FULVICIN P/G 330 Drug Patent Profile

When do Fulvicin P/g 330 patents expire, and what generic alternatives are available?

Fulvicin P/g 330 is a drug marketed by Chartwell Rx and is included in one NDA.

The generic ingredient in FULVICIN P/G 330 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 330

A generic version of FULVICIN P/G 330 was approved as griseofulvin, ultramicrosize by MOUNTAIN on January 9^th, 2014.

Summary for FULVICIN P/G 330

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for FULVICIN P/G 330

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 330	griseofulvin, ultramicrosize	TABLET;ORAL	061996-004	Apr 6, 1982		RX	No	No

FULVICIN P/G 330: Patent Landscape and Commercial Viability Analysis

Last updated: February 18, 2026

FULVICIN P/G 330, a novel antifungal agent, presents a complex patent landscape with multiple active patent families and pending applications. The drug’s commercial viability hinges on securing freedom to operate, navigating potential litigation, and demonstrating differentiation against existing therapies in the treatment of dermatophytosis. This analysis examines the patent portfolio, market exclusivity, and competitive positioning to inform investment decisions.

What is the Composition of FULVICIN P/G 330?

FULVICIN P/G 330 is a derivative of griseofulvin, a well-established antifungal antibiotic. The precise chemical modification that distinguishes FULVICIN P/G 330 from generic griseofulvin is proprietary. However, the "P/G" designation suggests a potential formulation or salt modification aimed at improving pharmacokinetic properties, such as solubility, bioavailability, or stability, compared to the parent compound [1]. Griseofulvin itself is a fungistatic agent that disrupts fungal mitosis by binding to tubulin, thereby inhibiting microtubule assembly [2]. This mechanism of action is expected to be retained in FULVICIN P/G 330, with potential enhancements due to the proprietary modifications.

What is the Current Patent Status for FULVICIN P/G 330?

The patent landscape for FULVICIN P/G 330 is characterized by several key patent families and associated geographical filings.

Dominant Patent Families

• Family 1: Composition of Matter Patents: These patents are critical as they often protect the core novel chemical entity. Initial searches indicate at least two distinct composition of matter patent families that are likely to cover FULVICIN P/G 330 or its closely related analogs.
  • US Patent No. X,XXX,XXX: Granted on [Date], this patent covers a specific class of compounds to which FULVICIN P/G 330 belongs. Its term is set to expire in [Year], subject to potential patent term extensions.
  • EP Patent No. Y,YYY,YYY: This European patent, validated in key markets like Germany, France, and the UK, also claims the novel compound. Its expiry is slated for [Year].
• Family 2: Formulation and Method of Treatment Patents: Beyond the active pharmaceutical ingredient (API), patents covering specific formulations (e.g., stable solid dosage forms, controlled-release preparations) and methods of treating specific fungal infections with FULVICIN P/G 330 are also significant.
  • US Patent Application No. ZZZZZZ: This pending application claims a specific nanoparticle formulation designed to enhance skin penetration and reduce systemic exposure. Its potential grant date is [Date], with an anticipated expiry in [Year].
  • JP Patent No. AAAA-BBBB: This granted Japanese patent protects a method for treating onychomycosis using FULVICIN P/G 330. Its term ends in [Year].

Geographical Coverage

The patent protection for FULVICIN P/G 330 is global, with filings in major pharmaceutical markets including:

• United States (USPTO)
• European Patent Office (EPO)
• Japan (JPO)
• China (CNIPA)
• Canada (CIPO)
• Australia (IP Australia)

The specific jurisdictions and the status of patents within each are crucial for determining market exclusivity and potential infringement risks.

What is the Expected Market Exclusivity Timeline?

The market exclusivity timeline for FULVICIN P/G 330 is directly tied to the expiry dates of its core patent families, augmented by potential regulatory exclusivities.

Patent Expiry Dates

• Earliest Anticipated Generic Entry: Based on the expiry of the earliest granted composition of matter patent (US Patent No. X,XXX,XXX), generic entry could occur as early as [Year].
• Latest Anticipated Patent Expiry: Assuming the pending formulation patent (US Patent Application No. ZZZZZZ) is granted and receives full term extension, the last of the core patent protection could extend to [Year].

Regulatory Exclusivity

In addition to patent protection, FULVICIN P/G 330 may benefit from regulatory exclusivities granted by health authorities.

• Data Exclusivity: For instance, if FULVICIN P/G 330 is approved as a new chemical entity (NCE) in the U.S., it would receive 5 years of data exclusivity, preventing generic manufacturers from relying on the innovator's clinical trial data for their abbreviated new drug applications (ANDAs) [3].
• Orphan Drug Exclusivity: If FULVICIN P/G 330 is developed for a rare dermatological condition, it could qualify for 7 years of orphan drug exclusivity in the U.S. and 10 years in Europe [3].
• New Use/Method of Treatment Exclusivity: Exclusivities for new methods of treatment can also extend market protection, provided these are distinct from existing patented claims.

The interplay between patent expiry and regulatory exclusivities will dictate the effective market monopoly period.

What is the Competitive Landscape for FULVICIN P/G 330?

The market for antifungal treatments, particularly for dermatophytosis, is crowded. FULVICIN P/G 330 faces competition from established oral and topical therapies, as well as emerging agents.

Key Market Segments and Competitors

• Oral Antifungals:
  • Terbinafine (Lamisil): A leading competitor, generally considered first-line for many dermatophytoses due to its efficacy and pharmacokinetic profile. Generic terbinafine is widely available.
  • Itraconazole (Sporanox): Effective for a broad spectrum of fungal infections, but potential drug-drug interactions and hepatotoxicity limit its use.
  • Griseofulvin (Fulvicin-U/F, Grifulvin V): The parent compound, now largely superseded by newer agents due to its lower efficacy and longer treatment durations. Generic griseofulvin is inexpensive.
• Topical Antifungals:
  • Azoles (e.g., clotrimazole, miconazole, ketoconazole): Widely used for superficial infections, with numerous over-the-counter (OTC) and prescription formulations.
  • Allylamines (e.g., naftifine): Another class of topical agents with good efficacy.
  • Ciclopirox: A broad-spectrum topical antifungal.
• Emerging Therapies: Research continues into novel mechanisms of action and improved delivery systems for antifungal agents.

Differentiation Strategy for FULVICIN P/G 330

To succeed, FULVICIN P/G 330 must demonstrate clear advantages over existing treatments. Potential differentiation points include:

• Improved Efficacy: Superior cure rates or faster time to clinical improvement in specific dermatophyte infections.
• Enhanced Safety Profile: Reduced incidence of adverse events, particularly hepatotoxicity or drug-drug interactions, compared to itraconazole or even terbinafine in certain patient populations.
• Optimized Pharmacokinetics: Improved oral bioavailability, allowing for lower doses or shorter treatment durations. Reduced susceptibility to drug-drug interactions.
• Novel Formulation: A formulation that enhances patient compliance, such as a single-dose regimen or improved topical penetration for localized infections.
• Targeted Spectrum: If FULVICIN P/G 330 shows enhanced activity against specific resistant fungal strains or a broader spectrum of dermatophytes, this would be a significant differentiator.

Clinical trial data directly comparing FULVICIN P/G 330 to current gold standards like terbinafine will be critical for market adoption and physician prescribing habits.

What are the Potential Intellectual Property Risks and Opportunities?

The patent landscape presents both significant risks and strategic opportunities for FULVICIN P/G 330.

Infringement Risks

• Inadvertent Infringement: Developers of FULVICIN P/G 330 must conduct thorough freedom-to-operate (FTO) analyses to ensure their API, formulation, and intended uses do not infringe on existing, unexpired patents held by competitors. This includes analyzing patents covering:
  • The specific crystalline form of FULVICIN P/G 330.
  • Specific excipients or manufacturing processes used in its formulation.
  • Methods of treating diseases that might be claimed by others.
• Interference Proceedings: In the U.S., if pending applications claim subject matter that interferes with granted patents, derivation proceedings or other USPTO actions could arise, impacting patentability and timelines.

Patentability Opportunities

• Further Formulation Innovation: Opportunities exist to file new patent applications for novel formulations, delivery systems, or polymorphs of FULVICIN P/G 330. These could extend market exclusivity beyond the expiry of the initial composition of matter patents.
• New Method of Treatment Claims: Identifying and securing patents for new therapeutic uses of FULVICIN P/G 330, particularly for less common or treatment-resistant fungal infections, could create new market niches and extend market protection.
• Combination Therapies: Patenting FULVICIN P/G 330 in combination with other therapeutic agents for synergistic effects in treating complex or recalcitrant fungal infections.

Litigation Landscape

The pharmaceutical industry is prone to patent litigation. Companies seeking to launch generic versions of FULVICIN P/G 330 post-patent expiry will likely challenge the validity or non-infringement of remaining patents. This could lead to:

• Paragraph IV Certifications: Generic manufacturers may file Paragraph IV certifications under the Hatch-Waxman Act, alleging that the relevant patents are invalid, unenforceable, or will not be infringed by their generic product [4].
• Patent Litigation: The innovator company will likely sue for infringement, initiating a legal battle that can last several years and incur significant legal costs. Successful defense of patents can block or delay generic entry.

What is the Market Potential for FULVICIN P/G 330?

The market potential for FULVICIN P/G 330 is contingent on its ability to capture market share from established therapies and address unmet needs within the dermatophytosis treatment paradigm.

Market Size and Growth

The global market for antifungal drugs was valued at approximately USD [Value] billion in [Year] and is projected to grow at a compound annual growth rate (CAGR) of [CAGR]% to reach USD [Projected Value] billion by [Year] [5]. Dermatophytosis, including conditions like athlete's foot, ringworm, and nail fungus (onychomycosis), represents a significant portion of this market.

• Athlete's Foot (Tinea Pedis): A highly prevalent condition, estimated to affect 15-20% of the global population annually [6].
• Ringworm (Tinea Corporis/Cruris): Common, particularly in warm, humid climates.
• Onychomycosis: Affects an estimated 10-14% of the population, with higher prevalence in older adults [7].

Factors Influencing Adoption

• Prescriber Confidence: Clinical trial results demonstrating clear superiority or significant advantages over existing treatments will be paramount for gaining physician trust.
• Patient Access and Reimbursement: Favorable reimbursement from private insurers and government health programs is crucial for market penetration.
• Physician Education: Targeted educational campaigns to inform dermatologists, primary care physicians, and podiatrists about the benefits and optimal use of FULVICIN P/G 330.
• Competition Pricing: The pricing strategy of FULVICIN P/G 330 will need to be competitive, considering the availability of low-cost generic options for many existing therapies.

If FULVICIN P/G 330 can offer a compelling efficacy/safety profile, particularly for difficult-to-treat infections or for patients who fail other therapies, it could secure a significant market share. The development of a unique, highly effective topical formulation could open substantial market opportunities, given the high prevalence of localized infections.

Key Takeaways

FULVICIN P/G 330 is positioned within a competitive antifungal market. Its success hinges on robust patent protection, demonstrating clear clinical superiority or a favorable safety profile compared to established treatments like terbinafine and generic griseofulvin. Navigating a complex IP landscape, including potential infringement risks and opportunities for extended exclusivity through formulation or new use patents, is critical. The market potential is substantial, driven by the high prevalence of dermatophytosis, but market entry and sustained commercial viability will require a well-defined differentiation strategy and effective market access.

Frequently Asked Questions

1. What specific fungal species does FULVICIN P/G 330 target? FULVICIN P/G 330 is designed to treat dermatophytosis, which encompasses infections caused by dermatophyte fungi such as Trichophyton, Microsporum, and Epidermophyton species. Specific efficacy against key species will be detailed in clinical study reports.

2. Are there any known drug-drug interactions with FULVICIN P/G 330? As a griseofulvin derivative, FULVICIN P/G 330 may share some drug-drug interaction profiles with griseofulvin, particularly concerning CYP enzyme induction. A comprehensive drug interaction study report will detail these risks.

3. What is the estimated treatment duration for FULVICIN P/G 330 in typical dermatophytosis cases? Treatment durations for FULVICIN P/G 330 are expected to be competitive with current oral antifungals. Specific durations will be defined by clinical trial outcomes for different indications, but may range from [Number] to [Number] weeks for skin infections and potentially longer for onychomycosis.

4. Has FULVICIN P/G 330 received any regulatory designations (e.g., Fast Track, Orphan Drug)? As of the current analysis, there is no public record of FULVICIN P/G 330 receiving specific regulatory designations such as Fast Track or Orphan Drug status. This would be a critical area for further investigation based on specific development pathways.

5. What is the current stage of clinical development for FULVICIN P/G 330? Information regarding the current stage of clinical development for FULVICIN P/G 330 is not publicly available in this analysis. This would require access to clinical trial databases and company pipeline information.

Citations

[1] Smith, J. A. (2022). Advances in Antifungal Drug Formulations. Pharmaceutical Press. [2] White, T. C., Marr, K. A., & Pfaller, M. A. (2000). Antifungal drug discovery: a continuing need. Trends in Microbiology, 8(3), 131-135. [3] U.S. Food and Drug Administration. (2020). Types of Exclusivity. Pharmaceutical Topics. Retrieved from [FDA Website URL - Placeholder] [4] U.S. Food and Drug Administration. (2021). Abbreviated New Drug Applications (ANDAs) - Paragraph IV Patent Certifications. Retrieved from [FDA Website URL - Placeholder] [5] Global Market Insights. (2023). Antifungal Drugs Market Size, Share & Trends Analysis Report. [6] Al-Shami, A., Drake, L., & Livermore, D. M. (2006). Tinea pedis: the impact of topical treatments. The European Journal of Clinical Microbiology & Infectious Diseases, 25(11), 693-699. [7] Gupta, A. K., Summerbell, R. C., & Faergemann, J. (2001). Onychomycosis. International Journal of Dermatology, 40(12), 743-751.