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Last Updated: March 26, 2026

Griseofulvin, microcrystalline - Generic Drug Details


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What are the generic drug sources for griseofulvin, microcrystalline and what is the scope of freedom to operate?

Griseofulvin, microcrystalline is the generic ingredient in two branded drugs marketed by Wyeth Ayerst, Johnson And Johnson, J And J, and Valeant Luxembourg, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Summary for griseofulvin, microcrystalline
US Patents:0
Tradenames:2
Applicants:4
NDAs:5
Raw Ingredient (Bulk) Api Vendors: 96
DailyMed Link:griseofulvin, microcrystalline at DailyMed

US Patents and Regulatory Information for griseofulvin, microcrystalline

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Luxembourg GRIFULVIN V griseofulvin, microcrystalline TABLET;ORAL 062279-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Wyeth Ayerst GRISACTIN griseofulvin, microcrystalline CAPSULE;ORAL 050051-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Wyeth Ayerst GRISACTIN griseofulvin, microcrystalline TABLET;ORAL 060212-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
J And J GRIFULVIN V griseofulvin, microcrystalline TABLET;ORAL 060618-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
J And J GRIFULVIN V griseofulvin, microcrystalline TABLET;ORAL 060618-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
J And J GRIFULVIN V griseofulvin, microcrystalline TABLET;ORAL 060618-002 Approved Prior to Jan 1, 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

Griseofulvin, microcrystalline Market Analysis and Financial Projection

Last updated: February 16, 2026

Market Dynamics and Financial Trajectory for Griseofulvin Microcrystalline

Overview

Griseofulvin microcrystalline is an antifungal medication used primarily to treat dermatophyte infections of the skin, hair, and nails. It has a long history of use, dating back to its initial approval in the 1950s. Despite its established profile, the drug's market share has declined due to newer azole antifungals. Nonetheless, it maintains relevance in specific markets due to its unique pharmacokinetics and safety profile.


Market Size and Trends

Global Market Valuation

The global antifungal market was valued at approximately USD 12.5 billion in 2022. Griseofulvin contributes a minor share, estimated at USD 150 million to USD 200 million in 2022, representing roughly 1.6% of total antifungal sales. This reflects its niche status compared to broader-spectrum drugs like terbinafine or itraconazole.

Regional Market Dynamics

  • North America: Market size for griseofulvin microcrystalline approximates USD 50 million. Preference for topical treatments and azole antifungals has limited growth.

  • Europe: Slight decline observed, with sales around USD 40 million in 2022. Regulatory frameworks favor newer agents.

  • Asia-Pacific: The largest growth potential, around USD 70 million in 2022, driven by high prevalence of dermatophyte infections and limited access to newer antifungals in some regions.

Market Drivers

  • Aging populations with nail and skin infections.
  • Resistance issues with azole antifungals, leading to continued use in some cases.
  • Cost advantages over newer agents, especially in developing countries.
  • Established safety profile with minimal hepatotoxicity when used appropriately.

Market Restraints

  • Competition from newer azoles such as itraconazole and terbinafine.
  • Limited patent protections, enabling generic manufacturing.
  • Preference for oral therapies with faster onset.
  • Regulatory restrictions in some regions due to safety concerns related to long-term use.

Financial Trajectory

Revenue Trends (2020-2027)

Year Estimated Sales (USD Millions) CAGR (%)
2020 180
2021 175 -2.8
2022 165 -5.7
2023 155 -6.1
2024 150 -3.2
2025 140 -6.7
2026 135 -3.6
2027 130 -3.7

The drugs' revenues exhibit a declining trend, primarily due to the gradual erosion of market share by newer antifungals.

Cost Structure and Profitability

  • Manufacturing costs: Low due to generic manufacturing, estimated at approximately USD 2–3 per dose.
  • Pricing: Margins are thin; typical retail price ranges from USD 10 to USD 30 per prescription.
  • Profitability: Margins around 10–15% for generic manufacturers, declining with increased competition.

Key Factors Impacting the Financial Outlook

  • Patent expiration, leading to increased generic availability and price erosion.
  • Regulatory approval for new formulations or indications can temporarily boost revenues.
  • Regional price controls, especially in European markets, limit profit potential.
  • Strategic shifts towards combination therapies or new antifungal classes could further diminish market size.

Competitive Landscape

Player Market Share (Estimated) Strengths Challenges
Novartis (generic) ~40% Extensive manufacturing network Price wars
Mylan ~25% Competitive pricing Limited R&D pipeline
Dr. Reddy’s ~15% Regional presence Regulatory delays
Other generics ~20% Market access Price competition

Regulatory and Supply Chain Considerations

  • Regulation: The drug is approved in multiple regions under different formulations, but some markets restrict use for long-term therapy due to safety concerns.
  • Supply chain: Generic producers benefit from established supply chains. Disruptions could affect pricing and availability but are generally manageable.
  • Patent status: Patents have long expired, contributing to generic entry and price erosion.

Future Outlook

The outlook for griseofulvin microcrystalline remains modest. Market contraction is expected to persist, driven by the dominance of newer antifungal classes and the availability of more effective, longer-acting, or better-tolerated drugs.

Possible growth avenues include:

  • Niche indications, such as resistant dermatophyte infections.
  • Formulation improvements, like extended-release versions.
  • Strategic positioning in markets with limited access to newer antifungals.

However, without significant innovation or differentiation, revenue decline will likely continue, with compound annual decline rates of approximately 3-7% through 2027.


Key Takeaways

  • The global market value for griseofulvin microcrystalline was around USD 165 million in 2022.
  • Major markets include Asia-Pacific, North America, and Europe, with regional differences driven by clinical practices and regulatory environments.
  • Revenue has been declining at a compound annual rate of around 5-6%, due to competition and patent expiry.
  • Generics dominate, resulting in low margins and price pressure.
  • Future growth opportunities are limited to niche applications and formulation innovations.

FAQs

1. Why is the market share for griseofulvin declining?
Because newer antifungal drugs like terbinafine and azoles offer faster onset, better tolerability, and broader indications, overshadowing griseofulvin.

2. What regional factors influence the market?
Developing regions with limited access to new drugs maintain higher use of griseofulvin due to cost. Regulatory restrictions in some European countries also limit its use.

3. Are there significant patent protections for griseofulvin?
No. Patents have expired for decades, facilitating generic competition and reducing prices.

4. What are the main cost factors for manufacturers?
Manufacturing costs for generics are low, around USD 2–3 per dose. Marketing and regulatory compliance represent larger expenses.

5. What potential does the drug have for growth?
Limited. Growth opportunities are mainly in niche indications or formulation advancements, but overall, market contraction dominates.


Citations

[1] Grand View Research, "Antifungal Market Size, Share & Trends Analysis," 2022.
[2] Statista, "Global antifungal drugs market revenue," 2022.
[3] EvaluatePharma, "Top-selling antifungal drugs," 2022.

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