Sotalol Hydrochloride

Treats life-threatening ventricular arrhythmias the maintenance of normal sinus rhythm. Sold as Betapace, Betapace Af, Sotalol Hydrochloride, Sotylize. Every FDA application for this active ingredient: 4 branded and 17 generic.

As of Nov 15, 2026, FDA lists 21 applications for Sotalol Hydrochloride (sold as Betapace, Betapace Af, Sotalol Hydrochloride and others), first approved Oct 30, 1992, with 3 new uses approved and 0 published complete response letters.

First approved: Oct 30, 1992
Applications: 21
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $23.8M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Sotalol	Part D	$21.7M	-1%	258,498
Sotalol Af	Part D	$1.5M	-7%	18,063
Betapace	Part D	$484K	-9%	49
Betapace Af	Part D	$157K	-21%	19
Sotylize	Part D	$33K	-37%	0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

SOTALOL 120 MG TABLET: $0.105 per unitGeneric · +10% in a year
SOTALOL 160 MG TABLET: $0.130 per unitGeneric · -16% in a year
SOTALOL 240 MG TABLET: $0.207 per unitGeneric · +74% in a year
SOTALOL 80 MG TABLET: $0.071 per unitGeneric · +1% in a year
SOTYLIZE 5 MG/ML ORAL SOLUTION: $2.32 per MLBrand · +3% in a year

Orphan Designations (FDA)

2 designations, 1 approved for the designated use; see all orphan designations

Treatment of life-threatening ventricular arrhythmias in pediatric patientsArbor Pharmaceuticals, LLC · designated Feb 10, 2014
For ventricular tachycardia, ventricular fibrillation, or the maintenance of sinus rhythm in patients converted from…AltaThera Pharmaceuticals LLC · designated Jul 25, 2008 · approved Jul 2, 2009

Clinical Trials

14 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Efficacy of Early Rhythm Control in AF With TR PatientsAtrial Fibrillation (AF), Tricuspid Regurgitation (TR) · Samsung Medical Center	—	Recruiting	May 26, 2026
Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular ComplexesPremature Ventricular Complexes, Premature Ventricular Contraction (PVC) · Western Sydney Local Health District	Not applicable	Recruiting	Mar 3, 2026
Efficacy of Early Rhythm Control Therapy in Patients With Subclinical Atrial FibrillationAtrial Fibrillation (AF), Diseases of the Circulatory System · Samsung Medical Center	Not applicable	Recruiting	Mar 3, 2026
Flecainide Safety in Patients With Coronary Artery Disease and Atrial FibrillationAtrial Fibrillation (AF), Coronary Artery Disease · Universitaire Ziekenhuizen KU Leuven	Phase 4	Recruiting	Feb 12, 2026
Assessing the Neurological Outcomes After Atrial Fibrillation Ablation for Rhythm ControlAtrial Fibrillation, Stroke · Kansas City Heart Rhythm Research Foundation	—	Not yet recruiting	Jan 20, 2025
Non-Invasive Programmed Stimulation (NIPS) to Guide the Subsequent VT Therapeutic StrategiesVentricular Tachycardia (VT) · IRCCS Ospedale San Raffaele	Not applicable	Recruiting	Nov 1, 2024
Prospective Multicenter Randomized and Controlled Study Evaluating the Benefit of Early Pulmonary Vein Isolation Compared to Usual Treatment in Patients Aged Over 75 Years and Presenting With Atrial FibrillationAtrial Fibrillation · Nantes University Hospital	Not applicable	Recruiting	Mar 20, 2024
Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial FibrillationPersistent Atrial Fibrillation · Boston Scientific Corporation	Not applicable	Active, not recruiting	Oct 23, 2023

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Oct 30, 1992	BetapaceNDA 19865 · New molecular entity	Legacy	17	Marketed
Feb 22, 2000	Betapace AfNDA 21151 · TYPE 6	Legacy	6	Marketed
May 1, 2000	Sotalol HydrochlorideANDA 75237	Novitium Pharma	5	Discontinued
May 1, 2000	Sotalol HydrochlorideANDA 75366	Upsher Smith Labs	7	Discontinued
May 1, 2000	Sotalol HydrochlorideANDA 75429	Teva	10	Marketed
Jul 13, 2000	Sotalol HydrochlorideANDA 75238	Watson Labs	6	Discontinued
Nov 7, 2000	Sotalol HydrochlorideANDA 75663	Impax Pharms	4	Discontinued
Dec 19, 2000	Sotalol HydrochlorideANDA 75725	Rising	4	Discontinued
Apr 27, 2001	SorineANDA 75500	Aiping Pharm Inc	5	Marketed
Oct 15, 2001	Sotalol HydrochlorideANDA 75515	Sun Pharm Industries	2	Discontinued
Sep 26, 2002	Sotalol HydrochlorideANDA 76140	Apotex	3	Marketed
Aug 27, 2003	Sotalol HydrochlorideANDA 76214	Apotex	3	Marketed
Nov 7, 2003	Sotalol HydrochlorideANDA 75563	Oxford Pharms	6	Marketed
Apr 8, 2004	Sotalol HydrochlorideANDA 76576	Sun Pharm Industries	0	Discontinued
Jul 26, 2004	Sotalol HydrochlorideANDA 76883	Teva	0	Discontinued
Nov 4, 2005	Sotalol HydrochlorideANDA 77070	Epic Pharma LLC	0	Marketed
Feb 7, 2007	Sotalol HydrochlorideANDA 77616	Aurobindo Pharma USA	3	Marketed
Jul 2, 2009	Sotalol HydrochlorideNDA 22306 · New dosage form	Altathera Pharms LLC	5	Marketed
Oct 22, 2014	SotylizeNDA 205108 · New dosage form	Azurity	2	Marketed
Oct 21, 2016	Sotalol HydrochlorideANDA 207428	Regcon Holdings	1	Marketed
Nov 2, 2018	Sotalol HydrochlorideANDA 207429	Regcon Holdings	1	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA