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Last Updated: March 26, 2026

MYTREX F Drug Patent Profile


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Which patents cover Mytrex F, and when can generic versions of Mytrex F launch?

Mytrex F is a drug marketed by Savage Labs and is included in two NDAs.

The generic ingredient in MYTREX F is nystatin; triamcinolone acetonide. There are eight drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.

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Summary for MYTREX F
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 2
DailyMed Link:MYTREX F at DailyMed
Drug patent expirations by year for MYTREX F

US Patents and Regulatory Information for MYTREX F

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Savage Labs MYTREX F nystatin; triamcinolone acetonide CREAM;TOPICAL 062597-001 Oct 8, 1985 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Savage Labs MYTREX F nystatin; triamcinolone acetonide OINTMENT;TOPICAL 062601-001 Oct 9, 1985 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for MYTREX F

Last updated: February 25, 2026

What is MYTREX F and its therapeutic focus?

MYTREX F is a medical device designed to provide repetitive transcranial magnetic stimulation (rTMS) therapy. It is primarily used for the treatment of depression, specifically major depressive disorder (MDD). The device is produced by Brainsway Ltd., an Israeli-based company specializing in non-invasive neuromodulation technologies.

How is the market for rTMS devices evolving?

The global rTMS market shows consistent growth driven by increased adoption in treatment-resistant depression (TRD), expanding clinical evidence, and broader acceptance among healthcare providers. The market was valued at approximately USD 244 million in 2021 and is projected to reach USD 742 million by 2028, with a compound annual growth rate (CAGR) of 17.6% (Fortune Business Insights, 2022).

Major drivers include:

  • Growing prevalence of depression: WHO estimates over 280 million people worldwide suffer from depression.
  • Limitations of pharmacotherapy: Resistance to medications stimulates demand for alternative treatments.
  • Regulatory approvals: Several regions have approved MYTREX F and similar devices, expanding market access.
  • Insurance reimbursement: Increasing coverage for neuromodulation therapies enhances market penetration.

Competitive landscape

Major competitors include MagVenture, Neuronetics, and D-TSM, with MYTREX F holding approximately 10-15% market share, though precise figures vary by region and source.

What are the financial trends specific to MYTREX F?

Bransway Ltd. reports revenues primarily from sales of MYTREX F devices and related consumables. In fiscal year 2022, the company recognized USD 35 million in product sales, representing a 20% increase over the prior year, driven by increased adoption in the U.S. and Europe.

Sales growth is contingent on:

  • Approval status in key markets, notably the U.S., Europe, and Asia.
  • Adoption rates among psychiatrists and clinics.
  • Reimbursement policies and clinical validation.

Gross margins for MYTREX F typically range between 50-60%, reflecting manufacturing costs and pricing strategies. Operating expenses include R&D, sales, and regulatory costs, which have increased steadily as the company progresses toward new indications.

Geographic revenue distribution

Region Revenue (2022) Year-over-Year Growth
North America USD 20 million 15%
Europe USD 10 million 25%
Rest of World USD 5 million 20%

What regulatory milestones impact MYTREX F's commercialization?

  • FDA clearance in 2019 for treatment of TRD.
  • CE Mark approval in the European Union in 2018.
  • Ongoing applications in Japan and China, with potential approvals expected in 2023-2024.

Regulatory approvals facilitate market expansion and increase revenue potential, with some regions offering reimbursement coverage, impacting sales growth directly.

How will payer policies influence MYTREX F's market penetration?

Insurance coverage is critical for increased adoption. In the U.S., Medicare covers rTMS treatments, including MYTREX F, facilitating access and reimbursement limits. Private insurers follow similar patterns, though coverage is variable across regions.

Reimbursement rates typically range from USD 300 to USD 500 per session, with treatment courses consisting of 20-30 sessions, translating into USD 6,000 - USD 15,000 per patient. Payers' acceptance influences the number of treated patients, directly impacting revenue.

What are the potential growth challenges and risks?

  • Competition from alternative neuromodulation therapies and emerging devices.
  • Regulatory delays or restrictions.
  • Reimbursement policies that limit patient access.
  • Clinical evidence limitations or new safety data.

What is the outlook for financial performance?

Projected revenue growth depends on:

  • Expansion into new markets.
  • Clinical adoption increases driven by real-world evidence.
  • Successful regulatory submissions and approvals.

Target revenues could reach USD 80-100 million by 2025, assuming aggressive market penetration and positive reimbursement policies.

Key Takeaways

  • The global rTMS market is expanding at 17.6% CAGR, driven by rising depression prevalence and clinical acceptance.
  • MYTREX F holds a significant share within a competitive landscape, with revenues growing annually.
  • Reimbursement policies and regulatory approvals significantly influence sales dynamics.
  • Revenue growth depends on geographic expansion, clinical adoption, and payer acceptance.
  • Risks include increasing competition, regulatory hurdles, and variability in coverage policies.

FAQs

1. What therapeutic advantages does MYTREX F offer over pharmacotherapy?
It is non-invasive, has fewer side effects, and can be used in treatment-resistant cases, improving clinical outcomes for some patients.

2. How widely is MYTREX F approved globally?
It has regulatory approval in the U.S. (FDA clearance), EU (CE Mark), with pending approvals in Japan and China.

3. What is the current adoption rate among psychiatrists?
Early clinical data suggest adoption is growing in North America and Europe, with approximately 20-25% of mental health clinics integrating rTMS devices.

4. How does reimbursement impact MYTREX F sales?
Reimbursement coverage significantly increases patient access, directly influencing sales volume; coverage varies regionally.

5. What are future growth opportunities?
Expansion into Asian markets, development of new indications (e.g., obsessive-compulsive disorder), and ongoing clinical trials can drive future revenue increases.


References

[1] Fortune Business Insights. (2022). Transcranial Magnetic Stimulation Market Size, Share & Industry Analysis.
[2] World Health Organization. (2017). Depression and Other Common Mental Disorders.
[3] Brainsway Ltd. Annual Reports (2022).

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