Viewing data from:

SOTALOL HYDROCHLORIDE

NDA

SOTALOL HYDROCHLORIDE | N022306 | ALTATHERA PHARMACEUTICALS LLC

1 strength8 unique patents0 unique exclusivities

Patent Timeline

8 unique patents by expiration date

Active (8)Today

2027

2028

2029

2030

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Today

Aug. 14, 2038

Apr. 5, 2039

Aug. 21, 2039

Aug. 14, 2038

Aug. 14, 2038

Aug. 14, 2028

Apr. 5, 2039

Aug. 14, 2038

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

30 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 18 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation NCT06096337	N/A	Active	Boston Scientific Corporation	484	2023-12-28 → 2028-02-04
Flecainide Safety in Patients With Coronary Artery Disease and Atrial Fibrillation NCT07405671	Phase 4	Recruiting	Universitaire Ziekenhuizen KU Leuven	988	2026-09 → 2029-12
Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation NCT02347111	Phase 4	Recruiting	University of Illinois at Chicago	162	2020-12-31 → 2026-06-30
Using Cryoballoon Ablation as Initial Treatment for Persistent Atrial Fibrillation NCT04942834	N/A	Completed	Ruijin Hospital	320	2021-10-01 → 2025-08-23
Comparing the Effects of Amiodarone, Sotalol, and Placebo in Maintaining Sinus Rhythm in Patients With Atrial Fibrillation Converted to Sinus Rhythm NCT00007605	Phase 3	Completed	US Department of Veterans Affairs	706	1998-04 → 2003-12
Optimal Pharmacological Therapy In Implantable Defibrillator Patients (OPTIC)NCT00257959	Phase 4	Completed	Connolly, Stuart, M.D.	400	2001-01 → 2004-10
Bioequivalence Study of Sotalol, Tablets, 160 mg (Pharmtechnology LLC, Belarus), and Sotalex ®, Tablets, 160 mg (Bristol-Myers Squibb GmbH & Co. KGaA, Germany), in Healthy Volunteers Under Fasting Conditions NCT03799536	Phase 1	Completed	Pharmtechnology LLC	36	2019-01-09 → 2019-02-11
Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM)NCT00000518	Phase 3	Completed	University of Utah	—	1985-07 → 1992-12
Trial to Evaluate the Efficacy and Safety of Substrate Ablation of Monomorphic Ventricular Tachycardia NCT03734562	N/A	Completed	Hospital General Universitario Gregorio Marañon	180	2010-07 → 2017-09-30
Ablation Verses Anti-arrhythmic Therapy for Reducing All Hospital Episodes From Recurrent Atrial Fibrillation NCT02459574	N/A	Completed	Imperial College London	321	2015-05-01 → 2018-11-27

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$2154.81

Highest Price

$2154.81

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
69724-0112-10SOTALOL150MG/10ML INJECTION	$2154.81	FSS	AltaThera Pharmaceuticals	08/31/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain2 active DMFs5 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SIEGFRIED LTDSOTALOL HYDROCHLORIDE

DMF 37211980

NEULAND LABORATORIES LTDSOTALOL HYDROCHLORIDE USP

DMF 149512000

IROTEC LABORATORIESInactiveSOTALOL HYDROCHLORIDE

DMF 118871996

ERREGIERRE SPAInactiveSOTALOL HYDROCHLORIDE

DMF 130831998

HEUMANN PHARMA GMBHInactiveSOTALOL HYDROCHLORIDE

DMF 131861998

SIFAVITOR SRLInactiveSOTALOL HYDROCHLORIDE

DMF 148412000

AREVIPHARMA GMBHInactiveSOTALOL HYDROCHLORIDE

DMF 237522010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Jul 25, 2025	SUPPL -8	View Letter (PDF)
Sep 22, 2023	SUPPL -6	View Letter (PDF)
Mar 13, 2020	SUPPL -5	View Letter (PDF)
Jul 9, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 150MG/10ML (15MG/ML)

RLD

8 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jul 2, 2009

Patents (8) · 10 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
10512620	Aug 14, 2038	—	—	—	—
10799138	Apr 5, 2039	—	—	—	—
11583216	Aug 21, 2039	—	—	—	—
11696902	Aug 14, 2038	—	—	—	—
12390431	Aug 14, 2038	—	—	—	—
12403109	Aug 14, 2028	—	—	—	—
12569183	Apr 5, 2039	—	—	—	—
12740947Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Aug 14, 2038	—	—	—	—