG LABEL 2 0597-0300 TABLET, EXTENDED RELEASE 12.50 mg ORAL NDA 34 sections
Synjardy XR HUMAN PRESCRIPTION DRUG LABEL 2 0597-0300 TABLET, EXTENDED RELEASE 12.50 mg ORAL NDA 34 sections
Trijardy XR HUMAN PRESCRIPTION DRUG LABEL 3 0597-0380 TABLET, EXTENDED RELEASE 10 mg ORAL NDA 34 sections
Trijardy XR HUMAN PRESCRIPTION DRUG LABEL 3 0597-0385 TABLET, EXTENDED RELEASE 12.50 mg ORAL NDA 34 sections
Trijardy XR HUMAN PRESCRIPTION DRUG LABEL 3 0597-0390 TABLET, EXTENDED RELEASE 25 mg ORAL NDA 34 sections
Trijardy XR HUMAN PRESCRIPTION DRUG LABEL 3 0597-0395 TABLET, EXTENDED RELEASE 5 mg ORAL NDA 34 sections
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 50090-4384 TABLET, FILM COATED 25 mg ORAL NDA 30 sections
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 50090-4384 TABLET, FILM COATED 25 mg ORAL NDA 30 sections