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

Stem definition	Drug id	CAS RN
HIV protease inhibitors	4143	206361-99-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: darunavir darunavir ethanolate prezista TMC-114 TMC 114 darunavir ethnolate	An HIV PROTEASE INHIBITOR that is used in the treatment of AIDS and HIV INFECTIONS. Due to the emergence of ANTIVIRAL DRUG RESISTANCE when used alone, it is administered in combination with other ANTI-HIV AGENTS. There was some evidence of in vitro activity against SARS-CoV-2, but no clinical trial data was found to support use in the treatment of COVID-19. Molecular weight: 547.67 Formula: C27H37N3O7S CLOGP: 2.89 LIPINSKI: 1 HAC: 10 HDO: 3 TPSA: 140.42 ALOGS: -3.91 ROTB: 11 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

darunavir
darunavir ethanolate
prezista
TMC-114
TMC 114
darunavir ethnolate

An HIV PROTEASE INHIBITOR that is used in the treatment of AIDS and HIV INFECTIONS. Due to the emergence of ANTIVIRAL DRUG RESISTANCE when used alone, it is administered in combination with other ANTI-HIV AGENTS. There was some evidence of in vitro activity against SARS-CoV-2, but no clinical trial data was found to support use in the treatment of COVID-19.

Molecular weight: 547.67
Formula: C27H37N3O7S
CLOGP: 2.89
LIPINSKI: 1
HAC: 10
HDO: 3
TPSA: 140.42
ALOGS: -3.91
ROTB: 11

Status: OFP

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

Drug dosage:

Dose	Unit	Route
1.20	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.15 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	1.20 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	20.87 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	37 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
CL (Clearance)	7.81 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.05 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	15 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company
Feb. 12, 2007	EMA	Janssen-Cilag International NV
June 23, 2006	FDA	JANSSEN PRODS
Nov. 22, 2007	PMDA	Janssen Pharmaceutical K.K.

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
Exposure during pregnancy	935.38	27.75	451	8699	155096	63324776
Foetal exposure during pregnancy	837.66	27.75	270	8880	31692	63448180
Abortion spontaneous	741.99	27.75	272	8878	46923	63432949
Maternal exposure during pregnancy	356.17	27.75	276	8874	219786	63260086
Virologic failure	281.38	27.75	63	9087	1799	63478073
Premature labour	244.75	27.75	85	9065	12419	63467453
Premature baby	237.07	27.75	95	9055	20640	63459232
Live birth	214.39	27.75	94	9056	25536	63454336
Drug interaction	209.51	27.75	208	8942	228923	63250949
Treatment noncompliance	204.02	27.75	102	9048	37223	63442649
Premature delivery	193.24	27.75	92	9058	30189	63449683
Viral mutation identified	187.14	27.75	45	9105	1765	63478107
Abortion induced	163.96	27.75	60	9090	10182	63469690
Foetal growth restriction	161.99	27.75	55	9095	7498	63472374
Blood HIV RNA increased	156.46	27.75	33	9117	706	63479166
Foetal death	152.64	27.75	58	9092	10922	63468950
Lipodystrophy acquired	149.60	27.75	36	9114	1416	63478456
Immune reconstitution inflammatory syndrome	141.13	27.75	47	9103	6037	63473835
Viral load increased	136.08	27.75	33	9117	1341	63478531
Spina bifida	129.41	27.75	29	9121	830	63479042
Stillbirth	128.62	27.75	45	9105	6705	63473167
Pathogen resistance	127.10	27.75	44	9106	6354	63473518
Premature rupture of membranes	121.52	27.75	40	9110	4953	63474919
Genotype drug resistance test positive	101.28	27.75	21	9129	412	63479460
Low birth weight baby	100.30	27.75	38	9112	7091	63472781
Hepatocellular injury	99.31	27.75	57	9093	27324	63452548
Drug resistance	97.51	27.75	53	9097	22880	63456992
Supernumerary nipple	96.17	27.75	15	9135	48	63479824
Caesarean section	94.32	27.75	47	9103	16985	63462887
Congenital naevus	92.55	27.75	17	9133	171	63479701
Acoustic stimulation tests abnormal	89.86	27.75	15	9135	81	63479791
Anal atresia	85.55	27.75	18	9132	380	63479492
Congenital genital malformation	82.58	27.75	15	9135	141	63479731
Cloacal exstrophy	81.65	27.75	15	9135	151	63479721
Low set ears	80.36	27.75	16	9134	254	63479618
Cholestasis of pregnancy	79.55	27.75	21	9129	1204	63478668
Bladder agenesis	75.84	27.75	14	9136	145	63479727
Genitalia external ambiguous	75.24	27.75	14	9136	152	63479720
Caudal regression syndrome	74.35	27.75	14	9136	163	63479709
Meconium stain	72.57	27.75	14	9136	187	63479685
Congenital heart valve disorder	70.95	27.75	12	9138	71	63479801
Gastrointestinal disorder congenital	70.75	27.75	13	9137	131	63479741
Tethered cord syndrome	67.74	27.75	14	9136	270	63479602
CD4 lymphocytes decreased	67.22	27.75	19	9131	1408	63478464
Pain	66.85	27.75	13	9137	740615	62739257
Sudden infant death syndrome	66.56	27.75	14	9136	295	63479577
Gastroschisis	62.18	27.75	14	9136	409	63479463
Meningomyelocele	62.00	27.75	15	9135	603	63479269
Gastrointestinal malformation	61.16	27.75	12	9138	176	63479696
Congenital pulmonary valve disorder	60.71	27.75	10	9140	49	63479823
Congenital choroid plexus cyst	60.19	27.75	13	9137	312	63479560
Cerebral ventricle dilatation	59.06	27.75	16	9134	1013	63478859
Congenital anomaly	58.83	27.75	18	9132	1758	63478114
Exomphalos	58.35	27.75	14	9136	543	63479329
Gestational diabetes	58.09	27.75	27	9123	8369	63471503
Umbilical cord abnormality	55.93	27.75	14	9136	649	63479223
Coloboma	55.54	27.75	10	9140	89	63479783
CSF HIV escape syndrome	54.77	27.75	10	9140	97	63479775
Hyperadrenocorticism	53.62	27.75	12	9138	341	63479531
Hemivertebra	52.90	27.75	10	9140	119	63479753
Fatigue	52.13	27.75	32	9118	887996	62591876
Foetal malnutrition	48.86	27.75	9	9141	92	63479780
Cushingoid	48.70	27.75	24	9126	8461	63471411
Neonatal respiratory arrest	47.20	27.75	8	9142	48	63479824
Ventricular septal defect	46.34	27.75	19	9131	4359	63475513
Ichthyosis	46.26	27.75	8	9142	55	63479817
Nephropathy toxic	46.18	27.75	24	9126	9455	63470417
Foetal growth abnormality	46.01	27.75	8	9142	57	63479815
Hepatitis B DNA increased	45.43	27.75	10	9140	263	63479609
Eosinophilia	44.22	27.75	32	9118	22724	63457148
Complication of delivery	43.93	27.75	9	9141	166	63479706
Pulmonary valve sclerosis	43.08	27.75	7	9143	31	63479841
Maternal drugs affecting foetus	43.05	27.75	19	9131	5223	63474649
Rash maculo-papular	42.74	27.75	36	9114	31860	63448012
Neural tube defect	42.64	27.75	9	9141	193	63479679
Congenital ectopic bladder	42.03	27.75	8	9142	99	63479773
Pre-eclampsia	41.30	27.75	22	9128	9111	63470761
Lipohypertrophy	41.28	27.75	11	9139	654	63479218
Renal tubular disorder	40.28	27.75	15	9135	2667	63477205
Oligohydramnios	39.52	27.75	19	9131	6347	63473525
Left ventricular dilatation	39.39	27.75	10	9140	491	63479381
Adrenal insufficiency	38.99	27.75	27	9123	17888	63461984
Anencephaly	38.89	27.75	9	9141	298	63479574
Drug ineffective	38.69	27.75	57	9093	1044708	62435164
Endometritis decidual	38.51	27.75	6	9144	19	63479853
Amniotic cavity infection	38.45	27.75	12	9138	1251	63478621
Cholestasis	36.95	27.75	32	9118	29402	63450470
Dermatitis exfoliative generalised	35.19	27.75	15	9135	3792	63476080
Atrial septal defect	35.04	27.75	18	9132	6920	63472952
Psychomotor retardation	34.95	27.75	15	9135	3855	63476017
Central obesity	34.67	27.75	11	9139	1210	63478662
HIV-associated neurocognitive disorder	34.07	27.75	7	9143	131	63479741
Acute kidney injury	34.06	27.75	99	9051	263316	63216556
Total bile acids increased	33.82	27.75	7	9143	136	63479736
Potassium wasting nephropathy	33.68	27.75	6	9144	50	63479822
Skin striae	33.18	27.75	11	9139	1390	63478482
CSF test abnormal	33.15	27.75	8	9142	318	63479554
Fall	33.03	27.75	8	9142	392326	63087546
Congenital anomaly in offspring	32.78	27.75	7	9143	159	63479713
Generalised anxiety disorder	32.62	27.75	12	9138	2062	63477810
Complication of pregnancy	32.61	27.75	9	9141	611	63479261
Alopecia	32.37	27.75	5	9145	337531	63142341
Polyhydramnios	31.56	27.75	12	9138	2259	63477613
Mental disability	30.90	27.75	6	9144	83	63479789
Foetal heart rate disorder	30.64	27.75	6	9144	87	63479785
Abortion	30.46	27.75	12	9138	2484	63477388
Breast disorder	30.30	27.75	12	9138	2518	63477354
Sepsis neonatal	30.14	27.75	8	9142	468	63479404
Large for dates baby	30.03	27.75	8	9142	475	63479397
Ventricular hypertrophy	29.99	27.75	13	9137	3423	63476449
Congenital intestinal malformation	29.36	27.75	5	9145	31	63479841
Glucocorticoids increased	28.54	27.75	6	9144	126	63479746
Dyslipidaemia	28.42	27.75	16	9134	7377	63472495
Fanconi syndrome acquired	28.04	27.75	9	9141	1027	63478845

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
Immune reconstitution inflammatory syndrome	526.58	15.47	185	16022	8574	34932150
Foetal exposure during pregnancy	474.95	15.47	266	15941	37835	34902889
Lipodystrophy acquired	412.59	15.47	122	16085	3222	34937502
Drug interaction	338.37	15.47	466	15741	225480	34715244
Mitochondrial toxicity	309.19	15.47	93	16114	2606	34938118
Progressive external ophthalmoplegia	294.46	15.47	78	16129	1357	34939367
Virologic failure	294.06	15.47	95	16112	3385	34937339
Eyelid ptosis	247.14	15.47	95	16112	5671	34935053
Viral mutation identified	179.69	15.47	63	16144	2891	34937833
Blood HIV RNA increased	169.86	15.47	49	16158	1181	34939543
Osteoporosis	156.29	15.47	88	16119	12580	34928144
Pathogen resistance	153.78	15.47	79	16128	9403	34931321
Diplopia	145.43	15.47	93	16114	16750	34923974
Drug resistance	132.69	15.47	104	16103	25823	34914901
Viral load increased	131.46	15.47	48	16159	2479	34938245
Genotype drug resistance test positive	116.37	15.47	36	16171	1109	34939615
Premature baby	114.18	15.47	85	16122	19548	34921176
CD4 lymphocytes decreased	113.09	15.47	39	16168	1702	34939022
Renal tubular disorder	109.49	15.47	50	16157	4593	34936131
HIV-associated neurocognitive disorder	101.55	15.47	25	16182	319	34940405
Dyslipidaemia	92.29	15.47	52	16155	7436	34933288
Syphilis	86.11	15.47	23	16184	413	34940311
Brain stem stroke	82.78	15.47	21	16186	305	34940419
Laryngomalacia	82.40	15.47	21	16186	311	34940413
Trisomy 21	79.34	15.47	23	16184	564	34940160
Gene mutation	77.92	15.47	28	16179	1380	34939344
Hypertriglyceridaemia	73.76	15.47	47	16160	8401	34932323
Ophthalmoplegia	70.63	15.47	28	16179	1812	34938912
Adrenal suppression	64.31	15.47	20	16187	627	34940097
Osteonecrosis	64.05	15.47	54	16153	14836	34925888
Polydactyly	62.93	15.47	23	16184	1190	34939534
Treatment noncompliance	60.83	15.47	70	16137	28030	34912694
Fanconi syndrome acquired	58.41	15.47	25	16182	1966	34938758
Drug reaction with eosinophilia and systemic symptoms	58.03	15.47	74	16133	32938	34907786
Nephropathy toxic	54.86	15.47	46	16161	12542	34928182
Pyelocaliectasis	53.38	15.47	20	16187	1110	34939614
Mycobacterium avium complex infection	52.85	15.47	25	16182	2486	34938238
Genital herpes	52.26	15.47	17	16190	618	34940106
CSF HIV escape syndrome	51.29	15.47	13	16194	188	34940536
Ventricular hypoplasia	50.99	15.47	11	16196	74	34940650
Anogenital dysplasia	50.62	15.47	12	16195	129	34940595
Dyspnoea	49.91	15.47	61	16146	376721	34564003
Congenital hydronephrosis	49.86	15.47	17	16190	716	34940008
Atrioventricular septal defect	49.33	15.47	13	16194	221	34940503
Hemivertebra	49.19	15.47	12	16195	147	34940577
Hepatitis cholestatic	47.51	15.47	35	16172	7912	34932812
Nephrolithiasis	47.12	15.47	64	16143	30269	34910455
Hepatitis B	44.23	15.47	30	16177	5953	34934771
Renal impairment	43.88	15.47	119	16088	94394	34846330
Genital herpes simplex	41.26	15.47	10	16197	119	34940605
Rash maculo-papular	41.15	15.47	58	16149	28393	34912331
Karyotype analysis abnormal	38.16	15.47	8	16199	46	34940678
Drug level increased	37.98	15.47	49	16158	22047	34918677
Hepatitis C	36.91	15.47	33	16174	9797	34930927
Hepatocellular injury	36.23	15.47	48	16159	22163	34918561
Oesophageal atresia	35.30	15.47	12	16195	501	34940223
Ectopic kidney	35.29	15.47	7	16200	29	34940695
Atrial fibrillation	35.17	15.47	7	16200	122386	34818338
Low birth weight baby	34.67	15.47	29	16178	7876	34932848
Hyperlipidaemia	34.51	15.47	38	16169	14491	34926233
Superior mesenteric artery syndrome	33.92	15.47	8	16199	84	34940640
Lipohypertrophy	33.65	15.47	10	16197	268	34940456
Anal cancer stage 0	32.85	15.47	6	16201	14	34940710
Congenital anomaly	32.83	15.47	15	16192	1378	34939346
Coarctation of the aorta	32.25	15.47	11	16196	464	34940260
Neuropsychiatric symptoms	32.10	15.47	13	16194	889	34939835
HIV lipodystrophy	31.51	15.47	6	16201	19	34940705
Congenital mitral valve incompetence	30.09	15.47	8	16199	141	34940583
Heart disease congenital	29.75	15.47	14	16193	1376	34939348
Drug level decreased	28.79	15.47	26	16181	7820	34932904
HIV associated nephropathy	27.75	15.47	9	16198	324	34940400
Acquired gene mutation	27.02	15.47	13	16194	1342	34939382
Foetal growth restriction	26.58	15.47	19	16188	4098	34936626
Foetal death	26.48	15.47	8	16199	227	34940497
Hyperphagia	26.42	15.47	13	16194	1410	34939314
Cushingoid	25.95	15.47	16	16191	2698	34938026
Foetal chromosome abnormality	25.76	15.47	5	16202	18	34940706
Blood pressure increased	25.38	15.47	5	16202	88097	34852627
Pneumocystis jirovecii pneumonia	25.32	15.47	38	16169	19672	34921052
Glycosuria	25.07	15.47	12	16195	1225	34939499
Acute kidney injury	25.03	15.47	233	15974	304755	34635969
Immune reconstitution inflammatory syndrome associated tuberculosis	24.94	15.47	9	16198	449	34940275
Anal cancer	24.84	15.47	9	16198	454	34940270
Conductive deafness	24.30	15.47	8	16199	302	34940422
Urinary tract inflammation	24.25	15.47	7	16200	169	34940555
Cytomegalovirus chorioretinitis	24.18	15.47	17	16190	3572	34937152
Constipation	24.17	15.47	17	16190	136965	34803759
Disease progression	24.04	15.47	10	16197	108067	34832657
Acquired immunodeficiency syndrome	23.86	15.47	9	16198	509	34940215
Hepatic cancer	23.85	15.47	24	16183	8251	34932473
Leishmaniasis	23.76	15.47	8	16199	324	34940400
Small for dates baby	22.81	15.47	17	16190	3910	34936814
Pneumonia	22.71	15.47	89	16118	362538	34578186
Hypercholesterolaemia	22.71	15.47	24	16183	8738	34931986
Maternal drugs affecting foetus	22.66	15.47	17	16190	3948	34936776
Ergot poisoning	22.64	15.47	5	16202	38	34940686
Anogenital warts	22.62	15.47	9	16198	588	34940136
Pulmonary sequestration	22.42	15.47	5	16202	40	34940684
Congenital renal disorder	22.34	15.47	6	16201	110	34940614
Drug abuse	22.31	15.47	9	16198	99087	34841637
CD4 lymphocytes abnormal	22.20	15.47	5	16202	42	34940682
Blood HIV RNA	22.00	15.47	4	16203	9	34940715
Acute myocardial infarction	21.36	15.47	64	16143	53655	34887069
HIV infection	21.25	15.47	11	16196	1328	34939396
Cranial nerve palsies multiple	20.99	15.47	5	16202	55	34940669
Adrenal insufficiency	20.84	15.47	29	16178	14018	34926706
Peripheral swelling	20.72	15.47	5	16202	76536	34864188
Post transplant distal limb syndrome	20.69	15.47	7	16200	288	34940436
Product use complaint	20.55	15.47	11	16196	1421	34939303
Pain	20.43	15.47	40	16167	204635	34736089
Cortisol decreased	20.04	15.47	10	16197	1117	34939607
Hepatitis B DNA assay positive	19.88	15.47	5	16202	70	34940654
Treatment failure	19.87	15.47	57	16150	46640	34894084
Malignant neoplasm progression	19.82	15.47	8	16199	88038	34852686
Eosinophilic pustular folliculitis	19.68	15.47	5	16202	73	34940651
Spinal compression fracture	19.35	15.47	20	16187	7096	34933628
Blood creatine phosphokinase increased	19.32	15.47	55	16152	44802	34895922
Congenital vesicoureteric reflux	19.23	15.47	4	16203	22	34940702
Heart transplant rejection	19.21	15.47	10	16197	1221	34939503
Atypical mycobacterial infection	19.13	15.47	9	16198	884	34939840
Beta 2 microglobulin urine increased	18.92	15.47	5	16202	86	34940638
Fanconi syndrome	18.67	15.47	11	16196	1709	34939015
Proteinuria	18.55	15.47	32	16175	18610	34922114
Product residue present	18.48	15.47	13	16194	2733	34937991
Liver function test abnormal	18.45	15.47	43	16164	31031	34909693
Induration	18.38	15.47	9	16198	966	34939758
Testicular mass	18.26	15.47	5	16202	99	34940625
Oesophageal ulcer	18.23	15.47	14	16193	3367	34937357
Renal tubular dysfunction	18.08	15.47	7	16200	425	34940299
Renal colic	17.99	15.47	11	16196	1828	34938896
ECG signs of ventricular hypertrophy	17.95	15.47	3	16204	3	34940721
17-hydroxyprogesterone increased	17.95	15.47	3	16204	3	34940721
Mycobacterium avium complex immune restoration disease	17.62	15.47	4	16203	35	34940689
Myelocytosis	17.42	15.47	4	16203	37	34940687
Osteoporotic fracture	17.39	15.47	9	16198	1086	34939638
Hyperuricaemia	17.33	15.47	20	16187	8023	34932701
Amyotrophy	17.27	15.47	7	16200	480	34940244
Coccidioidomycosis	17.26	15.47	8	16199	759	34939965
Vitamin D deficiency	16.94	15.47	18	16189	6590	34934134
Hypotension	16.83	15.47	50	16157	221599	34719125
Hypophosphataemia	16.71	15.47	23	16184	11003	34929721
Skin test negative	16.71	15.47	4	16203	45	34940679
Hyperphosphatasaemia	16.55	15.47	4	16203	47	34940677
Retinitis pigmentosa	16.40	15.47	4	16203	49	34940675
Viraemia	16.35	15.47	9	16198	1229	34939495
Fatigue	16.27	15.47	103	16104	370550	34570174
Meralgia paraesthetica	16.13	15.47	5	16202	155	34940569
Embolism	16.09	15.47	19	16188	7810	34932914
Joint swelling	16.03	15.47	4	16203	59886	34880838
Stevens-Johnson syndrome	15.99	15.47	30	16177	18609	34922115
Hepatic cytolysis	15.91	15.47	26	16181	14470	34926254
Chest discomfort	15.90	15.47	3	16204	54527	34886197
Lymphoma	15.90	15.47	24	16183	12483	34928241
VIIIth nerve injury	15.88	15.47	3	16204	9	34940715
Hypo HDL cholesterolaemia	15.88	15.47	3	16204	9	34940715
Vth nerve injury	15.88	15.47	3	16204	9	34940715
Progressive multifocal leukoencephalopathy	15.76	15.47	21	16186	9743	34930981
Liver disorder	15.74	15.47	42	16165	32955	34907769
Duodenal atresia	15.64	15.47	3	16204	10	34940714
Congenital ureteric anomaly	15.58	15.47	4	16203	61	34940663
Hypermetabolism	15.58	15.47	5	16202	174	34940550
Relapsing fever	15.55	15.47	5	16202	175	34940549
Viral load	15.52	15.47	4	16203	62	34940662

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
Immune reconstitution inflammatory syndrome	620.99	16.19	199	18823	13642	79711724
Drug interaction	572.02	16.19	592	18430	414591	79310775
Virologic failure	563.29	16.19	142	18880	4049	79721317
Abortion spontaneous	538.63	16.19	218	18804	29289	79696077
Lipodystrophy acquired	534.28	16.19	137	18885	4188	79721178
Exposure during pregnancy	510.40	16.19	311	18711	100821	79624545
Viral mutation identified	407.87	16.19	108	18914	3750	79721616
Mitochondrial toxicity	376.57	16.19	97	18925	3017	79722349
Progressive external ophthalmoplegia	350.84	16.19	79	18943	1366	79724000
Pathogen resistance	282.45	16.19	112	18910	14230	79711136
Blood HIV RNA increased	251.54	16.19	63	18959	1745	79723621
Eyelid ptosis	248.46	16.19	95	18927	10949	79714417
Viral load increased	230.03	16.19	65	18957	2883	79722483
Drug resistance	207.88	16.19	128	18894	42085	79683281
Maternal exposure during pregnancy	198.13	16.19	201	18821	136337	79589029
Treatment noncompliance	197.07	16.19	134	18888	52134	79673232
Genotype drug resistance test positive	184.06	16.19	46	18976	1262	79724104
Diplopia	148.46	16.19	95	18927	33371	79691995
Renal tubular disorder	143.02	16.19	55	18967	6431	79718935
Premature labour	142.73	16.19	59	18963	8331	79717035
Abortion induced	141.62	16.19	56	18966	7053	79718313
HIV-associated neurocognitive disorder	140.60	16.19	29	18993	323	79725043
CD4 lymphocytes decreased	139.39	16.19	43	18979	2591	79722775
Osteoporosis	126.13	16.19	104	18918	54008	79671358
Live birth	121.66	16.19	68	18954	18676	79706690
Foetal exposure during pregnancy	109.73	16.19	44	18978	5746	79719620
Premature delivery	107.51	16.19	68	18954	23399	79701967
CSF HIV escape syndrome	106.52	16.19	23	18999	324	79725042
Premature rupture of membranes	106.05	16.19	39	18983	4030	79721336
Nephropathy toxic	100.68	16.19	62	18960	20357	79705009
Adrenal suppression	96.39	16.19	28	18994	1371	79723995
Syphilis	95.81	16.19	23	18999	531	79724835
Hepatocellular injury	93.61	16.19	83	18939	47510	79677856
Dyslipidaemia	88.81	16.19	47	18975	11586	79713780
Brain stem stroke	80.14	16.19	21	19001	698	79724668
Stillbirth	78.23	16.19	31	18991	3924	79721442
Foetal death	77.42	16.19	38	18984	8006	79717360
Acute kidney injury	77.00	16.19	285	18737	519119	79206247
Hypertriglyceridaemia	76.68	16.19	44	18978	12696	79712670
Drug reaction with eosinophilia and systemic symptoms	74.36	16.19	84	18938	64160	79661206
Cushingoid	74.08	16.19	39	18983	9513	79715853
Ophthalmoplegia	72.54	16.19	27	18995	2885	79722481
Fanconi syndrome acquired	70.87	16.19	26	18996	2668	79722698
Osteonecrosis	68.77	16.19	58	18964	31037	79694329
Lipohypertrophy	66.74	16.19	19	19003	865	79724501
Rash maculo-papular	66.05	16.19	74	18948	56004	79669362
Pain	62.72	16.19	46	18976	703756	79021610
Renal impairment	59.30	16.19	122	18900	157661	79567705
Hepatitis cholestatic	58.15	16.19	38	18984	13814	79711552
Cholestasis of pregnancy	55.89	16.19	17	19005	976	79724390
Genital herpes	54.40	16.19	20	19002	2064	79723302
Joint swelling	53.58	16.19	4	19018	288642	79436724
Mycobacterium avium complex infection	51.16	16.19	24	18998	4576	79720790
Dyspnoea	50.74	16.19	79	18943	856946	78868420
Nephrolithiasis	50.62	16.19	63	18959	53228	79672138
Gene mutation	49.47	16.19	20	19002	2666	79722700
Caesarean section	49.25	16.19	33	18989	12502	79712864
Premature baby	49.19	16.19	22	19000	3758	79721608
Hyperadrenocorticism	47.47	16.19	12	19010	345	79725021
Anogenital dysplasia	47.27	16.19	10	19012	127	79725239
Psychomotor retardation	47.24	16.19	25	18997	6159	79719207
Gastroschisis	46.49	16.19	8	19014	29	79725337
Hepatitis B DNA increased	46.08	16.19	14	19008	801	79724565
Adrenal insufficiency	45.02	16.19	44	18978	28443	79696923
Hepatitis C	43.54	16.19	30	18992	11895	79713471
Anal cancer stage 0	42.48	16.19	7	19015	18	79725348
Renal tubular dysfunction	42.45	16.19	13	19009	764	79724602
Infusion related reaction	40.51	16.19	4	19018	230233	79495133
Multiple-drug resistance	39.03	16.19	25	18997	8783	79716583
Renal colic	38.54	16.19	17	19005	2810	79722556
Genital herpes simplex	37.05	16.19	10	19012	373	79724993
Endometritis decidual	36.54	16.19	6	19016	15	79725351
HIV lipodystrophy	36.54	16.19	6	19016	15	79725351
Nasopharyngitis	36.44	16.19	8	19014	253873	79471493
Alopecia	35.94	16.19	6	19016	231349	79494017
Trisomy 21	35.70	16.19	7	19015	59	79725307
Central obesity	35.52	16.19	14	19008	1747	79723619
Hepatitis B	35.32	16.19	23	18999	8309	79717057
Skin striae	34.57	16.19	14	19008	1874	79723492
Arthralgia	34.44	16.19	52	18970	571751	79153615
Foetal growth abnormality	34.20	16.19	6	19016	25	79725341
HIV associated nephropathy	33.55	16.19	9	19013	328	79725038
Proteinuria	33.41	16.19	40	18982	32462	79692904
Superior mesenteric artery syndrome	33.35	16.19	8	19014	184	79725182
Total bile acids increased	33.01	16.19	7	19015	90	79725276
Generalised anxiety disorder	32.52	16.19	14	19008	2183	79723183
Complication of pregnancy	32.45	16.19	9	19013	372	79724994
Oesophageal atresia	32.33	16.19	7	19015	100	79725266
Acute myocardial infarction	31.82	16.19	62	18960	76974	79648392
Liver function test abnormal	31.79	16.19	56	18966	64419	79660947
Neuropsychiatric symptoms	31.19	16.19	12	19010	1403	79723963
Fatigue	30.90	16.19	116	18906	929611	78795755
Peripheral swelling	30.60	16.19	13	19009	269604	79455762
Eosinophilia	30.00	16.19	45	18977	45300	79680066
Dermatitis exfoliative	29.88	16.19	23	18999	10806	79714560
Immune reconstitution inflammatory syndrome associated tuberculosis	29.35	16.19	10	19012	826	79724540
Fanconi syndrome	29.01	16.19	14	19008	2842	79722524
Pneumocystis jirovecii pneumonia	28.60	16.19	37	18985	32471	79692895
Congenital intestinal malformation	28.47	16.19	5	19017	21	79725345
Therapeutic product effect decreased	28.42	16.19	3	19019	163860	79561506
Cholestasis	27.97	16.19	47	18975	52062	79673304
Blood HIV RNA	27.92	16.19	5	19017	24	79725342
Renal tubular necrosis	27.70	16.19	32	18990	25007	79700359
Diabetes mellitus	27.54	16.19	59	18963	78331	79647035
Pulmonary sequestration	27.28	16.19	5	19017	28	79725338
Ventricular hypoplasia	26.59	16.19	4	19018	4	79725362
Conductive deafness	26.56	16.19	7	19015	238	79725128
Foetal growth restriction	26.52	16.19	12	19010	2107	79723259
Teratogenicity	26.39	16.19	7	19015	244	79725122
Vitamin D deficiency	26.28	16.19	24	18998	14255	79711111
Glycosuria	26.15	16.19	12	19010	2176	79723190
Urinary tract inflammation	26.15	16.19	7	19015	253	79725113
Eosinophilic pustular folliculitis	26.00	16.19	6	19016	116	79725250
Blood pressure increased	25.95	16.19	9	19013	211351	79514015
Constipation	25.79	16.19	18	19004	283032	79442334
Gestational diabetes	25.77	16.19	17	19005	6276	79719090
Polyhydramnios	25.59	16.19	11	19011	1709	79723657
Amniotic cavity infection	25.58	16.19	9	19013	818	79724548
Glucocorticoids increased	25.44	16.19	6	19016	128	79725238
Infection	25.35	16.19	13	19009	241699	79483667
CSF test abnormal	25.12	16.19	8	19014	535	79724831
Atrial fibrillation	25.04	16.19	8	19014	197878	79527488
Spina bifida	24.73	16.19	6	19016	145	79725221
Sinusitis	24.57	16.19	8	19014	195493	79529873
Immunosuppressant drug level increased	24.53	16.19	19	19003	9008	79716358
Anogenital warts	24.51	16.19	9	19013	925	79724441
CD4 lymphocytes abnormal	24.46	16.19	5	19017	53	79725313
Abdominal discomfort	24.11	16.19	15	19007	250712	79474654
Hypoplastic left heart syndrome	24.08	16.19	4	19018	11	79725355
Pre-eclampsia	24.04	16.19	17	19005	7024	79718342
Potassium wasting nephropathy	24.02	16.19	6	19016	164	79725202
New onset diabetes after transplantation	24.02	16.19	6	19016	164	79725202
Hepatic cancer	24.02	16.19	20	19002	10509	79714857
White matter lesion	23.88	16.19	11	19011	2011	79723355
Fall	23.38	16.19	51	18971	487578	79237788
Coarctation of the aorta	23.25	16.19	5	19017	69	79725297
Cortisol decreased	23.13	16.19	11	19011	2161	79723205
Testicular mass	23.05	16.19	5	19017	72	79725294
Hypercholesterolaemia	23.05	16.19	28	18994	23067	79702299
Drug level increased	22.95	16.19	37	18985	39614	79685752
Cytomegalovirus chorioretinitis	22.89	16.19	15	19007	5475	79719891
Abortion threatened	22.75	16.19	7	19015	418	79724948
Blood creatine phosphokinase increased	22.36	16.19	49	18973	66041	79659325
Pain in extremity	22.06	16.19	33	18989	364505	79360861
Labelled drug-drug interaction medication error	22.05	16.19	30	18992	27620	79697746
Hyperlipidaemia	21.87	16.19	29	18993	26064	79699302
Pancreatitis acute	21.81	16.19	41	18981	49563	79675803
Face oedema	21.65	16.19	30	18992	28106	79697260
Prurigo	21.18	16.19	9	19013	1360	79724006
Cranial nerve palsies multiple	20.84	16.19	5	19017	115	79725251
Atrioventricular septal defect	20.80	16.19	5	19017	116	79725250
Dizziness	20.64	16.19	61	18961	526380	79198986
Cushing's syndrome	20.38	16.19	8	19014	987	79724379
Post transplant distal limb syndrome	20.37	16.19	7	19015	593	79724773
Benign prostatic hyperplasia	20.36	16.19	19	19003	11593	79713773
Hyperbilirubinaemia	20.16	16.19	27	18995	24491	79700875
Hyperuricaemia	20.11	16.19	19	19003	11780	79713586
Discomfort	20.08	16.19	3	19019	125614	79599752
ECG signs of ventricular hypertrophy	19.95	16.19	3	19019	3	79725363
Acquired gene mutation	19.86	16.19	10	19012	2223	79723143
Secondary adrenocortical insufficiency	19.73	16.19	11	19011	3003	79722363
Hypophosphataemia	19.64	16.19	24	18998	19889	79705477
Swelling	19.44	16.19	14	19008	216697	79508669
HIV infection	19.42	16.19	8	19014	1119	79724247
Feeling abnormal	19.16	16.19	7	19015	159192	79566174
Musculoskeletal stiffness	18.97	16.19	9	19013	174999	79550367
Back pain	18.92	16.19	27	18995	304153	79421213
Mitochondrial cytopathy	18.80	16.19	6	19016	404	79724962
Hyperproteinaemia	18.78	16.19	5	19017	177	79725189
Blood triglycerides increased	18.59	16.19	24	18998	21016	79704350
Stomatitis	18.45	16.19	6	19016	146751	79578615
Wheezing	18.16	16.19	3	19019	116661	79608705
Rhabdomyolysis	18.13	16.19	60	18962	103071	79622295
Drug-induced liver injury	17.98	16.19	45	18977	66072	79659294
Hypo HDL cholesterolaemia	17.87	16.19	3	19019	9	79725357
Vth nerve injury	17.87	16.19	3	19019	9	79725357
Disease progression	17.76	16.19	11	19011	184351	79541015
Hepatitis acute	17.42	16.19	20	19002	15522	79709844
Progressive multifocal leukoencephalopathy	17.42	16.19	23	18999	20577	79704789
Embolism	17.40	16.19	19	19003	13963	79711403
Mobility decreased	17.22	16.19	4	19018	122171	79603195
Arteriovenous graft site pseudoaneurysm	17.20	16.19	3	19019	12	79725354
Drug intolerance	16.87	16.19	23	18999	264096	79461270
Pneumonia	16.70	16.19	91	18931	660155	79065211
Hepatic cytolysis	16.62	16.19	26	18996	27125	79698241
Renal failure	16.62	16.19	93	18929	200875	79524491
Encephalitis	16.56	16.19	19	19003	14741	79710625
Heart disease congenital	16.44	16.19	6	19016	606	79724760
Amyotrophy	16.37	16.19	6	19016	614	79724752
Coagulation factor V level decreased	16.26	16.19	6	19016	625	79724741
Acute haemorrhagic conjunctivitis	16.19	16.19	3	19019	18	79725348

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	J05AE10	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Protease inhibitors
ATC	J05AR14	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR22	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR26	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
FDA MoA	N0000000246	HIV Protease Inhibitors
MeSH PA	D019380	Anti-HIV Agents
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D044966	Anti-Retroviral Agents
MeSH PA	D000998	Antiviral Agents
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D017320	HIV Protease Inhibitors
MeSH PA	D011480	Protease Inhibitors
MeSH PA	D000084762	Viral Protease Inhibitors
FDA EPC	N0000175889	Protease Inhibitor
FDA MoA	N0000182137	Cytochrome P450 2D6 Inhibitors
FDA MoA	N0000190114	Cytochrome P450 3A Inhibitors
CHEBI has role	CHEBI:35660	HIV protease inhibitors
CHEBI has role	CHEBI:36044	antiviral drugs

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

Disease	Relation	SNOMED_ID	DOID
Human immunodeficiency virus infection	indication	86406008	DOID:526
Coronavirus infection	off-label use	186747009
Hypercholesterolemia	contraindication	13644009
Cirrhosis of liver	contraindication	19943007	DOID:5082
Hereditary factor VIII deficiency disease	contraindication	28293008	DOID:12134
Hereditary factor IX deficiency disease	contraindication	41788008	DOID:12259
Hepatic failure	contraindication	59927004
Chronic type B viral hepatitis	contraindication	61977001
Diabetes mellitus	contraindication	73211009	DOID:9351
Hyperglycemia	contraindication	80394007	DOID:4195
Chronic hepatitis C	contraindication	128302006
Liver function tests abnormal	contraindication	166603001
Disease of liver	contraindication	235856003	DOID:409
Hypertriglyceridemia	contraindication	302870006
Breastfeeding (mother)	contraindication	413712001

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	13.67	acidic
pKa2	1.64	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
150MG;800MG	PREZCOBIX	JANSSEN PRODS	N205395	Jan. 29, 2015	RX	TABLET	ORAL	8148374	Sept. 3, 2029	TREATMENT OF HIV INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40KG USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE
150MG;800MG	PREZCOBIX	JANSSEN PRODS	N205395	Jan. 29, 2015	RX	TABLET	ORAL	8148374	Sept. 3, 2029	TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE
150MG;800MG;200MG;EQ 10MG BASE	SYMTUZA	JANSSEN PRODS	N210455	July 17, 2018	RX	TABLET	ORAL	8148374	Sept. 3, 2029	TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE IN ADULTS WHO ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
150MG;800MG;200MG;EQ 10MG BASE	SYMTUZA	JANSSEN PRODS	N210455	July 17, 2018	RX	TABLET	ORAL	8148374	Sept. 3, 2029	TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY
150MG;800MG;200MG;EQ 10MG BASE	SYMTUZA	JANSSEN PRODS	N210455	July 17, 2018	RX	TABLET	ORAL	8148374	Sept. 3, 2029	TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CY P450 MONOXYGENASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40KG WHO ARE VIROLOGICALLY SUPPRESSED ON A STABLE ARV REGIMEN FOR AT LEAST 6 MONTHS
150MG;800MG;200MG;EQ 10MG BASE	SYMTUZA	JANSSEN PRODS	N210455	July 17, 2018	RX	TABLET	ORAL	8148374	Sept. 3, 2029	TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CY P450 MONOXYGENASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40KG WHO HAVE NO PRIOR ARV TREATMENT HISTORY
150MG;800MG;200MG;EQ 10MG BASE	SYMTUZA	JANSSEN PRODS	N210455	July 17, 2018	RX	TABLET	ORAL	8148374	Sept. 3, 2029	TX OF HIV1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CY P450 MONOXYGENASE IN ADULTS & PEDIATRIC PATIENTS AT LEAST 40KG HAVING NO PRIOR ARV TX HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ARV REGIMEN FOR AT LEAST 6 MO
150MG;800MG;200MG;EQ 10MG BASE	SYMTUZA	JANSSEN PRODS	N210455	July 17, 2018	RX	TABLET	ORAL	8148374	Sept. 3, 2029	TX OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENATES IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TX HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
150MG;800MG;200MG;EQ 10MG BASE	SYMTUZA	JANSSEN PRODS	N210455	July 17, 2018	RX	TABLET	ORAL	8754065	Aug. 15, 2032	TREATMENT OF HIV-1 INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40 KG WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
150MG;800MG;200MG;EQ 10MG BASE	SYMTUZA	JANSSEN PRODS	N210455	July 17, 2018	RX	TABLET	ORAL	8754065	Aug. 15, 2032	TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
150MG;800MG;200MG;EQ 10MG BASE	SYMTUZA	JANSSEN PRODS	N210455	July 17, 2018	RX	TABLET	ORAL	9296769	Aug. 15, 2032	TREATMENT OF HIV-1 INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40 KG WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
150MG;800MG;200MG;EQ 10MG BASE	SYMTUZA	JANSSEN PRODS	N210455	July 17, 2018	RX	TABLET	ORAL	9296769	Aug. 15, 2032	TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
150MG;800MG;200MG;EQ 10MG BASE	SYMTUZA	JANSSEN PRODS	N210455	July 17, 2018	RX	TABLET	ORAL	10786518	July 19, 2038	TREATMENT OF HIV-1 INFECTION IN ADULT OR PEDIATRIC PATIENTS (>=40 KG) WITH <50 COPIES/ML HIV-1 RNA AFTER >= 6 MONTHS ON PRIOR ANTIRETROVIRAL REGIMEN AND NO KNOWN DARUNAVIR OR TENOFOVIR RESISTANCE-ASSOCIATED SUBSTITUTIONS

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
800MG	DARUNAVIR	LUPIN LTD	A202073	Sept. 29, 2022	RX	TABLET	ORAL	Nov. 28, 2023	PATENT CHALLENGE

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN		IC50	5.18	CHEMBL
Pol polyprotein	Enzyme		Q72874_9HIV1	INHIBITOR	Ki	10.85	CHEMBL	CHEMBL
Gag-Pol polyprotein	Polyprotein		POL_HV1BR		Ki	9.66	WOMBAT-PK
Protease	Enzyme		Q9YQ12_9HIV1		IC50	10.21	CHEMBL
Protease	Unclassified		O90781_9PLVG		Ki	10.96	CHEMBL
Protease	Unclassified		Q9YQ30_9PLVG		Ki	10.82	CHEMBL

External reference:

ID	Source
4025441	VUID
N0000179778	NUI
D03656	KEGG_DRUG
635728-49-3	SECONDARY_CAS_RN
4025441	VANDF
4025493	VANDF
C1435444	UMLSCUI
CHEBI:367163	CHEBI
017	PDB_CHEM_ID
CHEMBL1323	ChEMBL_ID
CHEMBL1201127	ChEMBL_ID
D000069454	MESH_DESCRIPTOR_UI
DB01264	DRUGBANK_ID
11243	IUPHAR_LIGAND_ID
8305	INN_ID
YO603Y8113	UNII
213039	PUBCHEM_CID
460132	RXNORM
21619	MMSL
310017	MMSL
83005	MMSL
d05825	MMSL
011599	NDDF
011600	NDDF
423888002	SNOMEDCT_US
424096001	SNOMEDCT_US
428318002	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
PREZCOBIX	HUMAN PRESCRIPTION DRUG LABEL	2	50090-1723	TABLET, FILM COATED	800 mg	ORAL	NDA	29 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	53808-0672	TABLET, FILM COATED	400 mg	ORAL	NDA	31 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	53808-0773	TABLET, FILM COATED	600 mg	ORAL	NDA	31 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	54868-5969	TABLET, FILM COATED	400 mg	ORAL	NDA	31 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	54868-6369	TABLET, FILM COATED	600 mg	ORAL	NDA	31 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-562	TABLET, FILM COATED	600 mg	ORAL	NDA	31 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-562	TABLET, FILM COATED	600 mg	ORAL	NDA	31 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-562	TABLET, FILM COATED	600 mg	ORAL	NDA	31 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-562	TABLET, FILM COATED	600 mg	ORAL	NDA	31 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-563	TABLET, FILM COATED	75 mg	ORAL	NDA	31 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-563	TABLET, FILM COATED	75 mg	ORAL	NDA	31 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-563	TABLET, FILM COATED	75 mg	ORAL	NDA	31 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-563	TABLET, FILM COATED	75 mg	ORAL	NDA	31 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-564	TABLET, FILM COATED	150 mg	ORAL	NDA	31 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-564	TABLET, FILM COATED	150 mg	ORAL	NDA	31 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-564	TABLET, FILM COATED	150 mg	ORAL	NDA	31 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-564	TABLET, FILM COATED	150 mg	ORAL	NDA	31 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-565	SUSPENSION	100 mg	ORAL	NDA	31 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-565	SUSPENSION	100 mg	ORAL	NDA	31 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-565	SUSPENSION	100 mg	ORAL	NDA	31 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-565	SUSPENSION	100 mg	ORAL	NDA	31 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-566	TABLET, FILM COATED	800 mg	ORAL	NDA	31 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-566	TABLET, FILM COATED	800 mg	ORAL	NDA	31 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-566	TABLET, FILM COATED	800 mg	ORAL	NDA	31 sections
PREZISTA	HUMAN PRESCRIPTION DRUG LABEL	1	59676-566	TABLET, FILM COATED	800 mg	ORAL	NDA	31 sections
PREZCOBIX	HUMAN PRESCRIPTION DRUG LABEL	2	59676-575	TABLET, FILM COATED	800 mg	ORAL	NDA	30 sections
PREZCOBIX	HUMAN PRESCRIPTION DRUG LABEL	2	59676-575	TABLET, FILM COATED	800 mg	ORAL	NDA	30 sections
PREZCOBIX	HUMAN PRESCRIPTION DRUG LABEL	2	59676-575	TABLET, FILM COATED	800 mg	ORAL	NDA	30 sections
PREZCOBIX	HUMAN PRESCRIPTION DRUG LABEL	2	59676-575	TABLET, FILM COATED	800 mg	ORAL	NDA	30 sections
Symtuza	HUMAN PRESCRIPTION DRUG LABEL	4	59676-800	TABLET, FILM COATED	800 mg	ORAL	NDA	34 sections