You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

MEXILETINE HYDROCHLORIDE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Mexiletine Hydrochloride, and when can generic versions of Mexiletine Hydrochloride launch?

Mexiletine Hydrochloride is a drug marketed by Ani Pharms, Annora Pharma, Crossmedika Sa, Leading, Novast Labs, Rising, Senores Pharms, Teva, and Watson Labs. and is included in ten NDAs.

The generic ingredient in MEXILETINE HYDROCHLORIDE 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 Mexiletine Hydrochloride

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

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for MEXILETINE HYDROCHLORIDE?
  • What are the global sales for MEXILETINE HYDROCHLORIDE?
  • What is Average Wholesale Price for MEXILETINE HYDROCHLORIDE?
Drug patent expirations by year for MEXILETINE HYDROCHLORIDE
Recent Clinical Trials for MEXILETINE HYDROCHLORIDE

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

SponsorPhase
Danish RegionN/A
Grete Andersen, MDN/A
Lupin Atlantis Holdings S.A.N/A

See all MEXILETINE HYDROCHLORIDE clinical trials

Pharmacology for MEXILETINE HYDROCHLORIDE
Drug ClassAntiarrhythmic
Medical Subject Heading (MeSH) Categories for MEXILETINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for MEXILETINE HYDROCHLORIDE

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
Watson Labs MEXILETINE HYDROCHLORIDE mexiletine hydrochloride CAPSULE;ORAL 074865-002 Apr 13, 1998 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs MEXILETINE HYDROCHLORIDE mexiletine hydrochloride CAPSULE;ORAL 074711-003 Feb 26, 1997 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ani Pharms MEXILETINE HYDROCHLORIDE mexiletine hydrochloride CAPSULE;ORAL 074450-001 May 16, 1996 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rising MEXILETINE HYDROCHLORIDE mexiletine hydrochloride CAPSULE;ORAL 215315-003 Aug 26, 2022 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva MEXILETINE HYDROCHLORIDE mexiletine hydrochloride CAPSULE;ORAL 074377-003 May 16, 1995 AB RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Crossmedika Sa MEXILETINE HYDROCHLORIDE mexiletine hydrochloride CAPSULE;ORAL 213500-001 Jul 22, 2020 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Annora Pharma MEXILETINE HYDROCHLORIDE mexiletine hydrochloride CAPSULE;ORAL 216463-001 Nov 9, 2022 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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".

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.