SOTYLIZE Drug Patent Profile

When do Sotylize patents expire, and what generic alternatives are available?

Sotylize is a drug marketed by Azurity and is included in one NDA. There are four patents protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in SOTYLIZE is sotalol hydrochloride. There are ten drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sotylize

A generic version of SOTYLIZE was approved as sotalol hydrochloride by TEVA on May 1^st, 2000.

Summary for SOTYLIZE

International Patents:	1
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	110
Patent Applications:	3,064
Drug Prices:	Drug price information for SOTYLIZE
What excipients (inactive ingredients) are in SOTYLIZE?	SOTYLIZE excipients list
DailyMed Link:	SOTYLIZE at DailyMed

See drug prices for SOTYLIZE

Pharmacology for SOTYLIZE

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

US Patents and Regulatory Information for SOTYLIZE

SOTYLIZE is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	SOTYLIZE	sotalol hydrochloride	SOLUTION;ORAL	205108-001	Oct 22, 2014		RX	Yes	Yes	10,206,895		Y
Azurity	SOTYLIZE	sotalol hydrochloride	SOLUTION;ORAL	205108-001	Oct 22, 2014		RX	Yes	Yes	11,850,222
Azurity	SOTYLIZE	sotalol hydrochloride	SOLUTION;ORAL	205108-001	Oct 22, 2014		RX	Yes	Yes	9,724,297		Y
Azurity	SOTYLIZE	sotalol hydrochloride	SOLUTION;ORAL	205108-001	Oct 22, 2014		RX	Yes	Yes	11,013,703		Y

International Patents for SOTYLIZE

See the table below for patents covering SOTYLIZE around the world.

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

SOTYLIZE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sotylize (Sotalol Hydrochloride)

Market Overview

The global sotalol drug market, which includes Sotylize, is experiencing significant growth driven by several key factors.

Market Size and Growth

The global sotalol drug market was valued at USD 0.64 billion in 2023 and is projected to reach USD 1.03 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 5.8% during the forecast period[1].

Market Segmentation

By Type

The sotalol drug market is segmented into tablets, oral solutions, and injections. The approval of Sotylize, an oral solution, has expanded the treatment options for patients, particularly those who have difficulty swallowing tablets[4].

By Application

The market is also segmented based on application, primarily focusing on ventricular arrhythmias and supraventricular arrhythmias. Sotylize is specifically indicated for the treatment of life-threatening ventricular arrhythmias and the maintenance of normal sinus rhythm in patients with highly symptomatic atrial fibrillation/flutter[4].

Driving Factors

Collaborations and Research

Collaborations among pharmaceutical companies and research institutions are driving innovation and growth in the sotalol market. These partnerships lead to improved drug formulations, such as the development of Sotylize, and enhanced treatment protocols[1].

Healthcare Infrastructure

Improved healthcare facilities and infrastructure also contribute to the market's growth. Better-equipped hospitals and clinics can more effectively administer and monitor sotalol treatments, enhancing patient outcomes and safety[1].

Financial Trajectory

Cost Savings and Efficiency

Studies have shown that the use of sotalol, particularly through IV loading, can be cost-effective. For instance, a study found that using a single IV sotalol loading dose could result in significant cost savings compared to oral loading regimens, with potential savings of up to $3,803.10 compared to a 3-day oral load[2].

Revenue Growth

The approval and launch of Sotylize by Arbor Pharmaceuticals have added to the company's growing portfolio of prescription products. This expansion is expected to contribute to the overall revenue growth of the sotalol market. Arbor Pharmaceuticals, with its focus on specialty pharmaceuticals, aims to become a leading company in this sector[4].

Safety and Monitoring

Role of Pharmacists

Pharmacists play a crucial role in the safe administration of sotalol. Pharmacist-led monitoring, especially in outpatient settings, has been shown to reduce the length of hospital stays and overall healthcare costs. This approach also improves patient safety by closely monitoring QTc intervals and adjusting doses accordingly[2].

Digital Health Integration

The integration of digital health technologies, such as wearable devices, can further enhance the safety and efficacy of sotalol treatment. These tools can help in continuous monitoring and early detection of potential complications, ensuring better patient outcomes[2].

Safety Considerations

Proarrhythmic Effects

Sotylize carries a boxed warning for life-threatening proarrhythmia, including Torsades de Pointes. The risk of these events is higher in patients with certain conditions, such as reduced creatinine clearance, female sex, and higher doses. Close monitoring of the QT interval and adjustment of the dose based on renal function are critical to mitigate these risks[5].

Adverse Reactions

Common adverse reactions to Sotylize include fatigue, bradycardia, dyspnea, proarrhythmia, asthenia, and dizziness. These reactions highlight the need for careful patient selection and ongoing monitoring during treatment[5].

Regulatory Environment

FDA Approval

The FDA approval of Sotylize marked a significant milestone in the treatment of ventricular and supraventricular arrhythmias. This approval underscores the regulatory body's recognition of the drug's efficacy and safety profile, subject to careful monitoring and dose adjustment[4].

Model-Informed Drug Development

Sotalol is one of the first drugs to be approved under the new Model-Informed Drug Development regulatory path. This approach uses exposure-based biological and statistical models to enhance clinical trial efficiency and optimize drug dosing, which can further support the financial and market trajectory of sotalol products[2].

Challenges and Future Outlook

Drug Shortages

The pharmaceutical industry, including the sotalol market, faces challenges related to drug shortages. These shortages are often driven by low prices in the generic and biosimilar markets, leading to oligopolies and reduced market resilience. Addressing these issues through policy initiatives and market adjustments is crucial for maintaining a stable supply of essential medications[3].

Future Trials and Research

Future trials are necessary to validate the safety, tolerability, and cost savings of sotalol, particularly in comparison to other antiarrhythmic drugs. These studies will help in optimizing treatment protocols and further establishing the market position of Sotylize and other sotalol formulations[2].

Key Takeaways

• Market Growth: The global sotalol drug market is expected to grow at a CAGR of 5.8% from 2023 to 2032.
• Segmentation: The market is segmented by type (tablets, oral solutions, injections) and application (ventricular and supraventricular arrhythmias).
• Cost Efficiency: IV sotalol loading can be cost-effective compared to oral loading regimens.
• Safety Monitoring: Close monitoring by pharmacists and the use of digital health tools are essential for safe administration.
• Regulatory Approval: Sotylize has received FDA approval, and its development follows the Model-Informed Drug Development path.
• Challenges: The market faces challenges related to drug shortages and the need for ongoing research to optimize treatment protocols.

FAQs

What is the expected market size of the sotalol drug market by 2032?

The global sotalol drug market is expected to reach USD 1.03 billion by 2032[1].

What is the CAGR of the sotalol drug market from 2023 to 2032?

The sotalol drug market is expected to exhibit a CAGR of 5.8% from 2023 to 2032[1].

What are the primary indications for Sotylize?

Sotylize is indicated for the treatment of life-threatening ventricular arrhythmias and the maintenance of normal sinus rhythm in patients with highly symptomatic atrial fibrillation/flutter[4].

What are the common adverse reactions to Sotylize?

Common adverse reactions include fatigue, bradycardia, dyspnea, proarrhythmia, asthenia, and dizziness[5].

How can the use of IV sotalol loading be cost-effective?

Using a single IV sotalol loading dose can result in significant cost savings compared to oral loading regimens, potentially saving up to $3,803.10 compared to a 3-day oral load[2].

Sources

1. Business Research Insights: Sotalol Drug Market Size, Share, Growth, Forecast 2032.
2. Healio: Improving safety, reducing length of stay for sotalol and dofetilide initiation in AF.
3. Office of Health Economics: The Dynamics of Drug Shortages.
4. PR Newswire: Arbor Pharmaceuticals Announces FDA Approval of Sotylize™.
5. Sotylize: SOTYLIZE® (sotalol hydrochloride) oral solution.