FULVICIN P/G Drug Patent Profile

Which patents cover Fulvicin P/g, and when can generic versions of Fulvicin P/g launch?

Fulvicin P/g is a drug marketed by Chartwell Rx and is included in one NDA.

The generic ingredient in FULVICIN P/G is griseofulvin, ultramicrosize. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the griseofulvin, ultramicrosize profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fulvicin P/g

A generic version of FULVICIN P/G was approved as griseofulvin, ultramicrosize by MOUNTAIN on January 9^th, 2014.

Summary for FULVICIN P/G

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	76
Patent Applications:	2,647
DailyMed Link:	FULVICIN P/G at DailyMed

Pharmacology for FULVICIN P/G

Drug Class	Tubulin Inhibiting Agent
Physiological Effect	Decreased Mitosis Microtubule Inhibition

US Patents and Regulatory Information for FULVICIN P/G

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	FULVICIN P/G	griseofulvin, ultramicrosize	TABLET;ORAL	061996-001	Approved Prior to Jan 1, 1982	AB	RX	No	No
Chartwell Rx	FULVICIN P/G 330	griseofulvin, ultramicrosize	TABLET;ORAL	061996-004	Apr 6, 1982		RX	No	No
Chartwell Rx	FULVICIN P/G	griseofulvin, ultramicrosize	TABLET;ORAL	061996-002	Approved Prior to Jan 1, 1982	AB	RX	No	No
Chartwell Rx	FULVICIN P/G 165	griseofulvin, ultramicrosize	TABLET;ORAL	061996-003	Apr 6, 1982		RX	No	No

FULVICIN P/G: Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

FULVICIN P/G, an antifungal medication, faces a mature market with established generic competition. Its financial trajectory is influenced by patent expirations, market penetration of newer therapies, and the pricing strategies of its generic counterparts.

What is FULVICIN P/G's Current Market Position?

FULVICIN P/G, marketed by Bayer, is a prescription medication used to treat fungal infections of the skin, hair, and nails. Its primary active ingredient is griseofulvin. The drug has been available for decades, leading to a well-established but increasingly competitive market landscape.

The global antifungal market is projected to reach \$23.4 billion by 2028, growing at a compound annual growth rate (CAGR) of 3.9% from 2023 to 2028 [1]. While this indicates overall market growth, FULVICIN P/G's specific segment within this market, particularly for oral griseofulvin formulations, is characterized by significant generic availability and price erosion.

Key Market Participants and Their Impact:

• Brand Name Holder (Bayer): Bayer holds the original patent for FULVICIN P/G. However, as patents expire, the market opens to generic manufacturers.
• Generic Manufacturers: A substantial number of pharmaceutical companies produce generic versions of griseofulvin. These generics offer a lower-cost alternative, directly impacting FULVICIN P/G's market share and pricing power. Examples of generic griseofulvin manufacturers include Teva Pharmaceuticals, Mylan N.V. (now Viatris), and Sandoz [2].
• Newer Antifungal Therapies: The development of newer, often more effective or convenient, antifungal medications (e.g., oral azoles like fluconazole, itraconazole, voriconazole, and posaconazole, as well as topical agents) has introduced alternative treatment options. These newer agents can draw market share away from older drugs like griseofulvin, especially for more severe or recalcitrant infections.

Geographic Market Penetration:

FULVICIN P/G has historically been prescribed in developed markets such as North America and Europe. Its presence in emerging markets is often limited by the availability and cost-effectiveness of generic alternatives and the prevalence of different fungal strains. The prescription patterns vary by region, with physicians in some areas continuing to prescribe griseofulvin due to its long track record and perceived safety profile for specific indications, while others have shifted to newer agents.

What is the Patent Expiration Status of FULVICIN P/G?

The original patents protecting FULVICIN P/G and its active pharmaceutical ingredient, griseofulvin, have long expired. Griseofulvin was first synthesized in the late 1950s, and its commercialization occurred shortly thereafter [3].

• Primary Composition of Matter Patents: Expired in the late 20th century.
• Formulation and Manufacturing Process Patents: While specific manufacturing processes or novel formulations may have received secondary patents, these have also largely expired or are of limited impact in the face of generic competition.

The lack of active patent protection means that FULVICIN P/G operates in a fully genericized market. This allows any manufacturer to produce and market griseofulvin products, leading to intense price competition.

Implications of Patent Expiration:

• Generic Entry: The market is open to multiple generic manufacturers, creating a competitive pricing environment.
• Price Erosion: Without patent exclusivity, the price of FULVICIN P/G has significantly declined from its original branded price. Generic versions are typically priced much lower.
• Market Share Dynamics: Market share is now primarily determined by factors such as manufacturing cost, distribution networks, formulary access, and marketing efforts by generic producers, rather than proprietary intellectual property.

How Has FULVICIN P/G's Financial Trajectory Evolved?

The financial trajectory of FULVICIN P/G has been characterized by a steep decline in revenue from its peak as a branded product, followed by a period of sustained, albeit lower, revenue generation driven by generic sales.

Historical Revenue Trends:

During its period of patent protection, FULVICIN P/G generated significant revenue for Bayer. Precise historical revenue figures for FULVICIN P/G as a standalone branded product are difficult to isolate from overall antifungal portfolios in publicly available financial reports from decades past. However, it is understood that branded griseofulvin medications were once substantial revenue generators.

Post-Patent Expiration Financial Performance:

Following patent expirations, the financial performance of FULVICIN P/G is largely dictated by the sales volume of generic griseofulvin.

• Reduced Profit Margins: The profit margins for generic drugs are considerably lower than those for branded pharmaceuticals due to price competition.
• Sales Volume Dependency: Revenue generation is highly dependent on maintaining significant sales volume against numerous competitors.
• Pricing Pressure: Continuous downward pressure on prices from generic competitors limits revenue growth potential. Manufacturers must focus on efficient production and cost management to remain profitable.
• Market Contraction: The overall market for oral griseofulvin may be contracting as newer, more effective antifungals gain traction. This can lead to declining sales volumes for all griseofulvin products, including FULVICIN P/G generics.

Factors Influencing Current Financials:

• Reimbursement Policies: Payer policies and formulary placements significantly influence prescribing patterns and, consequently, sales volume. Lower-cost generics are often favored.
• Healthcare Provider Prescribing Habits: Physician familiarity with griseofulvin and its established treatment protocols contribute to its continued use, despite newer alternatives.
• Global Economic Conditions: Access to healthcare and drug pricing are sensitive to economic conditions in various regions.

The financial trajectory for FULVICIN P/G and its generic equivalents is one of a mature product with limited growth prospects, where profitability relies on cost-effective manufacturing and efficient market access.

What are the Key Competitive Factors and Their Financial Impact?

The competitive landscape for FULVICIN P/G is highly fragmented and price-sensitive, directly impacting its financial viability.

Direct Competition:

• Generic Griseofulvin Products: This is the primary form of competition. Multiple manufacturers offer generic griseofulvin tablets and oral suspensions.
  • Price: The most significant competitive factor. Generic prices are driven down by supply and demand and manufacturer efficiency. A typical price for a 30-count bottle of 500mg griseofulvin tablets can range from \$15 to \$40 depending on the manufacturer and pharmacy [4]. This is a fraction of the original branded cost.
  • Availability and Distribution: Broad market access through major pharmaceutical wholesalers and pharmacies is critical.
  • Quality and Bioequivalence: Generic products must demonstrate bioequivalence to the branded drug, ensuring comparable therapeutic effect.
• Alternative Oral Antifungals: These represent indirect competition, offering different mechanisms of action and potentially improved efficacy or convenience for certain indications.
  • Terbinafine: A common alternative for dermatophytosis and onychomycosis.
  • Azole Antifungals (Fluconazole, Itraconazole, Voriconazole, Posaconazole): Broad-spectrum antifungals used for a wide range of fungal infections. These often have more favorable dosing regimens or efficacy against specific resistant strains.
  • Financial Impact: The availability of these alternatives can reduce the overall demand for griseofulvin, thereby limiting sales volume and revenue potential for all griseofulvin products.

Indirect Competition:

• Topical Antifungal Treatments: For less severe skin infections, topical agents (e.g., clotrimazole, miconazole, econazole) are often the first line of treatment and can obviate the need for oral medication.
• Diagnostic Advances: Improved diagnostic methods can lead to more targeted treatment, potentially reducing the broad-spectrum use of older oral antifungals.

Financial Impact of Competition:

• Revenue Cap: The presence of numerous generic competitors caps the revenue potential for any single griseofulvin product.
• Margin Compression: Price wars between generic manufacturers significantly compress profit margins.
• Marketing and Sales Costs: While marketing for generics is typically less intensive than for branded drugs, significant investment is still required to secure formulary access, build relationships with prescribers, and maintain market presence.

What is the Outlook for FULVICIN P/G and Related Griseofulvin Products?

The outlook for FULVICIN P/G and other oral griseofulvin products is one of a stable but declining niche within the broader antifungal market.

Market Trends:

• Continued Generic Dominance: The market for oral griseofulvin will remain dominated by generics. Brand name FULVICIN P/G sales are likely minimal or non-existent in many markets due to generic substitution.
• Evolving Treatment Guidelines: As new antifungal agents demonstrate superior efficacy, safety, or convenience, treatment guidelines are likely to shift, potentially reducing the reliance on griseofulvin for certain indications.
• Price Sensitivity: The market will remain highly price-sensitive, favoring manufacturers with the lowest production costs.
• Niche Indications: Griseofulvin may retain its place for specific, well-established indications where it remains a cost-effective and sufficiently efficacious option, particularly in resource-limited settings or for specific patient populations.
• Geographic Variations: Prescribing patterns may persist in certain regions where griseofulvin is deeply embedded in clinical practice.

Financial Outlook:

• Stable but Low Revenue: For manufacturers of generic griseofulvin, revenue is expected to remain stable but at a low level, driven by volume sales rather than price increases.
• Profitability Through Efficiency: Profitability will depend heavily on manufacturing efficiency, supply chain management, and securing favorable distribution agreements.
• Limited R&D Investment: Given the mature and genericized nature of the market, significant investment in research and development for new griseofulvin formulations or indications is unlikely.
• Potential for Consolidation: In a highly competitive generic market, there may be opportunities for consolidation as smaller manufacturers are acquired or exit the market due to profitability pressures.

Risks:

• Increased Competition: Further entry of new generic manufacturers could intensify price competition.
• Regulatory Changes: Changes in regulatory requirements or pharmacovigilance activities could impact manufacturing costs or market access.
• Emergence of Superior Alternatives: The development of significantly better antifungal treatments could accelerate the decline in griseofulvin usage.

Opportunities:

• Emerging Markets: Continued demand in emerging markets where cost is a primary consideration for antifungal treatment.
• Supply Chain Reliability: Companies that can ensure consistent supply and competitive pricing may maintain a stable market share.

The overall financial trajectory for FULVICIN P/G and its generic counterparts points to continued presence in a mature market, with revenue generation primarily from high-volume, low-margin generic sales.

Key Takeaways

• FULVICIN P/G operates in a mature, fully genericized antifungal market with extensive competition from multiple manufacturers.
• Original patents for griseofulvin have long expired, eliminating brand exclusivity and leading to significant price erosion.
• The financial trajectory has shifted from branded revenue to low-margin, high-volume generic sales, with profitability dependent on manufacturing efficiency and cost management.
• Key competitive factors are price, availability, and bioequivalence, with newer antifungal therapies posing indirect competition by offering alternative treatment options.
• The outlook is for continued stable but low revenue generation from generic griseofulvin, primarily driven by niche indications and regional prescribing habits, with limited growth prospects.

FAQs

1. What is the current approximate average retail price for a standard course of generic griseofulvin treatment? A standard course of treatment can vary significantly based on duration and dosage. For a typical 30-day supply of 500mg generic griseofulvin tablets, the retail price can range from \$20 to \$50, but this is highly variable by pharmacy, insurance coverage, and manufacturer [4].

2. Are there any new patent filings or research activities related to griseofulvin that could impact its market? Given the age of griseofulvin and the generic nature of the market, new patent filings for composition of matter or primary use are highly unlikely. Research is more likely to focus on understanding resistance mechanisms or exploring its use in combination therapies, rather than generating new patentable intellectual property for its core application.

3. How does FULVICIN P/G's efficacy compare to newer oral antifungal agents like fluconazole? Griseofulvin is primarily effective against dermatophytes (fungi that infect skin, hair, and nails). Newer agents like fluconazole have a broader spectrum of activity, including efficacy against yeasts and dimorphic fungi, and are often preferred for systemic infections or those requiring faster resolution. Griseofulvin typically requires longer treatment durations.

4. What are the primary indications for which griseofulvin is still commonly prescribed? Griseofulvin remains a treatment option for various dermatophyte infections of the skin, hair, and nails, such as ringworm (tinea corporis), athlete's foot (tinea pedis), jock itch (tinea cruris), and fungal infections of the scalp (tinea capitis) and nails (onychomycosis), particularly when topical treatments are insufficient or impractical.

5. What is the impact of payer formularies on the market share of generic griseofulvin products? Payer formularies significantly influence prescribing patterns. Generic griseofulvin products are typically placed on preferred tiers due to their low cost, often leading to higher prescription volumes compared to more expensive, newer antifungal agents, provided they meet clinical efficacy and safety profiles for the intended indications.

Citations

[1] Grand View Research. (2023). Antifungal Drugs Market Size, Share & Trends Analysis Report by Drug Class (Azoles, Echinocandins, Polyenes, Others), by Indication (Aspergillosis, Candidiasis, Dermatophytosis, Others), by End-use, by Region, and Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/antifungal-drugs-market

[2] U.S. Food & Drug Administration. (n.d.). Drugs@FDA. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/ (Note: Specific generic manufacturers can be identified through database searches for griseofulvin).

[3] Oxford University Press. (n.d.). Griseofulvin. In The Oxford Companion to Medicine. Retrieved from https://www.oxfordreference.com/view/10.1093/acref/9780198568780.001.0001/acref-9780198568780-e-3786

[4] GoodRx. (n.d.). Griseofulvin Prices, Coupons, and Patient Assistance Programs. Retrieved from https://www.goodrx.com/griseofulvin (Note: Pricing data is dynamic and subject to change).