MEXITIL Drug Patent Profile

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

Mexitil is a drug marketed by Boehringer Ingelheim and is included in one NDA.

The generic ingredient in MEXITIL is mexiletine hydrochloride. There are five drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the mexiletine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mexitil

A generic version of MEXITIL was approved as mexiletine hydrochloride by TEVA on May 16^th, 1995.

Summary for MEXITIL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	214
Clinical Trials:	4
Patent Applications:	5,267
DailyMed Link:	MEXITIL at DailyMed

Recent Clinical Trials for MEXITIL

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

Sponsor	Phase
Massachusetts General Hospital	Phase 2
Spaulding Clinical Research LLC	Phase 1
Food and Drug Administration (FDA)	Phase 1

See all MEXITIL clinical trials

US Patents and Regulatory Information for MEXITIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	MEXITIL	mexiletine hydrochloride	CAPSULE;ORAL	018873-002	Dec 30, 1985		DISCN	Yes	No
Boehringer Ingelheim	MEXITIL	mexiletine hydrochloride	CAPSULE;ORAL	018873-003	Dec 30, 1985		DISCN	Yes	No
Boehringer Ingelheim	MEXITIL	mexiletine hydrochloride	CAPSULE;ORAL	018873-004	Dec 30, 1985		DISCN	Yes	No

Expired US Patents for MEXITIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	MEXITIL	mexiletine hydrochloride	CAPSULE;ORAL	018873-004	Dec 30, 1985	3,954,872
Boehringer Ingelheim	MEXITIL	mexiletine hydrochloride	CAPSULE;ORAL	018873-002	Dec 30, 1985	3,954,872
Boehringer Ingelheim	MEXITIL	mexiletine hydrochloride	CAPSULE;ORAL	018873-004	Dec 30, 1985	4,031,244

International Patents for MEXITIL

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	1205957
United Kingdom	1205956
Switzerland	509250	Verfahren zur Herstellung neuer substituierter 1-Phenoxy-2-aminopropane (1-Phenoxy-2-aminoalkanes)

MEXITIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mexiletine Hydrochloride Tablets (Mexitil)

Introduction to Mexiletine Hydrochloride Tablets

Mexiletine hydrochloride, marketed under the brand name Mexitil, is a class 1B antiarrhythmic agent used primarily for the treatment of documented ventricular arrhythmias, including ventricular tachycardia and symptomatic premature ventricular beats, as well as the prevention of ventricular fibrillation[3].

Market Size and Growth Projections

The Mexiletine Hydrochloride Tablets market has experienced significant growth in recent years and is projected to continue this trend. The market size is expected to expand substantially from 2023 to 2031, driven by increasing demand for effective treatments for ventricular arrhythmias. The positive market dynamics and optimistic outlook suggest robust growth rates in the foreseeable future[1].

Segmentation of the Market

The market is segmented based on several key factors:

• Type: The market is categorized into 50mg and 100mg tablets, each serving different patient needs and treatment protocols.
• Application: The primary applications are in hospital pharmacies and retail pharmacies, reflecting the diverse distribution channels for the drug.
• Geography: The market is analyzed across various regions, including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa, highlighting regional variations in demand and market penetration[1].

Drivers of Market Growth

Several factors are driving the growth of the Mexiletine Hydrochloride Tablets market:

• Increasing Prevalence of Ventricular Arrhythmias: The rising incidence of heart conditions that require antiarrhythmic treatments is a significant driver.
• Advancements in Healthcare Infrastructure: Improved healthcare facilities and increased access to medical services in various regions contribute to the market's expansion.
• Growing Awareness and Diagnosis: Enhanced diagnostic capabilities and greater awareness among patients and healthcare providers about ventricular arrhythmias are boosting demand for Mexiletine hydrochloride tablets[1].

Restraints and Challenges

Despite the positive growth trajectory, the market faces several challenges:

• Side Effects and Adverse Reactions: Mexiletine can cause various side effects, including nausea, hypotension, and cardiac complications, which may deter some patients.
• Regulatory Hurdles: Strict regulatory requirements and the need for continuous monitoring of drug safety can slow market growth.
• Competition from Alternative Treatments: The presence of other antiarrhythmic agents and emerging treatments could pose a competitive threat to Mexiletine hydrochloride tablets[1][3].

Opportunities and Future Prospects

The market presents several opportunities for growth and expansion:

• Emerging Markets: Regions like Asia-Pacific and South America offer significant potential due to their large populations and growing healthcare needs.
• Research and Development: Continuous R&D efforts to improve the efficacy and safety of Mexiletine hydrochloride tablets can enhance market appeal.
• Partnerships and Collaborations: Strategic partnerships between pharmaceutical companies and healthcare providers can increase market penetration and accessibility[1].

Competitive Landscape

The competitive landscape of the Mexiletine Hydrochloride Tablets market is characterized by:

• Key Players: Companies such as CSPC OUYI Pharmaceutical, Shanghai Sine Pharmaceutical Laboratories, Dandong Yichuang Pharmaceutical, Jilin Jinheng Pharmaceutical, and Yangzhou Aidea Pharmaceutical are prominent players in the market.
• Market Strategies: These companies engage in various strategies including new product launches, partnerships, mergers and acquisitions, and regional expansion to maintain their market position[1].

Financial Trajectory

The financial trajectory of the Mexiletine Hydrochloride Tablets market is marked by:

• Revenue Growth: The market is expected to generate significant revenue, measured in USD million, across the forecast period from 2023 to 2031.
• Pricing Analysis: The report includes a detailed pricing analysis, highlighting the degree of product penetration at national and regional levels, which influences the overall revenue.
• Economic and Political Factors: The market is influenced by broader economic and political landscapes, including fiscal policies and global economic trends. For instance, Mexico's fiscal policy aims to maintain a healthy public finance trajectory, which can impact the pharmaceutical sector[1][5].

Macrofinancial Risks and Stability

The financial stability of the market is also subject to macrofinancial risks, such as:

• Tighter Financial Conditions: Prolonged periods of tight financial conditions could impact market growth.
• Geopolitical Tensions: Increased geopolitical tensions can lead to volatility in financial markets, affecting the performance of pharmaceutical companies.
• Systemic Events: Global systemic events, such as economic downturns or major financial crises, can have a significant impact on the market's stability[2].

Consumer Behavior and Market Trends

Consumer behavior and market trends play a crucial role in shaping the Mexiletine Hydrochloride Tablets market:

• Increasing Demand for Effective Treatments: Patients and healthcare providers are increasingly seeking effective treatments for ventricular arrhythmias, driving demand for Mexiletine hydrochloride tablets.
• Shift to Retail Pharmacies: There is a growing trend towards purchasing medications from retail pharmacies, which is influencing the distribution strategies of pharmaceutical companies[1].

Regulatory Environment

The regulatory environment is a critical factor in the market dynamics of Mexiletine Hydrochloride Tablets:

• Approval and Compliance: The drug must comply with stringent regulatory requirements, and any changes in regulatory policies can impact market dynamics.
• Safety Monitoring: Continuous monitoring of drug safety and adverse reactions is essential to maintain regulatory approval and consumer trust[3].

Key Takeaways

• The Mexiletine Hydrochloride Tablets market is experiencing rapid growth driven by increasing demand for antiarrhythmic treatments.
• The market is segmented by type, application, and geography, with key players dominating the competitive landscape.
• Despite challenges such as side effects and regulatory hurdles, the market presents significant opportunities for growth, especially in emerging markets.
• Financial stability is influenced by macrofinancial risks and broader economic trends.

FAQs

1. What is Mexiletine hydrochloride used for?

Mexiletine hydrochloride is used for the treatment of documented ventricular arrhythmias, including ventricular tachycardia and symptomatic premature ventricular beats, as well as the prevention of ventricular fibrillation[3].

2. What are the key drivers of the Mexiletine Hydrochloride Tablets market?

The key drivers include the increasing prevalence of ventricular arrhythmias, advancements in healthcare infrastructure, and growing awareness and diagnosis of heart conditions[1].

3. Which companies are the major players in the Mexiletine Hydrochloride Tablets market?

Major players include CSPC OUYI Pharmaceutical, Shanghai Sine Pharmaceutical Laboratories, Dandong Yichuang Pharmaceutical, Jilin Jinheng Pharmaceutical, and Yangzhou Aidea Pharmaceutical[1].

4. What are the potential risks and challenges facing the Mexiletine Hydrochloride Tablets market?

Potential risks include side effects and adverse reactions, regulatory hurdles, and competition from alternative treatments[1][3].

5. How does the broader economic and political landscape impact the Mexiletine Hydrochloride Tablets market?

The market is influenced by fiscal policies, global economic trends, and macrofinancial risks such as tighter financial conditions and geopolitical tensions[1][2][5].

Cited Sources:

1. Market Research Intellect - Mexiletine Hydrochloride Tablets Market Size, Scope And Forecast.
2. Banco de México - Executive Summary of the Financial Stability Report.
3. DrugBank Online - Mexiletine: Uses, Interactions, Mechanism of Action.
4. News Channel Nebraska - Mexiletine Hydrochloride Tablets Market 2024 Growth Dynamics.
5. Proyectos México - Fiscal Policy.