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

Stem definition	Drug id	CAS RN
aromatic ring -CH(-OH)-CH2-NH-R	2464	3930-20-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: sotalol DL-Sotalol sotalol hydrochloride sotylize sotalol HCl	An adrenergic beta-antagonist that is used in the treatment of life-threatening arrhythmias. Molecular weight: 272.36 Formula: C12H20N2O3S CLOGP: 0.23 LIPINSKI: 0 HAC: 5 HDO: 3 TPSA: 78.43 ALOGS: -2.54 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

sotalol
DL-Sotalol
sotalol hydrochloride
sotylize
sotalol HCl

An adrenergic beta-antagonist that is used in the treatment of life-threatening arrhythmias.

Molecular weight: 272.36
Formula: C12H20N2O3S
CLOGP: 0.23
LIPINSKI: 0
HAC: 5
HDO: 3
TPSA: 78.43
ALOGS: -2.54
ROTB: 5

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.16	g	O
0.16	g	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	137 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	85 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	19.57 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	95 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	1.30 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	2 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.62 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	6.30 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Oct. 30, 1992	FDA	COVIS PHARMA SARL

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
Torsade de pointes	307.65	14.76	115	14166	13236	63461505
Atrial fibrillation	231.50	14.76	199	14082	116437	63358304
Electrocardiogram QT prolonged	209.65	14.76	143	14138	59387	63415354
Bradycardia	121.41	14.76	113	14168	73114	63401627
Ventricular tachycardia	118.66	14.76	67	14214	19912	63454829
Drug interaction	110.10	14.76	190	14091	228941	63245800
Atrial tachycardia	95.71	14.76	36	14245	4204	63470537
International normalised ratio increased	83.46	14.76	75	14206	46350	63428391
Arrhythmia	71.29	14.76	63	14218	38077	63436664
Hyponatraemia	63.32	14.76	100	14181	111800	63362941
Hypotension	63.04	14.76	168	14113	272436	63202305
Sinus bradycardia	58.49	14.76	38	14243	14513	63460228
Palpitations	54.66	14.76	94	14187	112676	63362065
Cerebral haematoma	54.29	14.76	23	14258	3660	63471081
Urinary incontinence	50.31	14.76	48	14233	31966	63442775
Ischaemic stroke	49.03	14.76	37	14244	17920	63456821
Hyperkalaemia	47.89	14.76	60	14221	54143	63420598
Subarachnoid haemorrhage	47.11	14.76	33	14248	14250	63460491
Cardiospasm	45.99	14.76	17	14264	1890	63472851
Palmoplantar keratoderma	45.15	14.76	17	14264	1990	63472751
Cardio-respiratory arrest	44.62	14.76	61	14220	59898	63414843
Hepatocellular injury	42.92	14.76	41	14240	27340	63447401
Carotid artery occlusion	42.86	14.76	21	14260	4673	63470068
Erythromelalgia	41.37	14.76	9	14272	140	63474601
Syncope	40.90	14.76	85	14196	117300	63357441
Cardiac arrest	40.77	14.76	74	14207	92471	63382270
Pruritus genital	40.54	14.76	17	14264	2637	63472104
Sleep terror	40.38	14.76	17	14264	2663	63472078
Transient ischaemic attack	38.58	14.76	45	14236	37708	63437033
Tension headache	38.01	14.76	20	14261	5166	63469575
Cardiac disorder	36.76	14.76	51	14230	50765	63423976
Atrioventricular block	35.81	14.76	22	14259	7625	63467116
Presyncope	35.08	14.76	37	14244	27748	63446993
Atrial flutter	33.22	14.76	23	14258	9749	63464992
Asthenia	33.20	14.76	172	14109	383432	63091309
Inappropriate antidiuretic hormone secretion	31.83	14.76	27	14254	15435	63459306
Ventricular fibrillation	31.40	14.76	24	14257	11843	63462898
Apallic syndrome	31.38	14.76	10	14271	711	63474030
Systemic lupus erythematosus	30.85	14.76	5	14276	208913	63265828
Joint swelling	30.44	14.76	18	14263	327648	63147093
Anosmia	30.26	14.76	19	14262	6841	63467900
Drug intolerance	30.05	14.76	16	14265	308645	63166096
Acute kidney injury	30.01	14.76	128	14153	263287	63211454
Bundle branch block left	29.76	14.76	19	14262	7040	63467701
Localised oedema	29.15	14.76	17	14264	5361	63469380
Malaise	29.01	14.76	176	14105	415778	63058963
Ventricular arrhythmia	28.73	14.76	15	14266	3813	63470928
Contraindicated product administered	28.40	14.76	7	14274	217641	63257100
Long QT syndrome	27.95	14.76	14	14267	3265	63471476
Immunisation	26.45	14.76	10	14271	1183	63473558
Wound	26.25	14.76	3	14278	163260	63311481
Arthropathy	26.24	14.76	10	14271	234782	63239959
Subdural haematoma	25.44	14.76	23	14258	14305	63460436
Tachycardia	25.41	14.76	71	14210	118085	63356656
Melaena	24.27	14.76	32	14249	30333	63444408
Atrial rupture	23.96	14.76	5	14276	63	63474678
Gastrointestinal haemorrhage	23.95	14.76	55	14226	81121	63393620
Cardioactive drug level increased	23.61	14.76	11	14270	2189	63472552
Nasal mucosal erosion	23.54	14.76	5	14276	69	63474672
Rheumatoid arthritis	23.48	14.76	14	14267	253805	63220936
Sinus node dysfunction	23.27	14.76	14	14267	4671	63470070
Organising pneumonia	23	14.76	15	14266	5761	63468980
Pain	22.65	14.76	88	14193	740540	62734201
Haematoma	22.32	14.76	33	14248	34787	63439954
Hypersensitivity	22.08	14.76	20	14261	292665	63182076
Infusion related reaction	22.07	14.76	14	14267	245507	63229234
Heart rate increased	21.63	14.76	58	14223	94180	63380561
Cardiac failure congestive	21.32	14.76	57	14224	92376	63382365
Cardiac ablation	20.98	14.76	9	14272	1476	63473265
Infection	20.69	14.76	13	14268	229160	63245581
Electrocardiogram QRS complex prolonged	20.24	14.76	14	14267	5924	63468817
Product use issue	19.24	14.76	13	14268	220507	63254234
Anaemia macrocytic	18.93	14.76	11	14270	3443	63471298
Loss of consciousness	18.88	14.76	64	14217	118057	63356684
Facial pain	18.84	14.76	17	14264	10544	63464197
Eye pruritus	18.64	14.76	22	14259	18649	63456092
Hepatic cytolysis	18.53	14.76	20	14261	15387	63459354
Hypoglycaemia	18.05	14.76	41	14240	60024	63414717
Noninfective gingivitis	17.98	14.76	8	14273	1433	63473308
Mobility decreased	17.65	14.76	3	14278	121156	63353585
Pain of skin	17.44	14.76	17	14264	11617	63463124
Vasculitis	17.43	14.76	21	14260	18188	63456553
Fall	17.42	14.76	149	14132	392185	63082556
Musculoskeletal stiffness	17.33	14.76	10	14271	184608	63290133
Swelling	17.23	14.76	22	14259	275356	63199385
Disturbance in attention	16.12	14.76	30	14251	38159	63436582
Therapeutic product effect decreased	16.05	14.76	12	14269	193175	63281566
Haemorrhagic stroke	15.95	14.76	12	14269	5780	63468961
Diplopia	15.95	14.76	23	14258	23705	63451036
Discomfort	15.80	14.76	9	14272	167365	63307376
Blood glucose increased	15.76	14.76	48	14233	83708	63391033
Skin test positive	15.74	14.76	6	14275	726	63474015
Optic nerve infarction	15.61	14.76	3	14278	24	63474717
Cerebral congestion	15.40	14.76	3	14278	26	63474715
Blood loss anaemia	15.10	14.76	14	14267	8987	63465754
Resting tremor	15.06	14.76	6	14275	817	63473924

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
Atrial fibrillation	196.33	14.63	231	12411	122162	34822127
Bradycardia	137.02	14.63	152	12490	75266	34869023
Ventricular tachycardia	105.76	14.63	83	12559	26496	34917793
Electrocardiogram QT prolonged	102.27	14.63	98	12544	40854	34903435
Torsade de pointes	91.61	14.63	47	12595	7162	34937127
Atrial flutter	60.55	14.63	48	12594	15526	34928763
Palpitations	50.30	14.63	67	12575	39919	34904370
Cardiogenic shock	48.83	14.63	54	12588	26564	34917725
Hypotension	42.95	14.63	176	12466	221473	34722816
Apallic syndrome	41.48	14.63	11	12631	249	34944040
Drug interaction	41.11	14.63	176	12466	225770	34718519
Arrhythmia	39.02	14.63	56	12586	35752	34908537
Atrial thrombosis	38.84	14.63	18	12624	2196	34942093
Antiacetylcholine receptor antibody positive	38.67	14.63	8	12634	57	34944232
Pacemaker generated rhythm	38.07	14.63	8	12634	62	34944227
Staring	35.64	14.63	15	12627	1455	34942834
Ventricular arrhythmia	35.20	14.63	23	12619	5505	34938784
Haemoptysis	34.19	14.63	52	12590	34954	34909335
International normalised ratio increased	33.72	14.63	61	12581	47266	34897023
Ischaemic stroke	33.42	14.63	37	12605	18213	34926076
Daydreaming	33.15	14.63	11	12631	549	34943740
Cardiac ablation	32.87	14.63	13	12629	1075	34943214
Pallor	32.50	14.63	43	12599	25437	34918852
Petit mal epilepsy	30.47	14.63	17	12625	3061	34941228
Loss of consciousness	28.74	14.63	80	12562	82587	34861702
Incontinence	27.07	14.63	20	12622	5827	34938462
Dissociation	24.56	14.63	12	12630	1646	34942643
Henoch-Schonlein purpura	24.53	14.63	12	12630	1650	34942639
Rectal haemorrhage	23.87	14.63	48	12594	40201	34904088
Long QT syndrome	23.78	14.63	14	12628	2789	34941500
Drug abuse	23.11	14.63	4	12638	99092	34845197
Presyncope	22.53	14.63	31	12611	19028	34925261
Xanthopsia	22.10	14.63	6	12636	149	34944140
BRASH syndrome	21.81	14.63	8	12634	538	34943751
Cardiac disorder	21.60	14.63	48	12594	43078	34901211
Sinus bradycardia	21.55	14.63	25	12617	12938	34931351
Heart rate abnormal	20.58	14.63	11	12631	1820	34942469
Brugada syndrome	18.84	14.63	8	12634	793	34943496
Cardiac failure congestive	18.38	14.63	69	12573	83201	34861088
Grandiosity	17.66	14.63	6	12636	322	34943967
Acquired haemophilia	17.06	14.63	8	12634	1002	34943287
Cardiac failure	16.46	14.63	71	12571	91177	34853112
Haematuria	15.97	14.63	47	12595	50019	34894270
Wolff-Parkinson-White syndrome	15.65	14.63	5	12637	221	34944068
Dyspnoea	15.60	14.63	206	12436	376576	34567713
Cardiac amyloidosis	15.44	14.63	8	12634	1243	34943046
Pressure of speech	15.25	14.63	6	12636	489	34943800
Treatment failure	15.05	14.63	44	12598	46653	34897636
Syncope	14.87	14.63	69	12573	91382	34852907
Pyrexia	14.86	14.63	66	12576	332947	34611342

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
Torsade de pointes	376.00	13.10	159	23442	19153	79701634
Atrial fibrillation	345.14	13.10	355	23246	197531	79523256
Electrocardiogram QT prolonged	283.88	13.10	226	23375	90160	79630627
Bradycardia	235.69	13.10	243	23358	135314	79585473
Ventricular tachycardia	202.33	13.10	136	23465	41799	79678988
Drug interaction	135.10	13.10	345	23256	414838	79305949
International normalised ratio increased	101.10	13.10	125	23476	84596	79636191
Arrhythmia	92.46	13.10	102	23499	61170	79659617
Atrial flutter	92.15	13.10	65	23536	21560	79699227
Palpitations	88.93	13.10	145	23456	126465	79594322
Hypotension	86.19	13.10	306	23295	440011	79280776
Ischaemic stroke	83.44	13.10	73	23528	33058	79687729
Apallic syndrome	65.21	13.10	20	23581	948	79719839
Cardiogenic shock	61.88	13.10	69	23532	41845	79678942
Ventricular arrhythmia	61.02	13.10	36	23565	8804	79711983
Sinus bradycardia	56.40	13.10	52	23549	25195	79695592
Atrial tachycardia	54.42	13.10	31	23570	7102	79713685
Long QT syndrome	51.21	13.10	28	23573	5927	79714860
Syncope	48.97	13.10	140	23461	179309	79541478
Cerebral haematoma	48.76	13.10	30	23571	7912	79712875
Atrial thrombosis	48.40	13.10	23	23578	3633	79717154
Loss of consciousness	46.77	13.10	132	23469	167811	79552976
Acute kidney injury	40.16	13.10	277	23324	519127	79201660
Cardiac arrest	40.09	13.10	127	23474	171969	79548818
Pacemaker generated rhythm	39.34	13.10	8	23593	65	79720722
Antiacetylcholine receptor antibody positive	38.91	13.10	8	23593	69	79720718
Cardiac ablation	38.73	13.10	17	23584	2236	79718551
Cardiac disorder	37.85	13.10	69	23532	65688	79655099
Rectal haemorrhage	37.67	13.10	75	23526	76225	79644562
Presyncope	37.25	13.10	53	23548	41001	79679786
Inappropriate antidiuretic hormone secretion	36.59	13.10	42	23559	26271	79694516
Haemoptysis	36.42	13.10	62	23539	55937	79664850
Erythromelalgia	35.84	13.10	9	23592	201	79720586
Joint swelling	35.05	13.10	21	23580	288625	79432162
Ventricular fibrillation	34.71	13.10	45	23556	31881	79688906
Transient ischaemic attack	33.81	13.10	58	23543	52637	79668150
Cardiac failure congestive	33.08	13.10	105	23496	142297	79578490
Sinus node dysfunction	32.46	13.10	23	23578	7678	79713109
Haemorrhagic stroke	31.19	13.10	26	23575	11020	79709767
Asthenia	30.60	13.10	257	23344	511432	79209355
Urinary incontinence	30.25	13.10	48	23553	40861	79679926
Staring	30.08	13.10	15	23586	2630	79718157
Cardio-respiratory arrest	29.91	13.10	85	23516	108425	79612362
Daydreaming	29.81	13.10	11	23590	922	79719865
Gastrointestinal haemorrhage	28.21	13.10	102	23499	147617	79573170
Hyperkalaemia	28.08	13.10	86	23515	114312	79606475
Subarachnoid haemorrhage	27.40	13.10	35	23566	24430	79696357
Haematoma	26.59	13.10	52	23549	52143	79668644
Subdural haematoma	26.22	13.10	39	23562	31395	79689392
Hyponatraemia	26.05	13.10	113	23488	177735	79543052
Atrioventricular block	25.84	13.10	26	23575	14015	79706772
BRASH syndrome	25.34	13.10	10	23591	1007	79719780
Pain	25.17	13.10	115	23486	703687	79017100
Cardiospasm	24.25	13.10	14	23587	3287	79717500
Petit mal epilepsy	23.89	13.10	17	23584	5710	79715077
Atrial rupture	22.90	13.10	5	23596	59	79720728
Palmoplantar keratoderma	22.72	13.10	14	23587	3702	79717085
Hepatocellular injury	22.55	13.10	46	23555	47547	79673240
Melaena	22.22	13.10	53	23548	60837	79659950
Nasal mucosal erosion	22.18	13.10	5	23596	69	79720718
Arthralgia	21.90	13.10	91	23510	571712	79149075
Carotid artery occlusion	21.59	13.10	18	23583	7629	79713158
Rheumatoid arthritis	21.57	13.10	18	23583	208452	79512335
Organising pneumonia	21.51	13.10	21	23580	10918	79709869
Henoch-Schonlein purpura	21.27	13.10	12	23589	2698	79718089
Systemic lupus erythematosus	21.03	13.10	5	23596	121144	79599643
Pallor	20.95	13.10	46	23555	50016	79670771
Tachycardia	20.93	13.10	106	23495	177662	79543125
Tension headache	20.42	13.10	17	23584	7194	79713593
Sleep terror	20.39	13.10	14	23587	4444	79716343
Malaise	20.35	13.10	228	23373	489641	79231146
Pruritus genital	20.31	13.10	14	23587	4472	79716315
Infection	20.30	13.10	25	23576	241687	79479100
Heart rate increased	20.26	13.10	80	23521	120644	79600143
Arthropathy	19.97	13.10	14	23587	177097	79543690
Shock haemorrhagic	19.84	13.10	27	23574	20033	79700754
Fall	19.83	13.10	226	23375	487403	79233384
Mobility decreased	19.40	13.10	6	23595	122169	79598618
Dissociation	19.28	13.10	13	23588	4008	79716779
Blood loss anaemia	18.68	13.10	23	23578	15475	79705312
Acute pulmonary oedema	18.59	13.10	22	23579	14208	79706579
Xanthopsia	18.38	13.10	6	23595	349	79720438
Musculoskeletal stiffness	18.24	13.10	15	23586	174993	79545794
Left ventricular failure	18.11	13.10	18	23583	9563	79711224
Cerebrovascular accident	17.86	13.10	92	23509	155200	79565587
Cardioactive drug level increased	17.80	13.10	12	23589	3697	79717090
Hyperthyroidism	17.73	13.10	27	23574	22182	79698605
Asthma	17.58	13.10	9	23592	135086	79585701
Medication error	17.21	13.10	52	23549	68590	79652197
Dizziness	17.11	13.10	234	23367	526207	79194580
Incontinence	17.04	13.10	21	23580	14143	79706644
Brugada syndrome	17.04	13.10	8	23593	1230	79719557
Haemorrhage intracranial	17.02	13.10	29	23572	26164	79694623
Hypoglycaemia	16.78	13.10	67	23534	101527	79619260
Cardiac failure	16.61	13.10	90	23511	154752	79566035
Hypersensitivity	16.43	13.10	33	23568	262206	79458581
Junctional ectopic tachycardia	16.01	13.10	3	23598	15	79720772
Endodontic procedure	15.92	13.10	10	23591	2733	79718054
Therapeutic product effect decreased	15.92	13.10	15	23586	163848	79556939
Cardioversion	15.69	13.10	9	23592	2089	79718698
Grandiosity	15.43	13.10	6	23595	581	79720206
Haematuria	15.28	13.10	50	23551	68786	79652001
Localised oedema	15.14	13.10	15	23586	7937	79712850
Drug intolerance	15.09	13.10	35	23566	264084	79456703
Noninfective gingivitis	14.92	13.10	8	23593	1628	79719159
Stomatitis	14.77	13.10	13	23588	146744	79574043
Visual impairment	14.61	13.10	60	23541	92071	79628716
Venous pressure increased	14.28	13.10	3	23598	29	79720758
Pressure of speech	14.07	13.10	7	23594	1221	79719566
Discomfort	14.06	13.10	10	23591	125607	79595180
Cardiac amyloidosis	14.04	13.10	8	23593	1832	79718955
Cerebral haemorrhage	13.81	13.10	43	23558	57630	79663157
Anosmia	13.81	13.10	15	23586	8829	79711958
Acquired haemophilia	13.76	13.10	8	23593	1903	79718884
Heart rate irregular	13.64	13.10	30	23571	32649	79688138
Epistaxis	13.47	13.10	67	23534	111448	79609339
Disturbance in attention	13.22	13.10	39	23562	50762	79670025

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	C07AA07	CARDIOVASCULAR SYSTEM BETA BLOCKING AGENTS BETA BLOCKING AGENTS Beta blocking agents, non-selective
ATC	C07BA07	CARDIOVASCULAR SYSTEM BETA BLOCKING AGENTS BETA BLOCKING AGENTS AND THIAZIDES Beta blocking agents, non-selective, and thiazides
ATC	C07FX02	CARDIOVASCULAR SYSTEM BETA BLOCKING AGENTS BETA BLOCKING AGENTS, OTHER COMBINATIONS Beta blocking agents, other combinations
FDA MoA	N0000000161	Adrenergic beta-Antagonists
FDA PE	N0000008330	Cardiac Rhythm Alteration
FDA EPC	N0000175426	Antiarrhythmic
MeSH PA	D018663	Adrenergic Agents
MeSH PA	D018674	Adrenergic Antagonists
MeSH PA	D000319	Adrenergic beta-Antagonists
MeSH PA	D000889	Anti-Arrhythmia Agents
MeSH PA	D002317	Cardiovascular Agents
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D013565	Sympatholytics
CHEBI has role	CHEBI:35530	beta-adrenergic blockers
CHEBI has role	CHEBI:38070	antiarrhythmic agent
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:78298	environmental contaminants

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

Disease	Relation	SNOMED_ID	DOID
Atrial fibrillation	indication	49436004	DOID:0060224
Life-Threatening Ventricular Tachycardia	indication
Bronchospasm	contraindication	4386001
Complete atrioventricular block	contraindication	27885002
Torsades de pointes	contraindication	31722008
Sick sinus syndrome	contraindication	36083008	DOID:13884
Anaphylaxis	contraindication	39579001
Hypokalemia	contraindication	43339004
Low blood pressure	contraindication	45007003
Sinus bradycardia	contraindication	49710005
Diabetes mellitus	contraindication	73211009	DOID:9351
Cardiogenic shock	contraindication	89138009
Prolonged QT interval	contraindication	111975006
Hypomagnesemia	contraindication	190855004
Second degree atrioventricular block	contraindication	195042002
Decompensated cardiac failure	contraindication	195111005
Asthma	contraindication	195967001	DOID:2841
Impaired renal function disorder	contraindication	197663003
Pregnancy, function	contraindication	289908002
Congenital long QT syndrome	contraindication	442917000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.95	acidic
pKa2	9.22	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/ML (5MG/ML)	SOTYLIZE	AZURITY	N205108	Oct. 22, 2014	RX	SOLUTION	ORAL	10206895	April 1, 2034	INDICATED FOR THE TREATMENT OF VENTRICULAR ARRHYTHMIAS, SUCH AS SUSTAINED VENTRICULAR TACHYCARDIA, THAT IN THE JUDGEMENT OF THE PHYSICIAN ARE LIFE-THREATENING
5MG/ML (5MG/ML)	SOTYLIZE	AZURITY	N205108	Oct. 22, 2014	RX	SOLUTION	ORAL	10206895	April 1, 2034	SOTYLIZE IS INDICATED FOR THE MAINTENANCE OF NORMAL SINUS RHYTHM [DELAY IN TIME TO RECURRENCE OF ATRIAL FIBRILLATION/ATRIAL FLUTTER (AFIB/AFL)] IN PATIENTS WITH SYMPTOMATIC AFIB/AFL WHO ARE CURRENTLY IN SINUS RHYTHM
5MG/ML (5MG/ML)	SOTYLIZE	AZURITY	N205108	Oct. 22, 2014	RX	SOLUTION	ORAL	9724297	Aug. 31, 2035	SOTYLIZE IS INDICATED FOR THE MAINTENANCE OF NORMAL SINUS RHYTHM [DELAY IN TIME TO RECURRENCE OF ATRIAL FIBRILLATION/ATRIAL FLUTTER (AFIB/AFL)] IN PATIENTS WITH SYMPTOMATIC AFIB/AFL WHO ARE CURRENTLY IN SINUS RHYTHM
150MG/10ML (15MG/ML)	SOTALOL HYDROCHLORIDE	ALTATHERA PHARMS LLC	N022306	July 2, 2009	RX	SOLUTION	INTRAVENOUS	10512620	Aug. 14, 2038	DOSING REGIMEN FOR INTRAVENOUS SOTALOL FOR ADMINISTRATION IN A FACILITY THAT CAN PROVIDE CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING AND CARDIAC RESUSCITATION.
150MG/10ML (15MG/ML)	SOTALOL HYDROCHLORIDE	ALTATHERA PHARMS LLC	N022306	July 2, 2009	RX	SOLUTION	INTRAVENOUS	10512620	Aug. 14, 2038	INTRAVENOUS SOTALOL DOSING REGIMEN FOR ACHIEVING STEADY STATE EXPOSURE IN A FACILITY THAT CAN PROVIDE ELECTROCARDIOGRAPHIC MONITORING
150MG/10ML (15MG/ML)	SOTALOL HYDROCHLORIDE	ALTATHERA PHARMS LLC	N022306	July 2, 2009	RX	SOLUTION	INTRAVENOUS	11696902	Aug. 14, 2038	DOSING REGIMEN FOR INTRAVENOUS SOTALOL FOR ADMINISTRATION IN A FACILITY THAT CAN PROVIDE CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING AND CARDIAC RESUSCITATION.
150MG/10ML (15MG/ML)	SOTALOL HYDROCHLORIDE	ALTATHERA PHARMS LLC	N022306	July 2, 2009	RX	SOLUTION	INTRAVENOUS	10799138	April 5, 2039	INTRAVENOUS SOTALOL DOSING REGIMEN FOR USE IN A FACILITY THAT CAN PROVIDE ELECTROCARDIOGRAPHIC MONITORING
150MG/10ML (15MG/ML)	SOTALOL HYDROCHLORIDE	ALTATHERA PHARMS LLC	N022306	July 2, 2009	RX	SOLUTION	INTRAVENOUS	10799138	April 5, 2039	USE FOR LOADING DOSE IN PATIENTS WITH SYMPTOMATIC AFIB/AFL WHO ARE CURRENTLY IN SINUS RHYTHM OR FOR THE TREATMENT OF LIFE-THREATENING VENTRICULAR TACHYCARDIA
150MG/10ML (15MG/ML)	SOTALOL HYDROCHLORIDE	ALTATHERA PHARMS LLC	N022306	July 2, 2009	RX	SOLUTION	INTRAVENOUS	11583216	Aug. 21, 2039	INTRAVENOUS SOTALOL DOSING REGIMEN FOR USE IN A FACILITY THAT CAN PROVIDE ELECTROCARDIOGRAPHIC MONITORING

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Beta-1 adrenergic receptor	GPCR	P08588	ADRB1_HUMAN	ANTAGONIST	Ki	6.10	WOMBAT-PK	CHEMBL
Beta-2 adrenergic receptor	GPCR	P07550	ADRB2_HUMAN	ANTAGONIST	Ki	6.90	WOMBAT-PK	CHEMBL
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN	BLOCKER	Ki	4	WOMBAT-PK	CHEMBL
Beta-2 adrenergic receptor	GPCR		ADRB2_BOVIN		Kd	6.24	CHEMBL
Beta-2 adrenergic receptor	GPCR		ADRB2_CANFA		IC50	5.30	CHEMBL

External reference:

ID	Source
4020814	VUID
N0000148334	NUI
D01026	KEGG_DRUG
959-24-0	SECONDARY_CAS_RN
4020779	VANDF
4020814	VANDF
C0037707	UMLSCUI
CHEBI:63622	CHEBI
CHEMBL471	ChEMBL_ID
DB00489	DRUGBANK_ID
CHEMBL1700	ChEMBL_ID
D013015	MESH_DESCRIPTOR_UI
5253	PUBCHEM_CID
7297	IUPHAR_LIGAND_ID
2350	INN_ID
A6D97U294I	UNII
1593726	RXNORM
230116	MMSL
31427	MMSL
5503	MMSL
d00371	MMSL
003453	NDDF
004111	NDDF
125691000	SNOMEDCT_US
372911006	SNOMEDCT_US
96301002	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-1060	TABLET	120 mg	ORAL	ANDA	25 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-1060	TABLET	120 mg	ORAL	ANDA	25 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-1061	TABLET	80 mg	ORAL	ANDA	25 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-1061	TABLET	80 mg	ORAL	ANDA	25 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-1062	TABLET	160 mg	ORAL	ANDA	25 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-1062	TABLET	160 mg	ORAL	ANDA	25 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-1063	TABLET	240 mg	ORAL	ANDA	25 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-1063	TABLET	240 mg	ORAL	ANDA	25 sections
Sorine	HUMAN PRESCRIPTION DRUG LABEL	1	0245-0012	TABLET	80 mg	ORAL	ANDA	28 sections
Sorine	HUMAN PRESCRIPTION DRUG LABEL	1	0245-0013	TABLET	120 mg	ORAL	ANDA	28 sections
Sorine	HUMAN PRESCRIPTION DRUG LABEL	1	0245-0014	TABLET	160 mg	ORAL	ANDA	28 sections
Sorine	HUMAN PRESCRIPTION DRUG LABEL	1	0245-0015	TABLET	240 mg	ORAL	ANDA	28 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-5552	TABLET	80 mg	ORAL	ANDA	24 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7143	TABLET	80 mg	ORAL	ANDA	25 sections
Sotalol	HUMAN PRESCRIPTION DRUG LABEL	1	10135-661	TABLET	80 mg	ORAL	ANDA	24 sections
Sotalol	HUMAN PRESCRIPTION DRUG LABEL	1	10135-662	TABLET	120 mg	ORAL	ANDA	24 sections
Sotalol	HUMAN PRESCRIPTION DRUG LABEL	1	10135-663	TABLET	160 mg	ORAL	ANDA	24 sections
Sotalol HydrochlorideAF	HUMAN PRESCRIPTION DRUG LABEL	1	10135-715	TABLET	80 mg	ORAL	ANDA	24 sections
Sotalol HydrochlorideAF	HUMAN PRESCRIPTION DRUG LABEL	1	10135-716	TABLET	120 mg	ORAL	ANDA	24 sections
Sotalol HydrochlorideAF	HUMAN PRESCRIPTION DRUG LABEL	1	10135-717	TABLET	160 mg	ORAL	ANDA	24 sections
sotalol hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	21695-397	TABLET	80 mg	ORAL	ANDA	19 sections
SOTYLIZE	HUMAN PRESCRIPTION DRUG LABEL	1	24338-530	SOLUTION	5 mg	ORAL	NDA	29 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	42806-121	TABLET	80 mg	ORAL	ANDA	14 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	42806-122	TABLET	120 mg	ORAL	ANDA	14 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	42806-123	TABLET	160 mg	ORAL	ANDA	14 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	43353-616	TABLET	80 mg	ORAL	ANDA	25 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	50090-1299	TABLET	80 mg	ORAL	ANDA	25 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	50268-724	TABLET	80 mg	ORAL	ANDA	25 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	50268-724	TABLET	80 mg	ORAL	ANDA	25 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	50268-725	TABLET	120 mg	ORAL	ANDA	25 sections