MEXILETINE HYDROCHLORIDE - Generic Drug Details

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

Mexiletine hydrochloride is the generic ingredient in two branded drugs marketed by Ani Pharms, Annora Pharma, Crossmedika Sa, Leading, Novast Labs, Rising, Senores Pharms, Teva, Watson Labs, and Boehringer Ingelheim, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for mexiletine hydrochloride. Fourteen suppliers are listed for this compound.

Summary for MEXILETINE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	11
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	31
Patent Applications:	1,596
What excipients (inactive ingredients) are in MEXILETINE HYDROCHLORIDE?	MEXILETINE HYDROCHLORIDE excipients list
DailyMed Link:	MEXILETINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for MEXILETINE HYDROCHLORIDE

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

Sponsor	Phase
ZiteLab	N/A
GCP-Copenhagen	N/A
Region Capital Denmark	N/A

See all MEXILETINE HYDROCHLORIDE clinical trials

Pharmacology for MEXILETINE HYDROCHLORIDE

Drug Class

Antiarrhythmic

Medical Subject Heading (MeSH) Categories for MEXILETINE HYDROCHLORIDE

Anti-Arrhythmia Agents

Voltage-Gated Sodium Channel Blockers

Anatomical Therapeutic Chemical (ATC) Classes for MEXILETINE HYDROCHLORIDE

C01BB	Antiarrhythmics, class Ib
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

US Patents and Regulatory Information for MEXILETINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novast Labs	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	214352-003	Jan 25, 2021	AB	RX	No	No
Novast Labs	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	214352-002	Jan 25, 2021	AB	RX	No	No
Annora Pharma	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	216463-001	Nov 9, 2022	AB	RX	No	No
Senores Pharms	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	214089-003	Oct 1, 2021	AB	RX	No	No
Novast Labs	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	214352-001	Jan 25, 2021	AB	RX	No	No

Expired US Patents for MEXILETINE HYDROCHLORIDE

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
Boehringer Ingelheim	MEXITIL	mexiletine hydrochloride	CAPSULE;ORAL	018873-003	Dec 30, 1985	4,031,244
Boehringer Ingelheim	MEXITIL	mexiletine hydrochloride	CAPSULE;ORAL	018873-003	Dec 30, 1985	3,954,872

MEXILETINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mexiletine Hydrochloride

Introduction

Mexiletine hydrochloride, a sodium channel blocker, has been a significant player in the pharmaceutical market, particularly for the treatment of arrhythmias and nondystrophic myotonia (NDM). Here, we delve into the market dynamics and financial trajectory of this drug, exploring its current state, future projections, and the factors influencing its market performance.

Market Size and Growth Projections

The Mexiletine Hydrochloride Tablets Market has experienced substantial growth in recent years and is anticipated to continue this trend. By 2031, the market is expected to reach a significant value, driven by increasing demand and expanding applications[1].

Segmentation and Application

The market is segmented based on type (50mg/tablet, 100mg/tablet) and application (hospital pharmacy, retail pharmacy), as well as geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). This segmentation helps in understanding the diverse market dynamics and identifying key growth areas[1].

Drivers of Market Growth

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

Increasing Prevalence of Arrhythmias and NDM

The rising incidence of arrhythmias and NDM is a primary driver, as these conditions require effective treatments like mexiletine hydrochloride[3].

Regulatory Approvals and Designations

The drug's designation as an orphan drug for NDM in Europe has highlighted its importance, although it has also led to discussions on affordability and pricing[2].

Generic Market Expansion

The launch of generic versions, such as those by Lannett Company, Inc., has expanded market access and reduced costs for patients. Lannett's partnership with Rivopharm and the FDA's Competitive Generic Therapy (CGT) designation have further bolstered the generic market[4].

Restraints and Challenges

Despite the growth, several challenges affect the market:

Pricing Controversies

The significant price increase of mexiletine in Europe after its orphan drug designation has raised concerns about affordability. Cost-based pricing models suggest that the current list prices are manifold higher than justified costs[2].

Clinical Heterogeneity

The treatment of rare diseases like NDM is complicated by clinical heterogeneity, making it challenging to achieve high-quality evidence of treatment efficacy. Innovative trial designs, such as N-of-1 trials, are being used to address this issue[3].

Market Opportunities

Several opportunities are emerging in the mexiletine hydrochloride market:

Expanding Therapeutic Uses

Mexiletine's efficacy in treating muscle stiffness in NDM patients, as demonstrated in clinical trials, opens up new therapeutic avenues and potential market segments[3].

Generic Market Exclusivity

Companies like Lannett benefit from exclusivity periods granted by regulatory bodies, which can block other competitors and enhance market share[4].

Competitive Landscape

The competitive landscape of the mexiletine hydrochloride market is characterized by:

Key Players

Companies such as CSPC OUYI Pharmaceutical, Shanghai Sine Pharmaceutical Laboratories, and Lannett Company, Inc. are prominent players. These companies are involved in various market-related activities, including new product launches, partnerships, and mergers and acquisitions[1].

Market Presence

The regional and industry presence of these companies is crucial, with a focus on both established and emerging markets. The report provides detailed profiles of these companies, including their year of market entry and product offerings[1].

Financial Performance

The financial performance of the mexiletine hydrochloride market is marked by:

Revenue Projections

The market is expected to generate significant revenue over the forecast period, with projections indicating robust growth rates from 2023 to 2031[1].

Sales Data

In the U.S., total sales for mexiletine hydrochloride capsules were approximately $16 million for the 12 months ended May 2020, indicating a modest but growing market[4].

Pricing and Cost Analysis

The pricing of mexiletine hydrochloride has been a subject of debate:

Cost-Based Pricing

Studies have shown that the current list prices in Europe are significantly higher than the cost-based pricing models suggest. For example, the calculated fair price per patient per year ranges from €452 to €1996, far below the current list prices[2].

Impact on Affordability

The high prices have led to discussions on affordability and reimbursement decisions. Cost-based pricing models provide a benchmark for pricing negotiations and reimbursement decisions[2].

Clinical Efficacy and Patient Outcomes

Clinical trials have consistently shown the efficacy of mexiletine hydrochloride in reducing muscle stiffness in patients with NDM:

N-of-1 Trials

A series of aggregated N-of-1 trials demonstrated a clinically meaningful reduction in muscle stiffness, with a 100% posterior probability of reaching a clinically meaningful effect in the overall NDM group[3].

Adverse Events

Common adverse events include gastrointestinal discomfort, with one serious adverse event reported in the trials[3].

Regulatory Environment

The regulatory environment plays a crucial role in shaping the market:

Orphan Drug Designation

The designation as an orphan drug for NDM in Europe has highlighted the drug's importance but also raised pricing concerns[2].

FDA Designations

The FDA's Competitive Generic Therapy (CGT) designation for generic versions has provided exclusivity periods, influencing market competition[4].

Market Outlook and Trends

The market outlook for mexiletine hydrochloride is optimistic, driven by several trends:

Increasing Demand

The growing demand for effective treatments for arrhythmias and NDM is expected to drive market growth[1].

Innovative Trial Designs

The use of innovative trial designs, such as N-of-1 trials, is expected to provide better evidence of treatment efficacy in rare diseases[3].

Generic Market Expansion

The expansion of the generic market, with companies like Lannett launching new products, is expected to increase market access and reduce costs[4].

Key Takeaways

• Market Growth: The mexiletine hydrochloride market is projected to experience significant growth from 2023 to 2031.
• Segmentation: The market is segmented by type, application, and geography, highlighting diverse growth areas.
• Pricing Controversies: Current list prices in Europe are higher than cost-based pricing models suggest.
• Clinical Efficacy: Mexiletine hydrochloride has shown significant efficacy in reducing muscle stiffness in NDM patients.
• Regulatory Environment: Orphan drug designation and FDA's CGT designation are key regulatory factors.
• Competitive Landscape: Key players include CSPC OUYI Pharmaceutical, Shanghai Sine Pharmaceutical Laboratories, and Lannett Company, Inc.

FAQs

What is the current market size of the Mexiletine Hydrochloride Tablets Market?

The current market size of the Mexiletine Hydrochloride Tablets Market is valued in USD billion, with projections indicating significant growth by 2031[1].

What are the primary applications of mexiletine hydrochloride?

Mexiletine hydrochloride is primarily used for the treatment of arrhythmias and nondystrophic myotonia (NDM)[2][3].

Why has the pricing of mexiletine hydrochloride been controversial?

The pricing of mexiletine hydrochloride has been controversial due to the significant price increase after its designation as an orphan drug in Europe, which is manifold higher than cost-based pricing models suggest[2].

What is the impact of generic market expansion on the mexiletine hydrochloride market?

The expansion of the generic market, with companies like Lannett launching new products, is expected to increase market access and reduce costs for patients[4].

How effective is mexiletine hydrochloride in treating NDM?

Clinical trials have shown that mexiletine hydrochloride is highly effective in reducing muscle stiffness in patients with NDM, with a 100% posterior probability of reaching a clinically meaningful effect in the overall NDM group[3].

Sources

1. Market Research Intellect, "Mexiletine Hydrochloride Tablets Market Size, Scope And Forecast 2023-2031".
2. ISPOR–The Professional Society for Health Economics and Outcomes Research, "Cost-Based Price Calculation of Mexiletine for Nondystrophic Myotonia".
3. JAMA Network, "Effect of Mexiletine on Muscle Stiffness in Patients with Nondystrophic Myotonia".
4. BioSpace, "Lannett Launches Mexiletine HCl Capsules".