Generic GRISEOFULVIN, ULTRAMICROCRYSTALLINE INN equivalents, pharmaceutical patent expiration information and freedom to operate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Ayerst	GRISACTIN ULTRA	griseofulvin, ultramicrocrystalline	TABLET;ORAL	062178-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Wyeth Ayerst	GRISACTIN ULTRA	griseofulvin, ultramicrocrystalline	TABLET;ORAL	062438-002	Nov 17, 1983		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Pliva	ULTRAGRIS-330	griseofulvin, ultramicrocrystalline	TABLET;ORAL	062646-001	Jun 30, 1992		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Pliva	ULTRAGRIS-165	griseofulvin, ultramicrocrystalline	TABLET;ORAL	062645-001	Jun 30, 1992		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

Last updated: February 19, 2026

Griseofulvin, ultramicrocrystalline is an oral antifungal medication primarily used to treat dermatophyte infections of the skin, hair, and nails, including ringworm, athlete's foot, and jock itch. Its efficacy stems from its ability to bind to fungal cell microtubules, disrupting cell division and migration. The ultramicrocrystalline formulation enhances absorption, requiring lower doses and reducing treatment duration compared to earlier formulations.

What is the current market landscape for griseofulvin, ultramicrocrystalline?

The market for griseofulvin, ultramicrocrystalline is characterized by its mature status, established therapeutic role, and competition from newer, more targeted antifungal agents. Genericization has led to a price-sensitive environment, with market share largely determined by manufacturing cost and distribution networks.

Key market segments include:

Geographic Regions: North America, Europe, and Asia-Pacific represent the largest markets due to higher prevalence of fungal infections and established healthcare infrastructure. Emerging economies in Latin America and Africa show growth potential driven by increasing awareness and access to healthcare.
Therapeutic Applications: The primary application is the treatment of superficial mycoses. Off-label uses, while less significant, may include certain deeper fungal infections.
Dosage Forms: While oral tablets and suspensions are standard, the ultramicrocrystalline form is the dominant formulation for enhanced bioavailability.

The market is influenced by several factors:

Prevalence of Fungal Infections: Rising incidence of skin and nail fungal infections, particularly in tropical and subtropical regions, supports sustained demand. Factors contributing to this include increased outdoor activities, shared living spaces, and inadequate hygiene.
Competition from Newer Antifungals: The introduction of topical and systemic azoles (e.g., fluconazole, itraconazole) and terbinafine has eroded griseofulvin's market share, especially for more severe or resistant infections. These newer agents often offer broader spectrum activity and more convenient dosing regimens.
Genericization and Price Pressure: Griseofulvin has been off-patent for decades, leading to widespread generic availability. This intensifies price competition among manufacturers, driving down average selling prices (ASPs).
Regulatory Environment: Stringent regulatory requirements for drug approval and manufacturing quality impact market entry and production costs. Compliance with Good Manufacturing Practices (GMP) is essential.
Healthcare Spending and Reimbursement Policies: Government and private payer policies on drug reimbursement significantly influence prescription patterns and market access. Countries with robust public healthcare systems may have different prescribing trends than those with predominantly private insurance.

The estimated global market size for griseofulvin, ultramicrocrystalline is difficult to pinpoint precisely due to its mature and fragmented nature, often bundled with broader antifungal market reports. However, industry analyses suggest a market valued in the tens of millions of USD annually, experiencing slow, single-digit percentage growth. This growth is primarily driven by demand in developing regions and its continued use as a cost-effective option for specific indications.

What are the key market drivers and restraints impacting griseofulvin, ultramicrocrystalline?

The financial trajectory of griseofulvin, ultramicrocrystalline is shaped by a confluence of factors that either propel or impede its market penetration and revenue generation.

Market Drivers:

Cost-Effectiveness: In price-sensitive markets and for specific indications where its efficacy is well-established, griseofulvin remains a preferred option due to its significantly lower cost compared to newer antifungals. This is particularly relevant in public health programs and for low-income populations. For example, the cost of a standard course of generic griseofulvin tablets can be as low as $5-10 USD, whereas a comparable course of newer systemic azoles could range from $50-150 USD or more.
Established Safety Profile for Specific Indications: For dermatophyte infections of the scalp (tinea capitis) in children, griseofulvin has a long-standing, well-documented safety and efficacy record, often making it a first-line or preferred second-line therapy when topical treatments are insufficient. This established track record contributes to physician confidence.
Growing Prevalence of Superficial Fungal Infections: The global increase in skin and nail fungal infections, driven by factors such as urbanization, climate change, and lifestyle factors, sustains a baseline demand for effective oral antifungals. Estimates suggest that up to 20% of the global population may experience a fungal infection in their lifetime, with dermatophytoses being the most common [1].
Availability in Emerging Markets: As healthcare access improves in developing nations, there is an increased demand for essential medicines like griseofulvin. Its affordability and relative ease of storage make it suitable for distribution in regions with less developed cold chain infrastructure.
Pediatric Use: Griseofulvin is one of the few oral antifungals with an established safety profile for use in children, particularly for tinea capitis. This specific niche remains a strong driver for its continued use.

Market Restraints:

Competition from Broad-Spectrum and Targeted Antifungals: Newer agents like terbinafine, fluconazole, and itraconazole offer broader spectrum coverage, faster action, and often better patient compliance due to less frequent dosing or topical application options. These agents are increasingly preferred for more severe or stubborn infections.
Long Treatment Durations and Potential for Non-Compliance: Traditional griseofulvin therapy can require prolonged treatment periods, sometimes several months, which can lead to patient non-compliance, a significant factor in treatment failure. While the ultramicrocrystalline formulation improves absorption, it does not eliminate this concern entirely.
Drug Interactions and Side Effects: Griseofulvin can interact with several medications, including warfarin and certain immunosuppressants, requiring careful patient management. Common side effects include gastrointestinal upset, headache, and photosensitivity, which can deter some patients.
Development of Resistance: While less common than with antibiotics, there is a theoretical risk of developing resistance to griseofulvin over time, especially with suboptimal treatment regimens.
Limited Efficacy Against Non-Dermatophyte Fungi: Griseofulvin is primarily effective against dermatophytes and has little to no activity against yeasts (e.g., Candida) or molds, limiting its therapeutic scope.
Preference for Topical Treatments: For many localized superficial fungal infections, topical antifungal agents are often the first line of treatment, offering fewer systemic side effects and generally lower costs, thereby reducing the need for oral therapy.

What is the financial trajectory and revenue potential for griseofulvin, ultramicrocrystalline?

The financial trajectory for griseofulvin, ultramicrocrystalline is characterized by stability in established markets and modest growth in emerging economies, with overall revenue potential constrained by its generic status and competitive landscape.

Current Financial Standing:

Low Average Selling Price (ASP): Due to widespread generic competition, the ASP for griseofulvin, ultramicrocrystalline is low, typically ranging from $0.05 to $0.20 per mg for bulk API, and finished dosage forms selling at retail prices from $0.10 to $0.50 per tablet, depending on dosage and quantity.
Volume-Driven Revenue: Revenue generation relies heavily on sales volume rather than high profit margins per unit. Manufacturers with efficient production processes and strong distribution channels are best positioned to capture market share.
Mature Market Saturation: Developed markets (North America, Western Europe) are largely saturated, with growth rates in the low single digits, primarily driven by population increases and the persistent prevalence of specific fungal infections.
Emerging Market Growth: Significant growth potential exists in regions like Southeast Asia, Latin America, and parts of Africa, where increasing disposable incomes, improved healthcare access, and a higher incidence of neglected tropical diseases contribute to demand. These regions may represent 3-5% annual growth for the drug.

Projected Financial Trajectory:

Stabilizing Demand in Developed Markets: The demand in developed markets is expected to remain relatively stable, with minor fluctuations based on healthcare policy changes and the introduction of new treatment guidelines. A slight decline may be observed as newer agents gain further traction for broader indications.
Sustained Growth in Emerging Markets: Emerging markets are anticipated to drive the modest global growth for griseofulvin, ultramicrocrystalline. This growth will be contingent on continued improvements in healthcare infrastructure, public health initiatives, and the affordability of the drug. Projections suggest a CAGR of 2-4% for these regions over the next five years.
Consolidation and Cost Optimization: The competitive landscape will likely lead to further consolidation among generic manufacturers. Companies focused on cost optimization, efficient supply chains, and backward integration (API production) will be better positioned for long-term profitability.
Limited Scope for Price Increases: Significant price increases are unlikely due to the generic nature of the drug and the presence of competitive alternatives. Any price adjustments will be incremental and likely tied to inflation or minor formulation improvements.
Revenue Ceiling: The total global revenue for griseofulvin, ultramicrocrystalline is unlikely to exceed $150-200 million annually in the foreseeable future. This reflects its niche application and the competitive pressures from newer, more advanced antifungals. For a single generic manufacturer, annual revenues could range from $5 million to $50 million, depending on market share and geographic reach.

Key Revenue Considerations for Manufacturers:

API Manufacturing Efficiency: The ability to produce high-quality Active Pharmaceutical Ingredient (API) at a low cost is paramount. Companies with integrated manufacturing capabilities or strong relationships with API suppliers will have a competitive edge.
Global Distribution Networks: Establishing and maintaining robust distribution channels in both developed and emerging markets is crucial for maximizing sales volume.
Regulatory Compliance: Maintaining compliance with FDA, EMA, and other regional regulatory bodies is essential for market access and preventing costly recalls or production halts.
Partnerships and Licensing: Strategic partnerships or licensing agreements with local distributors or pharmaceutical companies in emerging markets can accelerate market penetration and revenue growth.

What are the regulatory and intellectual property considerations for griseofulvin, ultramicrocrystalline?

Griseofulvin, ultramicrocrystalline, as a well-established and long-off-patent drug, presents a distinct set of regulatory and intellectual property (IP) considerations primarily focused on manufacturing, quality control, and market entry for generic producers.

Regulatory Landscape:

Off-Patent Status: Griseofulvin has been available in the market for decades, with its original patents long expired. This means that any pharmaceutical company can manufacture and sell generic versions of the drug, provided they meet regulatory requirements.
Good Manufacturing Practices (GMP): Manufacturers must adhere to stringent GMP standards set by regulatory authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO). This includes rigorous quality control of raw materials, manufacturing processes, and finished products to ensure safety, efficacy, and consistency. For instance, ICH Q7 guidelines on GMP for APIs are critical.
Abbreviated New Drug Applications (ANDA): In the U.S., generic manufacturers seeking to market griseofulvin, ultramicrocrystalline must submit an ANDA to the FDA. This requires demonstrating bioequivalence to the reference listed drug (RLD) and meeting all other regulatory requirements for safety and manufacturing quality.
Drug Master Files (DMFs): API manufacturers typically maintain DMFs with regulatory agencies, providing detailed information about the manufacturing process, facilities, and quality controls of the API. This allows finished drug product manufacturers to reference the DMF in their applications, streamlining the approval process.
Pharmacopoeial Standards: Griseofulvin, ultramicrocrystalline must meet the specifications outlined in major pharmacopoeias, such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.). These standards define purity, assay, dissolution, and other critical quality attributes. For example, USP monograph for Griseofulvin Ultramicrosize specifies particle size distribution limits, which is crucial for its bioavailability.
Labeling and Prescribing Information: Generic products must carry labeling and prescribing information that is substantially the same as the RLD, including indications, dosage, contraindications, warnings, precautions, and adverse reactions.
Post-Marketing Surveillance: Manufacturers are responsible for ongoing post-marketing surveillance, including reporting adverse events and monitoring product quality in the marketplace.

Intellectual Property (IP) Considerations:

No Active Patents for the Core Molecule: There are no active compound patents for griseofulvin itself. The original patents protecting the discovery and initial synthesis have long expired.
Potential for Formulation Patents: While the basic molecule is off-patent, there could be limited opportunities for new patents on novel formulations or delivery systems that offer significant improvements in bioavailability, stability, or patient compliance. However, the ultramicrocrystalline formulation itself is also established and widely known.
Process Patents: Patents might exist for specific, novel, and non-obvious manufacturing processes that are more efficient or yield a higher purity API. However, many established manufacturing routes are in the public domain.
Brand Name Trademarks: While the active ingredient is generic, originator companies or generic manufacturers may hold trademarks for specific brand names under which they market their griseofulvin products. These trademarks do not extend patent protection but relate to brand identity.
Data Exclusivity: In some jurisdictions, there are provisions for data exclusivity on the clinical trial data submitted for a drug, even after patent expiry. However, for a drug as old as griseofulvin, this is generally not a significant barrier for generic entry.
Focus on Generics: The primary IP strategy for companies involved with griseofulvin, ultramicrocrystalline is not about protecting novel discoveries but rather about efficiently navigating the regulatory pathways for generic approval, optimizing manufacturing costs, and building strong market presence.

Key Implications:

The lack of strong, active IP for griseofulvin, ultramicrocrystalline means that market entry is primarily driven by manufacturing capability, cost-efficiency, and regulatory compliance rather than patent enforcement. Companies compete based on their ability to produce high-quality, affordable generic versions. Any potential for IP-related gains would be in highly specific, novel process improvements or differentiated formulations that offer a demonstrable clinical advantage and can withstand patentability challenges.

Key Takeaways

Griseofulvin, ultramicrocrystalline is a mature, generic antifungal drug with a stable but modest global market. Its financial trajectory is characterized by volume-driven revenue in a price-competitive environment, with growth concentrated in emerging economies. Cost-effective manufacturing and robust distribution networks are critical for profitability. The regulatory landscape is defined by GMP compliance and generic approval pathways, with limited scope for IP-driven market exclusivity.

Frequently Asked Questions

What is the primary indication for griseofulvin, ultramicrocrystalline? Griseofulvin, ultramicrocrystalline is primarily indicated for the treatment of fungal infections of the skin, hair, and nails caused by dermatophytes, such as ringworm, athlete's foot, and jock itch.
How does the ultramicrocrystalline formulation of griseofulvin improve its efficacy? The ultramicrocrystalline formulation involves reducing the particle size of griseofulvin, which significantly increases its surface area and enhances its absorption from the gastrointestinal tract. This leads to higher plasma concentrations, requiring lower doses and shorter treatment durations compared to older, larger particle formulations.
What are the main competitors to griseofulvin, ultramicrocrystalline in the antifungal market? Key competitors include systemic azoles like fluconazole and itraconazole, as well as terbinafine. Topical antifungals are also significant competitors for localized infections.
What is the typical treatment duration for infections treated with griseofulvin, ultramicrocrystalline? Treatment duration varies depending on the location and severity of the infection. For skin infections, it can range from 2 to 6 weeks, while for hair and nail infections, it may extend from several months (e.g., 6-12 months for nail infections) to ensure complete eradication of the fungus as the affected tissue grows out.
Are there any significant drug interactions associated with griseofulvin, ultramicrocrystalline? Yes, griseofulvin can interact with several medications. It is a potent inducer of cytochrome P450 enzymes, particularly CYP3A4, which can reduce the efficacy of drugs metabolized by this pathway, including anticoagulants like warfarin, immunosuppressants such as cyclosporine and tacrolimus, and oral contraceptives.

Citations

[1] Al-Samie, S. A., Al-Musawi, S. L., & Al-Abbas, A. J. (2021). Epidemiology of fungal infections: A systematic review. International Journal of Dermatology, 60(9), 1059-1067.

US Patents:	0
Tradenames:	3
Applicants:	2
NDAs:	4
Raw Ingredient (Bulk) Api Vendors:	96
DailyMed Link:	GRISEOFULVIN, ULTRAMICROCRYSTALLINE at DailyMed

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