Sotalol hydrochloride - Generic Drug Details

What are the generic sources for sotalol hydrochloride and what is the scope of patent protection?

Sotalol hydrochloride is the generic ingredient in five branded drugs marketed by Altathera Pharms Llc, Azurity, Legacy Pharma, Aiping Pharm Inc, Apotex, Aurobindo Pharma Usa, Beximco Pharms Usa, Epic Pharma Llc, Impax Pharms, Natco Pharma Usa, Oxford Pharms, Rising, Sun Pharm Industries, Teva, Upsher Smith Labs, and Watson Labs, and is included in twenty-one NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sotalol hydrochloride has one patent family member in one country.

There are seven drug master file entries for sotalol hydrochloride. Twenty-three suppliers are listed for this compound.

Summary for sotalol hydrochloride

International Patents:	1
US Patents:	8
Tradenames:	5
Applicants:	16
NDAs:	21
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	44
Patent Applications:	5,105
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sotalol hydrochloride
What excipients (inactive ingredients) are in sotalol hydrochloride?	sotalol hydrochloride excipients list
DailyMed Link:	sotalol hydrochloride at DailyMed

Recent Clinical Trials for sotalol hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Rush University Medical Center	N/A
HagaZiekenhuis	Phase 2/Phase 3
Abant Izzet Baysal University	N/A

See all sotalol hydrochloride clinical trials

Pharmacology for sotalol hydrochloride

Drug Class	Antiarrhythmic
Mechanism of Action	Adrenergic beta-Antagonists
Physiological Effect	Cardiac Rhythm Alteration

Medical Subject Heading (MeSH) Categories for sotalol hydrochloride

Adrenergic beta-Antagonists

Anti-Arrhythmia Agents

Sympatholytics

Anatomical Therapeutic Chemical (ATC) Classes for sotalol hydrochloride

C07AA	Beta blocking agents, non-selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for sotalol hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Legacy Pharma	BETAPACE	sotalol hydrochloride	TABLET;ORAL	019865-002	Oct 30, 1992	AB	RX	Yes	Yes
Teva	SOTALOL HYDROCHLORIDE	sotalol hydrochloride	TABLET;ORAL	076883-001	Jul 26, 2004		DISCN	No	No
Sun Pharm Industries	SOTALOL HYDROCHLORIDE	sotalol hydrochloride	TABLET;ORAL	075515-004	Oct 15, 2001		DISCN	No	No
Sun Pharm Industries	SOTALOL HYDROCHLORIDE	sotalol hydrochloride	TABLET;ORAL	075515-003	Oct 15, 2001		DISCN	No	No
Legacy Pharma	BETAPACE	sotalol hydrochloride	TABLET;ORAL	019865-005	Apr 20, 1994	AB	RX	Yes	No
Altathera Pharms Llc	SOTALOL HYDROCHLORIDE	sotalol hydrochloride	SOLUTION;INTRAVENOUS	022306-001	Jul 2, 2009		RX	Yes	Yes	11,696,902
Legacy Pharma	BETAPACE AF	sotalol hydrochloride	TABLET;ORAL	021151-005	Mar 14, 2003		DISCN	No	No

International Patents for sotalol hydrochloride

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2015153762

Sotalol hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sotalol Hydrochloride

Introduction

Sotalol hydrochloride is a versatile antiarrhythmic drug that combines nonselective beta-blocking and Class III antiarrhythmic activities. This unique pharmacologic profile makes it a crucial treatment option for various heart rhythm disorders, including ventricular and atrial arrhythmias.

Market Size and Growth

The global market for sotalol hydrochloride has been steadily growing. As of 2023, the market was valued at US$ 601 million. It is forecasted to reach US$ 869.6 million by 2030, exhibiting a Compound Annual Growth Rate (CAGR) of 5.8% during the forecast period of 2024-2030[3].

Key Players

The sotalol hydrochloride market is dominated by several key pharmaceutical companies, including:

• Bayer HealthCare
• Mylan
• Arbor Pharmaceuticals
• Upsher-Smith Laboratories
• AltaThera Pharmaceuticals
• Teva
• Apotex
• Epic Pharma

These companies play a significant role in the production, distribution, and marketing of sotalol hydrochloride products[3].

Applications and Indications

Sotalol hydrochloride is primarily used to treat:

• Ventricular Arrhythmias: It is effective in preventing recurrent ventricular tachycardia and ventricular fibrillation, which are life-threatening conditions[4].
• Atrial Arrhythmias: Although not approved for this use, sotalol has shown efficacy equivalent to propafenone and quinidine in preventing atrial fibrillation recurrence[4].

Forms and Administration

Sotalol hydrochloride is available in various forms:

• Tablets: The most common form, available in different strengths.
• Oral Solution: For patients who have difficulty swallowing tablets.
• Injection: Used in acute settings or when oral administration is not feasible[3].

Pharmacokinetics and Pharmacodynamics

Sotalol hydrochloride has a high oral bioavailability of 90-100%. It is not metabolized and is entirely renally excreted, which simplifies its dosing and reduces the risk of drug-drug interactions. The drug reaches peak plasma concentrations within 2.5 to 4 hours and achieves steady-state levels within 2-3 days[2].

Clinical Efficacy

Sotalol hydrochloride has demonstrated superior efficacy in clinical trials. For example, the Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) trial showed that sotalol had a higher in-hospital efficacy prediction rate and a lower long-term arrhythmic recurrence rate compared to class I antiarrhythmic drugs. It also has a favorable profile when used with implantable defibrillators, as it does not elevate the defibrillation threshold[4].

Side Effects and Safety

While sotalol hydrochloride is generally well-tolerated, it can cause several side effects, including:

• Common Side Effects: Related to beta-blockade, such as bradycardia, and Class III effects, such as QT interval prolongation.
• Less Common Side Effects: Changes in vision, decreased sexual performance, mood changes, and others[5].
• Rare Side Effects: Hair loss, muscle aches, and severe sunburn, among others[5].

Market Drivers

Several factors drive the growth of the sotalol hydrochloride market:

• Increasing Prevalence of Heart Rhythm Disorders: The rising incidence of arrhythmias, particularly in aging populations, increases the demand for effective treatments.
• Advantages Over Other Antiarrhythmics: Sotalol’s unique pharmacologic profile, lack of pharmacokinetic drug-drug interactions, and favorable hemodynamic tolerance make it a preferred choice for many clinicians[4].
• Growing Healthcare Expenditure: Increased spending on healthcare globally contributes to the expansion of the market.

Market Challenges

Despite its growth, the sotalol hydrochloride market faces several challenges:

• Regulatory Scrutiny: Price increases and changes in regulatory environments can impact market dynamics. For instance, some price increases must be reported if they exceed certain thresholds[1].
• Generic Competition: The presence of generic versions of sotalol hydrochloride can reduce the market share of branded products.
• Side Effect Profile: The risk of torsades de pointes and other side effects requires careful patient selection and monitoring.

Regional Market Analysis

The consumption of sotalol hydrochloride varies by region, with developed countries generally having higher market shares due to better healthcare infrastructure and higher healthcare spending. Emerging markets, however, offer significant growth opportunities due to increasing healthcare awareness and expenditure[3].

Financial Trajectory

The financial trajectory of the sotalol hydrochloride market is positive, driven by the increasing demand for effective antiarrhythmic treatments. Here are some key financial metrics:

• Revenue Forecast: The market is expected to grow from US$ 601 million in 2023 to US$ 869.6 million by 2030.
• CAGR: A CAGR of 5.8% is anticipated during the forecast period of 2024-2030[3].

Key Takeaways

• The global sotalol hydrochloride market is growing steadily, driven by its unique pharmacologic profile and increasing demand for antiarrhythmic treatments.
• Key players in the market include major pharmaceutical companies that contribute to the production and distribution of sotalol hydrochloride.
• The drug is effective in treating ventricular and atrial arrhythmias, with a favorable safety and efficacy profile.
• Despite challenges such as regulatory scrutiny and generic competition, the market is expected to continue growing.

FAQs

1. What is the primary use of sotalol hydrochloride?

Sotalol hydrochloride is primarily used to treat life-threatening heart rhythm problems, including ventricular arrhythmias and atrial arrhythmias.

2. What are the key forms in which sotalol hydrochloride is available?

Sotalol hydrochloride is available in tablets, oral solutions, and injections.

3. Which companies are major players in the sotalol hydrochloride market?

Major players include Bayer HealthCare, Mylan, Arbor Pharmaceuticals, Upsher-Smith Laboratories, AltaThera Pharmaceuticals, Teva, Apotex, and Epic Pharma.

4. What is the forecasted market size of sotalol hydrochloride by 2030?

The market is forecasted to reach US$ 869.6 million by 2030.

5. What is the CAGR of the sotalol hydrochloride market during the forecast period?

The CAGR is anticipated to be 5.8% during the forecast period of 2024-2030.

Sources:

1. Texas Department of State Health Services - 2022 Price Increase Reports
2. FDA - BETAPACE AF (sotalol HCl) Label
3. Valuates Reports - Sotalol Drug Market
4. PubMed - Sotalol: An important new antiarrhythmic
5. Mayo Clinic - Sotalol (oral route) Description