Viewing data from:

BETAPACE

NDA

SOTALOL HYDROCHLORIDE | N019865 | LEGACY PHARMA INC SEZC

5 strengths0 unique patents0 unique exclusivities

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

29 trials from ClinicalTrials.gov — 1 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
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
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
Genetic Sources of Variability of the Adaptation of the Ventricular Repolarisation NCT00773201	Phase 1	Completed	Assistance Publique - Hôpitaux de Paris	997	2008-02 → 2012-03
Prospective Randomized Clinical Trial of Fetal Atrial Flutter & Supraventricular Tachycardia Therapy (FAST RCT)NCT02624765	Phase 3	Completed	Edgar Jaeggi	105	2016-02 → 2024-03-31

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Medicare Part D Spending

CMS annual spending data for Betapace (2024)

Total Spending

$535K

Total Claims

197

Beneficiaries

Avg Cost/Unit

$26.84

Spending Trend

$1.3M(2019)→$1.2M(2020)→$893K(2021)→$722K(2022)→$677K(2023)→$535K(2024)

YoY Change:-1.7%

5yr CAGR:+5.4%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

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

6 letters from Drugs@FDA

Date	Submission	Document
Jun 23, 2023	SUPPL -26	View Letter (PDF)
Jun 7, 2021	SUPPL -22	View Letter (PDF)
May 17, 2016	SUPPL -21	View Letter (PDF)
Aug 18, 2011	SUPPL -20	View Letter (PDF)
Feb 9, 2011	SUPPL -19	View Letter (PDF)
Oct 1, 2001	SUPPL -10	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 80MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 30, 1992

No patent or exclusivity listings for this strength.

#002 — 160MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 30, 1992

#003 — 240MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 30, 1992

#004 — 320MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 30, 1992

#005 — 120MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 20, 1994