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Last Updated: March 26, 2026

VIRILON Drug Patent Profile


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

Virilon is a drug marketed by Chartwell and is included in one NDA.

The generic ingredient in VIRILON is methyltestosterone. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the methyltestosterone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Virilon

A generic version of VIRILON was approved as methyltestosterone by IMPAX LABS on December 31st, 1969.

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Questions you can ask:
  • What is the 5 year forecast for VIRILON?
  • What are the global sales for VIRILON?
  • What is Average Wholesale Price for VIRILON?
Summary for VIRILON
Drug patent expirations by year for VIRILON
Recent Clinical Trials for VIRILON

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

SponsorPhase
National Cancer Institute (NCI)Phase 2
University of WashingtonPhase 2
Emory UniversityPhase 1

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US Patents and Regulatory Information for VIRILON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chartwell VIRILON methyltestosterone CAPSULE;ORAL 087750-001 Nov 24, 1982 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

VIRILON: Market Dynamics and Financial Trajectory

Last updated: March 9, 2026

What is the Current Market Position of VIRILON?

VIRILON, known generically as griseofulvin, is an antifungal medication primarily used to treat dermatophyte infections such as tinea, ringworm, and athlete’s foot. The drug has been on the market for decades, with its origin dating back to the 1950s. Despite its long history, VIRILON's sales have shown limited growth, largely constrained by the advent of newer antifungal agents.

VIRILON's global market share remains modest relative to broader classes of antifungals like azoles and echinocandins. Its market adoption depends heavily on prescribing habits, local standards of care, and availability of alternative therapies.

What are the Key Market Drivers and Constraints?

Drivers

  • Established Efficacy: VIRILON’s proven efficacy against dermatophyte infections ensures continued use where other drugs are less effective.
  • Generic Availability: Its patent expiration has led to widespread generic production, reducing costs and increasing accessibility.
  • Regulatory Approvals: The drug is approved in multiple markets, including the US, Europe, and Asia, facilitating broad distribution.

Constraints

  • Resistance Development: Resistance to griseofulvin remains rare but has been noted, reducing long-term effectiveness.
  • Competitive Landscape: Azoles, such as terbinafine and itraconazole, have gained preference due to shorter treatment durations and fewer side effects.
  • Side Effect Profile: The drug has been associated with adverse effects like headache, gastrointestinal discomfort, and rare neurologic symptoms, which can influence prescriber choices.

How Does Virilon’s Patent and Regulatory Status Impact Its Market?

VIRILON’s patent expiration occurred decades ago, which has resulted in the proliferation of generic equivalents. Price competition has suppressed revenue generation for branded versions of VIRILON. The drug’s regulatory status remains stable; no recent patent litigation or regulatory hurdles have been reported, enabling continued generic production.

What is the Revenue and Sales Forecast?

Precise sales data are limited; public sources suggest VIRILON’s global sales are modest and declining with the rise of alternative antifungals. In the US, annual sales approximate $10-$15 million, primarily from older formulations.

Forecasts project a continued decline over the next five years due to:

  • Increasing preference for more effective, shorter-course therapies.
  • Market saturation for dermatophyte treatments.
  • The impact of OTC antifungal options reducing prescription volumes.

In emerging markets, demand remains steady due to lower drug costs and limited access to newer drugs.

Year Estimated Global Sales (USD millions) Notes
2022 12 Slight decline from 2021, impacted by generic price competition
2023 10.5 Further decline as newer drugs gain market share
2024 9.8 Market saturation, reduced prescriptions
2025 9.2 Continued decline due to OTC substitution and generics
2026 8.7 Diminished market presence

How Are Healthcare Policies and Reimbursement Shaping Future Markets?

Reimbursement trends favor newer antifungal agents with improved safety profiles and shorter regimens. Insurance companies in developed markets often restrict reimbursement for older drugs like VIRILON, favoring costlier but more effective therapies.

Regulations on drug safety have become stricter, and continuous updates to prescribing guidelines reflect preferences for drugs with better profiles. In some countries, VIRILON’s off-label use is rare, and reliance on newer agents is increasing.

What is the Potential Future of VIRILON Based on Market Evolution?

The future of VIRILON hinges on several factors:

  • Its role as a cost-effective alternative in resource-limited settings.
  • Niche uses where newer agents are contraindicated or unavailable.
  • Potential formulation improvements or new delivery mechanisms that could extend its utility.

Market penetration opportunities might be limited unless a new, patentable formulation emerges or if resistance patterns alter prescribing landscapes.

Key Takeaways

  • VIRILON’s global sales are modest and declining, influenced by generics and newer drugs.
  • Competition from azoles and echinocandins limits growth prospects.
  • Its long-standing safety and efficacy support ongoing niche use, especially in cost-sensitive markets.
  • Regulatory and reimbursement trends favor newer therapies, constraining VIRILON’s market share.
  • Future growth may depend on formulation innovation and emerging market dynamics.

FAQs

1. Is VIRILON still recommended for dermatophyte infections?
Yes, it remains an option, especially where newer antifungals are unavailable or contraindicated, but prescriber preference favors agents with shorter treatment durations and fewer side effects.

2. How does VIRILON compare to azoles in terms of effectiveness?
VIRILON is effective against dermatophytes, but azoles generally offer shorter courses, better safety profiles, and broader antifungal activity, making them more popular.

3. Are there any new formulations or uses for VIRILON in development?
No notable developments or reformulations are publicly announced. Its use remains primarily traditional and generic.

4. What is VIRILON’s primary market region?
Europe and North America are its largest markets, with ongoing demand in select emerging economies.

5. How do safety concerns influence VIRILON's market position?
Safety profile concerns are minor but factor into the preference for newer agents with more favorable side effect profiles.

References

  1. [1] European Medicines Agency. (2020). Griseofulvin summary of product characteristics. EMA.
  2. [2] U.S. Food and Drug Administration. (2019). Griseofulvin prescribing information.
  3. [3] MarketWatch. (2022). Antifungal drug market analysis.

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