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Last Updated: January 2, 2025

MESTINON Drug Patent Profile


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

Mestinon is a drug marketed by Bausch and is included in four NDAs.

The generic ingredient in MESTINON is pyridostigmine bromide. There are eleven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the pyridostigmine bromide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Mestinon

A generic version of MESTINON was approved as pyridostigmine bromide by IMPAX LABS on April 24th, 2003.

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Summary for MESTINON
Drug patent expirations by year for MESTINON
Drug Prices for MESTINON

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Recent Clinical Trials for MESTINON

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

SponsorPhase
Eastern Virginia Medical SchoolPhase 4
Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranPhase 2/Phase 3
Brigham and Women's HospitalPhase 2

See all MESTINON clinical trials

Pharmacology for MESTINON

US Patents and Regulatory Information for MESTINON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch MESTINON pyridostigmine bromide INJECTABLE;INJECTION 009830-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bausch MESTINON pyridostigmine bromide TABLET;ORAL 009829-002 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bausch MESTINON pyridostigmine bromide SYRUP;ORAL 015193-001 Approved Prior to Jan 1, 1982 AA RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bausch MESTINON pyridostigmine bromide TABLET, EXTENDED RELEASE;ORAL 011665-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  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

MESTINON Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory of Mestinon

Introduction

Mestinon, also known as pyridostigmine bromide, is a pivotal medication in the treatment of Myasthenia Gravis, a rare neuromuscular disorder. Developed by Valeant Pharmaceuticals (now part of Bausch Health Companies), Mestinon has been a cornerstone in managing the symptoms of this condition since its introduction in the 1950s.

Historical Context

Mestinon was first launched in the United States in 1955 and has since become the drug of choice for the symptomatic treatment of Myasthenia Gravis and the reversal of nondepolarizing neuromuscular blocking agents after surgery[4].

Market Presence

Product Forms and Usage

Mestinon is available in three dosage forms: syrup, conventional tablets, and Timespan tablets. This versatility allows for tailored treatment plans to suit different patient needs. The drug works by inhibiting the enzyme acetylcholinesterase, thereby enhancing muscarinic stimulation and improving muscle strength in patients with Myasthenia Gravis[4].

Prescription Data

Historical prescription data from the 1970s indicates a steady demand for Mestinon. For example, between 1973 and 1979, the number of new and refilled prescriptions for Mestinon Bromide and Mestinon Timespan remained relatively consistent, reflecting its stable market presence[4].

Financial Performance

Revenue and Sales

Mestinon has been a significant contributor to the revenue of its parent company. Although specific annual sales figures for Mestinon alone are not readily available, it is part of Valeant's portfolio of successful products. In the early 2000s, Valeant's overall revenue was bolstered by the performance of its key products, including Mestinon. For instance, in 2006, Valeant reported a 13% increase in sales compared to the previous year, with promoted products like Mestinon contributing to this growth[3].

Generic Availability

The patent for Mestinon has expired, allowing for the production of generic versions. This has potentially impacted the revenue generated by the branded version, as generic alternatives often offer more affordable options for patients. However, the brand name and established trust in Mestinon continue to support its market presence[1].

Company Acquisitions and Mergers

Valeant's Strategic Expansion

Valeant Pharmaceuticals, the original developer of Mestinon, underwent significant changes through mergers and acquisitions. The merger with Biovail in 2010 created a new entity focused on growth and cash flow generation. This combined company leveraged its scale, financial strength, and complementary product lines to pursue substantial growth opportunities. Such strategic moves have helped maintain Mestinon's position in the market[2].

Impact on Mestinon

The integration of Valeant and Biovail led to enhanced sales growth and expanded product offerings. While the specific impact on Mestinon sales is not detailed, the overall growth strategy of the combined company would have supported the continued market presence of Mestinon.

Competitive Landscape

Current Market Dynamics

The Myasthenia Gravis treatment market includes several FDA-approved drugs, with Mestinon being one of the most established. However, the market is also seeing the emergence of new therapies. For example, drugs like Soliris (eculizumab) by Alexion Pharmaceuticals, though expensive, have become significant players. The high cost of Soliris (over $400,000 per year) highlights an unmet need for more affordable and effective treatment options, which Mestinon can partially address[1].

Future Therapies

New therapies such as Uplizna (inebilizumab-cdon), Rozanolixizumab, Zilucoplan (RA101495), and Efgartigimod (ARGX-113) are in various stages of clinical trials. These upcoming treatments may alter the market dynamics, but Mestinon's long-standing presence and efficacy ensure it remains a relevant treatment option[1].

Patient Assistance Programs

Given the chronic nature of Myasthenia Gravis and the potential cost of treatment, patient assistance programs are crucial. Programs like those offered by Simplefill help patients access Mestinon and other necessary medications, ensuring that financial constraints do not limit treatment options[5].

Key Takeaways

  • Established Market Presence: Mestinon has been a cornerstone in treating Myasthenia Gravis since 1955.
  • Financial Contribution: It has contributed significantly to the revenue of its parent company, though specific figures are not always available.
  • Generic Availability: The expiration of its patent has led to the availability of generic versions, affecting its revenue but not its market relevance.
  • Company Strategies: Mergers and acquisitions have supported the growth and market presence of Mestinon.
  • Competitive Landscape: Mestinon faces competition from new therapies but remains a vital treatment option due to its efficacy and cost relative to newer drugs.

FAQs

What is Mestinon used for?

Mestinon is used for the symptomatic treatment of Myasthenia Gravis and the reversal of nondepolarizing neuromuscular blocking agents after surgery.

When was Mestinon first introduced?

Mestinon was first launched in the United States in 1955.

What forms is Mestinon available in?

Mestinon is available in syrup, conventional tablets, and Timespan tablets.

Why is Mestinon important in the treatment of Myasthenia Gravis?

Mestinon is the drug of choice for Myasthenia Gravis due to its ability to inhibit acetylcholinesterase, thereby enhancing muscarinic stimulation and improving muscle strength.

Are there any patient assistance programs for Mestinon?

Yes, programs like Simplefill offer assistance to patients to help them afford Mestinon and other necessary medications.

How has the market for Mestinon evolved over the years?

The market for Mestinon has evolved with the introduction of new therapies, but its established presence and efficacy ensure it remains a relevant treatment option. The expiration of its patent has led to the availability of generic versions, which can affect its revenue.

Sources

  1. DelveInsight: Myasthenia Gravis Treatment Market - Companies and Therapies.
  2. Valeant Annual Report 2010: The future is clear - Annual Reports.
  3. Valeant Annual Report 2006: Valeant. Life Changing.
  4. National Toxicology Program: Nomination Background: Pyridostigmine bromide (CASRN: 101-26-8).
  5. Simplefill: Mestinon Patient Assistance Program.

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