Viewing data from:

SOTYLIZE

NDA

SOTALOL HYDROCHLORIDE | N205108 | AZURITY PHARMACEUTICALS INC

1 strength5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)Today

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

Aug. 31, 2035

Apr. 1, 2034

Apr. 1, 2034

Nov. 19, 2034

Apr. 1, 2034

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

27 trials from ClinicalTrials.gov — 1 recruiting, 17 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation NCT02347111	Phase 4	Recruiting	University of Illinois at Chicago	162	2020-12-31 → 2026-06-30
Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)NCT00000556	Phase 3	Completed	National Heart, Lung, and Blood Institute (NHLBI)	—	1995-03 → 2002-09
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
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
Antiarrhythmics or Ablation for Ventricular Tachycardia 2 NCT02830360	Phase 4	Completed	John Sapp	416	2016-10 → 2024-06-30
A Study of the Effectiveness of Anti-Arrhythmic Medications After Atrial Fibrillation Ablation NCT00408200	N/A	Completed	University of Pennsylvania	110	2006-11 → 2008-06
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
Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.NCT00035451	Phase 3	Completed	Forest Laboratories	658	2001-02 → 2003-06
A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation NCT00523978	Phase 3	Completed	Medtronic Cardiac Rhythm and Heart Failure	245	2006-10 → 2011-07
Antiarrhythmics Versus Implantable Defibrillators (AVID)NCT00000531	Phase 3	Completed	National Heart, Lung, and Blood Institute (NHLBI)	—	1992-09 → 2002-08

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$2.32

per ml

Lowest NADAC/Unit

$2.32

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
24338053025SOTYLIZE 5 MG/ML ORAL SOLUTION	$2.32	ML	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$386.13

Highest Price

$788.97

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
24338-0530-25SOTYLIZE 5MG/ML SOLN	$410.64	FSS	Azurity Pharmaceuticals, Inc.	07/31/2026
24338-0530-25SOTYLIZE 5MG/ML SOLN	$386.13	Big4	Azurity Pharmaceuticals, Inc.	07/31/2026
24338-0530-48SOTYLIZE 5MG/ML SOLN	$788.97	FSS	Azurity Pharmaceuticals, Inc.	07/31/2026
24338-0530-48SOTYLIZE 5MG/ML SOLN	$741.62	Big4	Azurity Pharmaceuticals, Inc.	07/31/2026

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

Medicare Part D Spending

CMS annual spending data for Sotylize (2024)

Total Spending

$52K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$2.11

Spending Trend

$45K(2019)→$28K(2020)→$57K(2021)→$45K(2022)→$18K(2023)→$52K(2024)

YoY Change:+7.9%

5yr CAGR:+5.0%

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

API Supply Chain3 active DMFs5 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

SIEGFRIED LTDSOTALOL HYDROCHLORIDE

DMF 37211980

NEULAND LABORATORIES LTDSOTALOL HYDROCHLORIDE USP

DMF 149512000

APISYN HEALTHCARE PRIVATE LTDSOTALOL HYDROCHLORIDE USP

DMF 434032026

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

2 letters from Drugs@FDA

Date	Submission	Document
Jan 16, 2024	SUPPL -3	View Letter (PDF)
Dec 18, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG/ML (5MG/ML)

RLD

5 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Oct 22, 2014

Patents (5) · 7 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9724297	Aug 31, 2035	—	—	Yes		—
10206895	Apr 1, 2034	—	—	Yes		—
11013703	Apr 1, 2034	—	—	Yes	—	—
11850222	Nov 19, 2034	—	—	—		—
12290495	Apr 1, 2034	—	—	—		—