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

Stem definition	Drug id	CAS RN
dipeptidyl aminopeptidase-IV inhibitors	4175	668270-12-0

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
5	mg	O

ADMET properties:

Property	Value	Reference
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
S (Water solubility)	0.90 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Bocci G, Oprea TI, Benet LZ

Approvals:

Date	Agency	Company	Orphan
May 2, 2011	FDA	BOEHRINGER INGELHEIM
July 1, 2011	PMDA	Nippon Boehringer Ingelheim Co., Ltd

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Subarachnoid haemorrhage	234.59	15.61	102	17325	14181	63457414
Blood glucose increased	224.53	15.61	185	17242	83571	63388024
Pemphigoid	216.67	15.61	80	17347	7264	63464331
Cardiospasm	196.97	15.61	54	17373	1853	63469742
Hypoglycaemia	196.00	15.61	149	17278	59916	63411679
Palmoplantar keratoderma	194.23	15.61	54	17373	1953	63469642
Pruritus genital	192.33	15.61	57	17370	2597	63468998
Sleep terror	178.80	15.61	54	17373	2626	63468969
Atrial tachycardia	158.31	15.61	55	17372	4185	63467410
Carotid artery occlusion	152.84	15.61	55	17372	4639	63466956
Tension headache	147.49	15.61	55	17372	5131	63466464
Pancreatitis	141.13	15.61	113	17314	48942	63422653
Dermatitis bullous	137.20	15.61	60	17367	8448	63463147
Anosmia	132.56	15.61	55	17372	6805	63464790
Immunisation	124.21	15.61	34	17393	1159	63470436
Ventricular tachycardia	106.28	15.61	67	17360	19912	63451683
Pain of skin	104.81	15.61	55	17372	11579	63460016
Vasculitis	104.29	15.61	64	17363	18145	63453450
Facial pain	103.99	15.61	53	17374	10508	63461087
Lip swelling	98.91	15.61	76	17351	30987	63440608
Eye pruritus	97.78	15.61	62	17365	18609	63452986
Angioedema	90.60	15.61	87	17340	47878	63423717
Glycosylated haemoglobin increased	90.53	15.61	51	17376	12347	63459248
Blindness	89.30	15.61	62	17365	21637	63449958
Acute kidney injury	86.76	15.61	210	17217	263205	63208390
Renal impairment	79.27	15.61	109	17318	88246	63383349
Drug ineffective	78.26	15.61	104	17323	1044661	62426934
Muscle twitching	78.14	15.61	55	17372	19613	63451982
Intentional product misuse	73.35	15.61	87	17340	60830	63410765
Hyperglycaemia	71.72	15.61	72	17355	41795	63429800
Euglycaemic diabetic ketoacidosis	69.44	15.61	29	17398	3645	63467950
Hallucination	68.84	15.61	80	17347	54737	63416858
Diplopia	66.80	15.61	54	17373	23674	63447921
Transient ischaemic attack	66.65	15.61	66	17361	37687	63433908
Hyperlactacidaemia	62.42	15.61	25	17402	2824	63468771
Diabetic ketoacidosis	60.56	15.61	48	17379	20457	63451138
Tinnitus	60.52	15.61	61	17366	35567	63436028
Cystostomy	56.61	15.61	11	17416	75	63471520
Dry skin	55.29	15.61	73	17354	56814	63414781
Metabolic acidosis	52.00	15.61	63	17364	45006	63426589
Pancreatic carcinoma	51.98	15.61	30	17397	7598	63463997
Palpitations	51.93	15.61	103	17324	112667	63358928
Diabetes mellitus inadequate control	50.32	15.61	38	17389	15088	63456507
Hyperkalaemia	50.29	15.61	68	17359	54135	63417460
Chronic kidney disease	50.01	15.61	62	17365	45336	63426259
Cardiac failure	47.94	15.61	87	17340	89055	63382540
Dizziness	46.68	15.61	237	17190	429688	63041907
Systemic lupus erythematosus	45.58	15.61	3	17424	208915	63262680
Disturbance in attention	45.06	15.61	54	17373	38135	63433460
Blood glucose abnormal	43.30	15.61	27	17400	7865	63463730
Rash papular	42.64	15.61	35	17392	15667	63455928
Rheumatoid arthritis	42.36	15.61	9	17418	253810	63217785
Drug intolerance	42.19	15.61	16	17411	308645	63162950
Arthropathy	42.00	15.61	7	17420	234785	63236810
Pancreatitis acute	41.60	15.61	44	17383	27122	63444473
Glomerular filtration rate decreased	40.84	15.61	32	17395	13409	63458186
Muscular weakness	40.65	15.61	98	17329	122255	63349340
Lactic acidosis	40.11	15.61	51	17376	38236	63433359
Cognitive disorder	40.06	15.61	62	17365	55753	63415842
Contraindicated product administered	40.04	15.61	6	17421	217642	63253953
Hyperhidrosis	39.79	15.61	90	17337	107746	63363849
Dehydration	37.81	15.61	119	17308	173235	63298360
Diabetic metabolic decompensation	37.44	15.61	15	17412	1695	63469900
Infusion related reaction	36.55	15.61	11	17416	245510	63226085
Pemphigus	36.36	15.61	4	17423	183722	63287873
Therapeutic product effect decreased	36.29	15.61	5	17422	193182	63278413
Amnesia	36.11	15.61	59	17368	55526	63416069
Wound	33.75	15.61	3	17424	163260	63308335
Hypoglycaemic encephalopathy	32.98	15.61	9	17418	303	63471292
Myocardial infarction	31.04	15.61	78	17349	99815	63371780
Drug hypersensitivity	30.96	15.61	24	17403	310663	63160932
Memory impairment	30.93	15.61	80	17347	104178	63367417
Glossodynia	30.54	15.61	6	17421	178870	63292725
Pain	29.87	15.61	104	17323	740524	62731071
Renal failure	29.63	15.61	85	17342	117567	63354028
Pruritus	29.07	15.61	184	17243	361269	63110326
Visual impairment	27.35	15.61	67	17360	84379	63387216
Abdominal pain upper	26.07	15.61	119	17308	206325	63265270
Discomfort	25.82	15.61	7	17420	167367	63304228
Blood glucose decreased	25.32	15.61	30	17397	20922	63450673
Urine calcium/creatinine ratio increased	25.26	15.61	6	17421	114	63471481
Rhabdomyolysis	25.03	15.61	44	17383	43907	63427688
Joint swelling	24.97	15.61	32	17395	327634	63143961
Mucosal membrane hyperplasia	24.71	15.61	5	17422	43	63471552
Vomiting	24.18	15.61	247	17180	559370	62912225
Shock	24.17	15.61	31	17396	23432	63448163
Ketoacidosis	24.07	15.61	15	17412	4363	63467232
Feeling abnormal	23.77	15.61	92	17335	148300	63323295
Heart rate increased	22.68	15.61	67	17360	94171	63377424
Insulin-like growth factor decreased	22.27	15.61	7	17420	389	63471206
Sinusitis	21.95	15.61	18	17409	226635	63244960
Hypersensitivity	21.87	15.61	29	17398	292656	63178939
Product use in unapproved indication	21.73	15.61	11	17416	179069	63292526
Urethral caruncle	21.63	15.61	5	17422	84	63471511
Albuminuria	21.06	15.61	6	17421	237	63471358
Bite	20.93	15.61	7	17420	474	63471121
Lethargy	20.93	15.61	47	17380	55960	63415635
Altered state of consciousness	20.92	15.61	30	17397	25200	63446395
Tachycardia	20.36	15.61	75	17352	118081	63353514
Urinary tract infection	20.18	15.61	133	17294	264551	63207044
Chest pain	19.92	15.61	114	17313	215845	63255750
Hypomagnesaemia	19.33	15.61	31	17396	28706	63442889
Parathyroid hyperplasia	19.11	15.61	5	17422	143	63471452
Blood creatinine increased	18.85	15.61	60	17367	87784	63383811
Lipase increased	18.76	15.61	18	17409	9882	63461713
COVID-19	18.00	15.61	70	17357	113033	63358562
Post procedural infection	17.73	15.61	17	17410	9325	63462270
Malaise	17.64	15.61	183	17244	415771	63055824
Pyelonephritis	17.55	15.61	23	17404	17755	63453840
Condition aggravated	17.17	15.61	55	17372	402162	63069433
Back pain	16.78	15.61	127	17300	264018	63207577
Toxic encephalopathy	16.48	15.61	14	17413	6565	63465030
Intentional product use issue	16.33	15.61	74	17353	127818	63343777
Product use issue	16.31	15.61	22	17405	220498	63251097
Bronchitis	16.19	15.61	7	17420	124928	63346667
Helicobacter infection	16.07	15.61	3	17424	92782	63378813
Staphylococcal sepsis	15.82	15.61	15	17412	8113	63463482

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Pemphigoid	495.32	15.30	190	21288	8476	34926977
Cardiospasm	204.81	15.30	64	21414	1524	34933929
Palmoplantar keratoderma	187.82	15.30	63	21415	1890	34933563
Pruritus genital	180.36	15.30	63	21415	2141	34933312
Sleep terror	177.25	15.30	63	21415	2255	34933198
Blood glucose increased	174.74	15.30	210	21268	66508	34868945
Dermatitis bullous	170.99	15.30	84	21394	6838	34928615
Tension headache	167.64	15.30	65	21413	2977	34932476
Facial pain	155.25	15.30	65	21413	3639	34931814
Atrial tachycardia	152.90	15.30	64	21414	3581	34931872
Carotid artery occlusion	151.36	15.30	64	21414	3673	34931780
Anosmia	146.80	15.30	64	21414	3960	34931493
Pancreatitis	146.14	15.30	148	21330	38743	34896710
Hypoglycaemia	141.40	15.30	171	21307	54469	34880984
Immunisation	137.19	15.30	43	21435	1034	34934419
Glycosylated haemoglobin increased	119.79	15.30	79	21399	11281	34924172
Pain of skin	115.71	15.30	62	21416	6047	34929406
Eye pruritus	106.54	15.30	63	21415	7426	34928027
Subarachnoid haemorrhage	94	15.30	71	21407	12564	34922889
Lip swelling	93.15	15.30	78	21400	16002	34919451
Muscle twitching	92.83	15.30	65	21413	10233	34925220
Pericarditis	87.88	15.30	66	21412	11579	34923874
Vasculitis	87.43	15.30	65	21413	11231	34924222
Blood mercury abnormal	78.86	15.30	20	21458	214	34935239
5-hydroxyindolacetic acid in urine increased	77.00	15.30	20	21458	237	34935216
Ventricular tachycardia	76.67	15.30	88	21390	26491	34908962
Blindness	69.36	15.30	64	21414	14922	34920531
Rash papular	68.26	15.30	54	21424	10224	34925229
Migraine	66.48	15.30	67	21411	17411	34918042
Pericardial disease	65.91	15.30	20	21458	430	34935023
Diplopia	64.86	15.30	65	21413	16778	34918675
Pulmonary valve disease	62.27	15.30	18	21460	325	34935128
Cardiac failure	62.01	15.30	158	21320	91090	34844363
Dry skin	60.68	15.30	85	21393	31202	34904251
Left ventricular dysfunction	58.90	15.30	49	21429	9958	34925495
Alopecia	57.73	15.30	73	21405	24282	34911171
Tinnitus	56.99	15.30	66	21412	20052	34915401
Drug ineffective	55.93	15.30	124	21354	456627	34478826
Euglycaemic diabetic ketoacidosis	50.84	15.30	29	21449	3193	34932260
Palpitations	48.94	15.30	88	21390	39898	34895555
Cerebral infarction	47.98	15.30	71	21407	27384	34908069
Visual impairment	47.98	15.30	82	21396	35720	34899733
Low density lipoprotein decreased	47.69	15.30	20	21458	1123	34934330
Physical examination abnormal	45.92	15.30	14	21464	306	34935147
Diabetic ketoacidosis	45.86	15.30	56	21422	17976	34917477
Transient ischaemic attack	44.83	15.30	69	21409	27544	34907909
Cognitive disorder	44.22	15.30	70	21408	28623	34906830
Abdominal discomfort	44.19	15.30	107	21371	59728	34875725
Diastolic dysfunction	44.12	15.30	34	21444	6193	34929260
Amnesia	44.00	15.30	67	21411	26496	34908957
Disturbance in attention	43.77	15.30	66	21412	25879	34909574
Ventricular hyperkinesia	42.19	15.30	12	21466	204	34935249
Hepatic neoplasm	40.07	15.30	21	21457	1956	34933497
Right atrial enlargement	39.86	15.30	12	21466	251	34935202
Stenosis	39.75	15.30	19	21459	1454	34933999
Mean platelet volume increased	38.98	15.30	14	21464	516	34934937
Angioedema	37.99	15.30	76	21402	37298	34898155
Hypochromasia	37.50	15.30	12	21466	309	34935144
Electrocardiogram Q wave abnormal	37.37	15.30	13	21465	436	34935017
Cardiac discomfort	36.93	15.30	14	21464	602	34934851
Hyperglycaemia	36.27	15.30	77	21401	39403	34896050
Diabetic nephropathy	35.87	15.30	20	21458	2108	34933345
Product use in unapproved indication	35.31	15.30	14	21464	117485	34817968
Mitral valve thickening	35.09	15.30	12	21466	382	34935071
Pruritus	34.95	15.30	176	21302	141805	34793648
Rales	34.17	15.30	36	21442	9847	34925606
Hepatojugular reflux	33.67	15.30	13	21465	588	34934865
Completed suicide	32.41	15.30	10	21468	98158	34837295
Pancreatic carcinoma	31.80	15.30	33	21445	8868	34926585
Drug abuse	31.12	15.30	11	21467	99085	34836368
Tricuspid valve incompetence	31.01	15.30	34	21444	9726	34925727
Aortic valve incompetence	30.84	15.30	27	21451	5877	34929576
Blood glucose abnormal	30.65	15.30	27	21451	5925	34929528
Renal impairment	30.56	15.30	127	21351	94386	34841067
Dehydration	30.50	15.30	159	21319	129810	34805643
Memory impairment	29.37	15.30	75	21403	43243	34892210
Occult blood	29.05	15.30	13	21465	855	34934598
Death	29.03	15.30	136	21342	397913	34537540
Abdominal pain upper	28.79	15.30	103	21375	71387	34864066
Mitral valve disease	28.55	15.30	15	21463	1404	34934049
Left ventricular enlargement	28.34	15.30	12	21466	690	34934763
Expired product administered	27.59	15.30	20	21458	3321	34932132
Helicobacter gastritis	27.56	15.30	14	21464	1222	34934231
Necrotising oesophagitis	27.35	15.30	11	21467	555	34934898
Haemoglobin increased	27.23	15.30	20	21458	3389	34932064
Pancreatitis acute	27.14	15.30	56	21422	28085	34907368
Bundle branch block left	26.63	15.30	25	21453	5954	34929499
Mucosal dryness	26.59	15.30	14	21464	1317	34934136
Echocardiogram abnormal	26.54	15.30	13	21465	1050	34934403
Acute kidney injury	26.07	15.30	294	21184	304694	34630759
Hypoglycaemic coma	25.84	15.30	17	21461	2414	34933039
Hypovolaemia	25.65	15.30	30	21448	9204	34926249
Haematocrit increased	25.49	15.30	16	21462	2097	34933356
Left atrial enlargement	25.42	15.30	12	21466	893	34934560
Mitral valve incompetence	25.18	15.30	38	21440	14905	34920548
Dyspnoea at rest	25.17	15.30	20	21458	3808	34931645
Hallucination	24.98	15.30	79	21399	51419	34884034
Hypohidrosis	24.78	15.30	8	21470	212	34935241
Neoplasm	24.62	15.30	23	21455	5444	34930009
Chronic kidney disease	24.54	15.30	68	21410	41142	34894311
Pericardial haemorrhage	24.04	15.30	18	21460	3140	34932313
Peak expiratory flow rate decreased	23.93	15.30	7	21471	132	34935321
Bronchitis viral	23.29	15.30	8	21470	258	34935195
Blood iron decreased	23.25	15.30	22	21456	5291	34930162
Ventricular arrhythmia	22.51	15.30	22	21456	5506	34929947
Acute lung injury	22.25	15.30	13	21465	1497	34933956
Neutropenia	22.14	15.30	39	21439	156739	34778714
Heart rate increased	21.48	15.30	70	21408	46273	34889180
Left atrial dilatation	21.32	15.30	14	21464	1982	34933471
Poikilocytosis	21.29	15.30	7	21471	197	34935256
Disease progression	21.28	15.30	21	21457	108056	34827397
Intentional product misuse	21.24	15.30	69	21409	45542	34889911
General physical health deterioration	20.88	15.30	29	21449	128240	34807213
Hyperkalaemia	20.69	15.30	91	21387	69298	34866155
Carotid artery stenosis	20.48	15.30	20	21458	4999	34930454
Left ventricular hypertrophy	20.27	15.30	25	21453	8105	34927348
Depression	20.13	15.30	18	21460	97080	34838373
Carotid arteriosclerosis	19.77	15.30	13	21465	1845	34933608
Febrile neutropenia	19.36	15.30	34	21444	136815	34798638
Diabetic ketoacidotic hyperglycaemic coma	18.92	15.30	6	21472	150	34935303
Tachycardia	18.70	15.30	102	21376	84670	34850783
Eosinophilic pneumonia	18.26	15.30	16	21462	3485	34931968
Chills	18.06	15.30	14	21464	81029	34854424
Seizure	17.78	15.30	23	21455	104834	34830619
Electrocardiogram T wave inversion	17.62	15.30	13	21465	2218	34933235
Amylase increased	17.60	15.30	20	21458	5948	34929505
Hyperaesthesia teeth	17.49	15.30	8	21470	554	34934899
Pancytopenia	17.05	15.30	20	21458	95137	34840316
Supraventricular tachycardia	16.95	15.30	27	21451	11090	34924363
Diabetes mellitus inadequate control	16.93	15.30	30	21448	13434	34922019
Hypertensive heart disease	16.74	15.30	13	21465	2395	34933058
Toxicity to various agents	16.67	15.30	65	21413	200297	34735156
Lactic acidosis	16.54	15.30	53	21425	34719	34900734
Glomerular filtration rate decreased	16.45	15.30	29	21449	12932	34922521
Muscular weakness	16.27	15.30	88	21390	72809	34862644
Somnolence	16.26	15.30	27	21451	111089	34824364
Chest pain	16.13	15.30	133	21345	126629	34808824
Anaemia macrocytic	16.13	15.30	14	21464	3012	34932441
Interstitial lung disease	16.08	15.30	81	21397	65201	34870252
Feeling abnormal	15.96	15.30	79	21399	63156	34872297
Off label use	15.95	15.30	173	21305	419351	34516102
Bronchial hyperreactivity	15.89	15.30	11	21467	1698	34933755
Malaise	15.76	15.30	179	21299	185646	34749807
Blindness transient	15.43	15.30	12	21466	2214	34933239
Respiratory symptom	15.39	15.30	11	21467	1786	34933667
Systolic dysfunction	15.39	15.30	13	21465	2695	34932758
Red blood cell count decreased	15.38	15.30	46	21432	29044	34906409

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Pemphigoid	683.21	13.71	258	35798	15057	79693275
Cardiospasm	377.61	13.71	113	35943	3188	79705144
Palmoplantar keratoderma	360.21	13.71	112	35944	3604	79704728
Pruritus genital	351.54	13.71	115	35941	4371	79703961
Sleep terror	340.15	13.71	112	35944	4346	79703986
Blood glucose increased	312.72	13.71	319	35737	114656	79593676
Tension headache	298.19	13.71	115	35941	7096	79701236
Atrial tachycardia	295.83	13.71	114	35942	7019	79701313
Subarachnoid haemorrhage	295.01	13.71	166	35890	24299	79684033
Hypoglycaemia	292.98	13.71	291	35765	101303	79607029
Carotid artery occlusion	288.13	13.71	114	35942	7533	79700799
Anosmia	272.09	13.71	114	35942	8730	79699602
Immunisation	242.75	13.71	73	35983	2094	79706238
Facial pain	238.63	13.71	115	35941	12235	79696097
Dermatitis bullous	237.60	13.71	120	35936	14125	79694207
Pain of skin	217.44	13.71	114	35942	14499	79693833
Eye pruritus	191.26	13.71	118	35938	20452	79687880
Pancreatitis	183.98	13.71	189	35867	68386	79639946
Vasculitis	176.88	13.71	121	35935	24981	79683351
Ventricular tachycardia	175.31	13.71	148	35908	41787	79666545
Glycosylated haemoglobin increased	167.75	13.71	106	35950	19154	79689178
Muscle twitching	166.55	13.71	116	35940	24648	79683684
Blindness	163.49	13.71	121	35935	28262	79680070
Lip swelling	156.01	13.71	137	35919	40774	79667558
Drug ineffective	136.42	13.71	174	35882	1080739	78627593
Diplopia	129.46	13.71	113	35943	33353	79674979
Dry skin	117.10	13.71	149	35907	67846	79640486
Tinnitus	116.72	13.71	121	35935	44212	79664120
Euglycaemic diabetic ketoacidosis	115.12	13.71	58	35998	6786	79701546
Cardiac failure	112.74	13.71	229	35827	154613	79553719
Acute kidney injury	112.15	13.71	498	35558	518906	79189426
Rash papular	109.83	13.71	86	35970	21830	79686502
Transient ischaemic attack	109.50	13.71	127	35929	52568	79655764
Angioedema	108.51	13.71	152	35904	75883	79632449
Diabetic ketoacidosis	106.19	13.71	102	35954	34020	79674312
Disturbance in attention	93.33	13.71	115	35941	50686	79657646
Hallucination	90.54	13.71	149	35907	85596	79622736
Renal impairment	86.18	13.71	208	35848	157575	79550757
Hyperglycaemia	84.98	13.71	130	35926	70205	79638127
Blood mercury abnormal	84.95	13.71	20	36036	214	79708118
5-hydroxyindolacetic acid in urine increased	82.93	13.71	20	36036	239	79708093
Chronic kidney disease	80.95	13.71	123	35933	66031	79642301
Intentional product misuse	80.50	13.71	150	35906	95015	79613317
Palpitations	80.24	13.71	177	35879	126433	79581899
Cognitive disorder	79.95	13.71	126	35930	69800	79638532
Amnesia	76.81	13.71	117	35939	62940	79645392
Pancreatic carcinoma	71.77	13.71	55	36001	13522	79694810
Dehydration	70.99	13.71	260	35796	247927	79460405
Pulmonary valve disease	69.66	13.71	18	36038	290	79708042
Pericardial disease	66.72	13.71	20	36036	567	79707765
Visual impairment	66.70	13.71	136	35920	91995	79616337
Hyperkalaemia	65.89	13.71	154	35902	114244	79594088
Product use in unapproved indication	62.23	13.71	18	36038	250341	79457991
Hyperlactacidaemia	62.14	13.71	36	36020	5559	79702773
Diabetes mellitus inadequate control	61.66	13.71	65	35991	24199	79684133
Memory impairment	56.43	13.71	143	35913	111591	79596741
Metabolic acidosis	56.42	13.71	119	35937	82410	79625922
Therapeutic product effect decreased	55.68	13.71	5	36051	163858	79544474
Completed suicide	55.25	13.71	21	36035	245746	79462586
Infusion related reaction	54.61	13.71	18	36038	230219	79478113
Cerebral infarction	54.56	13.71	84	35972	45592	79662740
Arthropathy	53.72	13.71	8	36048	177103	79531229
Synovitis	52.87	13.71	4	36052	150730	79557602
Migraine	52.81	13.71	120	35936	87373	79620959
Low density lipoprotein decreased	52.35	13.71	20	36036	1201	79707131
Drug hypersensitivity	51.67	13.71	36	36020	298880	79409452
Treatment failure	51.03	13.71	8	36048	170478	79537854
Glomerular filtration rate decreased	51.01	13.71	57	35999	22645	79685687
Muscular weakness	50.73	13.71	174	35882	160555	79547777
Physical examination abnormal	50.64	13.71	14	36042	295	79708037
Pruritus	50.43	13.71	328	35728	394320	79314012
Rheumatoid arthritis	49.97	13.71	16	36040	208454	79499878
Lactic acidosis	49.90	13.71	103	35953	70256	79638076
Left ventricular dysfunction	47.66	13.71	51	36005	19310	79689022
Cystostomy	44.87	13.71	10	36046	82	79708250
Pancreatitis acute	42.94	13.71	79	35977	49525	79658807
Hyperhidrosis	42.67	13.71	158	35898	151334	79556998
Ventricular hyperkinesia	41.97	13.71	12	36044	287	79708045
Blood glucose abnormal	41.50	13.71	36	36020	10530	79697802
Diabetic nephropathy	41.03	13.71	22	36034	2925	79705407
Drug intolerance	40.35	13.71	36	36020	264083	79444249
Diastolic dysfunction	38.80	13.71	35	36021	10776	79697556
Right atrial enlargement	38.67	13.71	12	36044	383	79707949
Mitral valve thickening	37.75	13.71	12	36044	415	79707917
Depression	37.59	13.71	26	36030	216764	79491568
Electrocardiogram Q wave abnormal	36.96	13.71	13	36043	617	79707715
Heart rate increased	36.61	13.71	129	35927	120595	79587737
Hepatojugular reflux	36.60	13.71	13	36043	635	79707697
Stenosis	36.32	13.71	19	36037	2403	79705929
Systemic lupus erythematosus	35.54	13.71	6	36050	121143	79587189
Hepatic neoplasm	35.30	13.71	21	36035	3405	79704927
Haemoglobin increased	34.98	13.71	26	36030	6106	79702226
Pericarditis	34.78	13.71	115	35941	104121	79604211
Cardiac discomfort	34.32	13.71	15	36041	1273	79707059
Abdominal pain upper	34.22	13.71	195	35861	223624	79484708
Tachycardia	34.15	13.71	165	35891	177603	79530729
Renal failure	34.02	13.71	180	35876	200788	79507544
Hypoglycaemic coma	33.65	13.71	23	36033	4737	79703595
Myocardial infarction	33.30	13.71	168	35888	183961	79524371
Hypersensitivity	33.06	13.71	42	36014	262197	79446135
Mean platelet volume increased	32.98	13.71	14	36042	1106	79707226
COVID-19	32.21	13.71	149	35907	157525	79550807
Hypochromasia	32.01	13.71	12	36044	684	79707648
Sinusitis	31.88	13.71	25	36031	195476	79512856
Blood iron decreased	31.71	13.71	37	36019	15397	79692935
Contraindicated product administered	31.38	13.71	16	36040	157522	79550810
Ketoacidosis	31.33	13.71	27	36029	7827	79700505
Left ventricular enlargement	31.20	13.71	12	36044	734	79707598
Feeling abnormal	30.74	13.71	148	35908	159051	79549281
Aortic valve incompetence	30.61	13.71	29	36027	9501	79698831
Left ventricular hypertrophy	30.26	13.71	31	36025	11160	79697172
Neutropenia	29.58	13.71	53	36003	287657	79420675
Wound	29.50	13.71	8	36048	116171	79592161
Pain	28.93	13.71	193	35863	703609	79004723
Toxicity to various agents	28.20	13.71	97	35959	421443	79286889
Diabetic metabolic decompensation	28.16	13.71	18	36038	3314	79705018
Chest pain	27.53	13.71	220	35836	282084	79426248
Haematocrit increased	27.35	13.71	19	36037	4015	79704317
Dizziness	27.17	13.71	360	35696	526081	79182251
Pain in extremity	27.10	13.71	80	35976	364458	79343874
Hepatic enzyme increased	26.57	13.71	26	36030	182584	79525748
Interstitial lung disease	26.48	13.71	111	35945	112489	79595843
Glossodynia	26.46	13.71	7	36049	103330	79605002
Altered state of consciousness	26.31	13.71	60	35996	43762	79664570
Tricuspid valve incompetence	26.03	13.71	38	36018	19674	79688658
Left atrial enlargement	25.67	13.71	12	36044	1191	79707141
Expired product administered	25.64	13.71	23	36033	7028	79701304
Hypoglycaemic encephalopathy	25.40	13.71	10	36046	651	79707681
Haemodynamic instability	25.15	13.71	35	36021	17347	79690985
Hypohidrosis	24.83	13.71	8	36048	289	79708043
End stage renal disease	24.61	13.71	29	36027	12191	79696141
Occult blood	24.37	13.71	13	36043	1710	79706622
Chills	24.26	13.71	22	36034	160212	79548120
Rales	24.18	13.71	37	36019	19964	79688368
Swelling	24.04	13.71	38	36018	216673	79491659
Drug abuse	23.86	13.71	23	36033	162668	79545664
Lipase increased	23.59	13.71	33	36023	16433	79691899
Necrotising oesophagitis	23.44	13.71	11	36045	1102	79707230
Pericardial haemorrhage	23.30	13.71	18	36038	4477	79703855
Helicobacter gastritis	22.63	13.71	14	36042	2435	79705897
Diabetic ketoacidotic hyperglycaemic coma	22.60	13.71	7	36049	222	79708110
Therapy non-responder	22.25	13.71	7	36049	92298	79616034
General physical health deterioration	22.23	13.71	58	35998	275180	79433152
Mucosal membrane hyperplasia	22.12	13.71	5	36051	44	79708288
Diabetic foot	22.07	13.71	16	36040	3616	79704716
Hepatic function abnormal	22.05	13.71	78	35978	73029	79635303
Contusion	21.85	13.71	21	36035	148755	79559577
Carotid arteriosclerosis	21.59	13.71	14	36042	2642	79705690
Mitral valve disease	21.54	13.71	15	36041	3182	79705150
Echocardiogram abnormal	21.26	13.71	13	36043	2215	79706117
Ventricular arrhythmia	21.25	13.71	23	36033	8817	79699515
Urine calcium/creatinine ratio increased	21.04	13.71	6	36050	142	79708190
Bundle branch block left	21.03	13.71	26	36030	11487	79696845
Joint swelling	20.97	13.71	64	35992	288582	79419750
Neoplasm	20.67	13.71	23	36033	9093	79699239
Discomfort	20.55	13.71	16	36040	125601	79582731
Penile oedema	20.32	13.71	7	36049	312	79708020
Amylase increased	19.97	13.71	25	36031	11184	79697148
Urethral caruncle	19.74	13.71	5	36051	74	79708258
Intentional product use issue	19.72	13.71	127	35929	151985	79556347
Psoriasis	19.55	13.71	8	36048	89579	79618753
Product use issue	19.51	13.71	41	36015	209781	79498551
Poikilocytosis	19.42	13.71	7	36049	357	79707975
Left atrial dilatation	19.41	13.71	14	36042	3139	79705193
Malaise	19.37	13.71	320	35736	489549	79218783
Dyspnoea at rest	19.33	13.71	20	36036	7282	79701050
Renal disorder	19.30	13.71	52	36004	42053	79666279
Mitral valve incompetence	19.29	13.71	41	36015	28524	79679808
Back pain	19.12	13.71	216	35840	303964	79404368
Hypovolaemia	19.00	13.71	31	36025	17660	79690672
Psoriatic arthropathy	18.65	13.71	6	36050	77993	79630339
Pemphigus	18.54	13.71	11	36045	99571	79608761
Pancytopenia	18.44	13.71	29	36027	165716	79542616
Peak expiratory flow rate decreased	18.35	13.71	8	36048	675	79707657
Marasmus	18.14	13.71	9	36047	1019	79707313
Nasopharyngitis	17.93	13.71	57	35999	253824	79454508
Mucosal dryness	17.90	13.71	14	36042	3545	79704787
Product dose omission issue	17.89	13.71	55	36001	247482	79460850
Mucosal inflammation	17.75	13.71	6	36050	75574	79632758
Acute myocardial infarction	17.38	13.71	75	35981	76961	79631371
Acute lung injury	17.36	13.71	13	36043	3087	79705245
Helicobacter infection	17.32	13.71	5	36051	69699	79638633
Vomiting	17.24	13.71	408	35648	665420	79042912
Condition aggravated	16.95	13.71	145	35911	500979	79207353
Blood creatinine increased	16.86	13.71	124	35932	154933	79553399
Sputum discoloured	16.80	13.71	33	36023	21710	79686622
Bite	16.69	13.71	7	36049	537	79707795
Electrocardiogram T wave inversion	16.59	13.71	16	36040	5356	79702976
Erythema multiforme	16.40	13.71	29	36027	17622	79690710
Carotid artery stenosis	16.35	13.71	20	36036	8738	79699594
Insulin-like growth factor decreased	16.20	13.71	7	36049	578	79707754
Parathyroid hyperplasia	15.70	13.71	5	36051	174	79708158
Epidermolysis	15.68	13.71	8	36048	960	79707372
Diabetes mellitus	15.21	13.71	73	35983	78317	79630015
Systolic dysfunction	15.04	13.71	13	36043	3782	79704550
Coma	15.02	13.71	14	36042	100635	79607697
Gastrointestinal disorder	14.95	13.71	20	36036	122185	79586147
Supraventricular tachycardia	14.91	13.71	31	36025	21239	79687093
Suicidal ideation	14.83	13.71	8	36048	76332	79632000
Flushing	14.75	13.71	11	36045	88257	79620075
Weight increased	14.64	13.71	70	35986	277316	79431016
Pyelonephritis	14.62	13.71	30	36026	20358	79687974
Antibiotic level above therapeutic	14.62	13.71	7	36049	733	79707599
Albuminuria	14.54	13.71	7	36049	742	79707590
Heart rate decreased	14.21	13.71	7	36049	70309	79638023
Bronchitis viral	14.18	13.71	8	36048	1175	79707157
Injection site pain	14.17	13.71	23	36033	129815	79578517
Latent autoimmune diabetes in adults	14.14	13.71	4	36052	92	79708240
Drug ineffective for unapproved indication	14.04	13.71	3	36053	51235	79657097
Immune-mediated myositis	13.99	13.71	12	36044	3455	79704877
Hypertensive heart disease	13.89	13.71	13	36043	4193	79704139
Arthritis	13.85	13.71	19	36037	114861	79593471
Bone pain	13.85	13.71	4	36052	55738	79652594
Folliculitis	13.71	13.71	4	36052	55376	79652956

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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 level	Dissociation constant	Type (acidic/basic)
pKa1	9.16	Basic
pKa2	6.13	Basic
pKa3	3.79	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent 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 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 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 COMPRISING METFORMIN 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
10MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	11564886	March 7, 2032	TREATMENT OF A TYPE 2 DIABETES 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 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 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	11564886	March 7, 2032	TREATMENT OF A TYPE 2 DIABETES 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 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 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 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 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	11564886	March 7, 2032	TREATMENT OF A TYPE 2 DIABETES 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 strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
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
5MG	TRADJENTA	BOEHRINGER INGELHEIM	N201280	May 2, 2011	RX	TABLET	ORAL	June 20, 2026	REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1218-0091, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
2.5MG;1GM	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	June 20, 2026	REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1218-0091, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
2.5MG;500MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	June 20, 2026	REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1218-0091, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
2.5MG;850MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	June 20, 2026	REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1218-0091, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
2.5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	June 20, 2026	REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1218-0091, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	June 20, 2026	REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1218-0091, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
5MG	TRADJENTA	BOEHRINGER INGELHEIM	N201280	May 2, 2011	RX	TABLET	ORAL	Dec. 20, 2026	PEDIATRIC EXCLUSIVITY
2.5MG;1GM	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	Dec. 20, 2026	PEDIATRIC EXCLUSIVITY
2.5MG;500MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	Dec. 20, 2026	PEDIATRIC EXCLUSIVITY
2.5MG;850MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	Dec. 20, 2026	PEDIATRIC EXCLUSIVITY
2.5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	Dec. 20, 2026	PEDIATRIC EXCLUSIVITY
5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	Dec. 20, 2026	PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Dipeptidyl peptidase 4	Enzyme	P27487	DPP4_HUMAN	INHIBITOR	IC50	10	CHEMBL	CHEMBL
Muscarinic acetylcholine receptor M1	GPCR	P11229	ACM1_HUMAN		IC50	6.53	CHEMBL
Prolyl endopeptidase FAP	Enzyme	Q12884	SEPR_HUMAN		IC50	7.05	CHEMBL
Dipeptidyl peptidase 9	Enzyme	Q86TI2	DPP9_HUMAN		IC50	4	CHEMBL
Prolyl endopeptidase FAP	Enzyme		SEPR_MOUSE		IC50	6.43	CHEMBL
Dipeptidyl peptidase IV	Unclassified		O31048_PORGN		IC50	5	CHEMBL

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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
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	0597-0146	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	0597-0147	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
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	0597-0270	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
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