Griseofulvin, microsize - Generic Drug Details

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

Griseofulvin, microsize is the generic ingredient in three branded drugs marketed by Valeant Luxembourg, Actavis Mid Atlantic, Chartwell Rx, Cipla, Cosette, Sandoz, and Sigmapharm Labs Llc, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

Seven suppliers are listed for this compound.

Summary for griseofulvin, microsize

US Patents:	0
Tradenames:	3
Applicants:	7
NDAs:	9
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	96
DailyMed Link:	griseofulvin, microsize at DailyMed

Pharmacology for griseofulvin, microsize

Drug Class	Tubulin Inhibiting Agent
Physiological Effect	Decreased Mitosis Microtubule Inhibition

Anatomical Therapeutic Chemical (ATC) Classes for griseofulvin, microsize

D01AA	Antibiotics
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

D01BA	Antifungals for systemic use
D01B	ANTIFUNGALS FOR SYSTEMIC USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

US Patents and Regulatory Information for griseofulvin, microsize

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, microsize	TABLET;ORAL	062279-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Valeant Luxembourg	GRIFULVIN V	griseofulvin, microsize	SUSPENSION;ORAL	062483-001	Jan 26, 1984		DISCN	No	No
Sandoz	GRISEOFULVIN	griseofulvin, microsize	TABLET;ORAL	091592-001	Aug 7, 2013	AB	RX	No	No
Sandoz	GRISEOFULVIN	griseofulvin, microsize	TABLET;ORAL	091592-002	Aug 7, 2013	AB	RX	No	Yes
Cipla	GRISEOFULVIN	griseofulvin, microsize	SUSPENSION;ORAL	065354-001	Sep 10, 2007	AB	RX	No	No
Chartwell Rx	FULVICIN-U/F	griseofulvin, microsize	TABLET;ORAL	060569-002	Approved Prior to Jan 1, 1982	AB	RX	No	No
Cosette	GRISEOFULVIN	griseofulvin, microsize	SUSPENSION;ORAL	065438-001	Oct 8, 2010	AB	RX	No	No

Market Dynamics and Financial Trajectory for GRISEOFULVIN, MICROSIZE

Last updated: February 20, 2026

What is the current market size and growth potential for microsize griseofulvin?

The global antifungal drugs market was valued at approximately USD 14 billion in 2021. Griseofulvin, particularly in microsize formulations, accounts for a small but steady segment within this market, heavily dependent on dermatophytic infection treatment. Microsize formulations improve bioavailability and patient compliance, contributing to their adoption. Industry forecasts project a compound annual growth rate (CAGR) of 5% for antifungal therapies, with a portion attributable to advances in drug delivery like microsizing.

How does the formulation technology influence market adoption?

Microsize formulations of griseofulvin enhance drug dissolution, allowing for lower dosages and improved absorption. This technological advancement reduces adverse effects, such as gastrointestinal discomfort, and extends the drug's applicability. Pharmaceutical companies investing in nanosizing or microsizing recognize improved therapeutic outcomes, increasing market attractiveness. The technical superiority of microsize griseofulvin favors ongoing clinical development and regulatory approvals, fostering product pipeline expansion.

What is the competitive landscape and key players?

Major pharmaceutical companies engaged in antifungal drugs include Pfizer, Novartis, and Teva. Specifically, companies developing or licensing microsize griseofulvin formulations include:

• Novartis: Invests in dermatophytic antifungal therapies, including nanos and microsized formulations.
• GSK: Developed dermatology drugs, emphasizing improved delivery systems.
• Generic firms: Focus on cost-effective microsize formulations for emerging markets.

Patent protections for original formulations expire in the next 5 years, opening opportunities for generic entrants. New players may focus on developing proprietary microsizing processes, such as high-pressure homogenization or wet milling, to differentiate offerings.

What are the key regulatory considerations affecting market entry?

Regulatory approval depends on demonstrating improved bioavailability and safety profiles. Agencies like the FDA and EMA require data from bioequivalence, pharmacokinetic, and clinical efficacy studies. The 505(b)(2) pathway in the US allows abbreviated approval for reformulated versions, potentially accelerating market entry. Regulatory hurdles include proving manufacturing consistency, especially for nanoscale particle size distributions, which are tightly regulated.

How do patent landscapes impact the financial trajectory?

Patents covering the core molecule and formulation methods expire between 2023 and 2028. This expiration opens the market to generic microsize formulations, reducing branded drug revenues. Companies with proprietary manufacturing processes or drug delivery platforms can sustain exclusivity through new patents or exclusivity periods. The enterprising use of patent pathways, such as method-of-use or formulation patents, is critical for maintaining sales momentum.

What are the production and supply chain considerations?

Scaling microsize griseofulvin production involves high-energy milling equipment, spray drying, and complex quality control processes ensuring uniform particle size and stability. Supply chain risks include raw material shortages for excipients and stabilizers, which can delay product launches or reformulation efforts. The cost of manufacturing microsize formulations is higher than traditional forms, influencing pricing strategies.

What is the financial outlook for investments in microsize griseofulvin?

Projected revenues for reformulated microsize griseofulvin are moderate but improving with increasing prescriptions for dermatophyte infections. Investment in R&D can lead to formulations with extended patent life and higher margins. Generic competition pressures are expected to drive prices downward post-patent expiry, but firms with early innovation and a robust pipeline can capitalize on licensing deals and contract manufacturing.

What are the key risks and barriers?

• Regulatory delays: Extended approval processes can impact market entry timelines.
• Manufacturing complexity: Difficulties in quality control may limit scalability.
• Market penetration: Consumer and clinician preferences may favor established brands.
• Patent challenges: Patent expirations can lead to intense generic competition.

Summary Table

Market Aspect	Details
2021 Market Size	USD 14 billion (antifungals)
Forecast CAGR	5%
Patent Expiry (Key patents)	2023-2028 in mature markets
Major Players	Pfizer, Novartis, GSK, generic companies
Regulatory Pathways	FDA 505(b)(2), EMA regulatory procedures
Production Costs	Higher than traditional, due to milling and stabilization
Revenue Potential (Post-Patent)	Declines after 2023, but new formulations sustain income

Key Takeaways

• The microsize formulation enhances bioavailability, supporting clinical benefits and market growth.
• Patent expiry creates price competition post-2023, but proprietary manufacturing can extend exclusive revenues.
• Regulatory pathways favor reformulation approvals, but require thorough bioequivalence data.
• Production complexity and supply chain risks influence market scalability and costs.
• Investment opportunities exist in pipeline development, especially for formulations with novel delivery systems.

FAQs

1. How does microsizing improve griseofulvin performance?
Microsizing reduces particle size, increasing surface area, which enhances dissolution and absorption, leading to higher bioavailability and potentially better therapeutic outcomes.

2. When do key patents for microsize griseofulvin expire?
Patents related to the core formulation are expected to expire between 2023 and 2028, depending on jurisdiction and patent type.

3. What regulatory pathways favor reformulated griseofulvin?
The FDA’s 505(b)(2) pathway allows approval based on existing data, enabling quicker market entry for reformulated versions.

4. How will generic competition affect market prices?
Post-patent expiry, generic microsize formulations will likely reduce prices and market share for branded products.

5. What are the main hurdles in manufacturing microsize formulations?
Manufacturing complexity includes maintaining particle size uniformity, preventing aggregation, and ensuring stability, which increase production costs.

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References

[1] MarketsandMarkets. (2022). Antifungal Drugs Market by Type, Application, and Region.
[2] U.S. Food and Drug Administration. (2022). Bioequivalence Recommendations for Topical and Systemic Drugs.
[3] PatentScope. (2022). Patent expiration dates for antifungal formulations.
[4] Grand View Research. (2021). Antifungal Market Size and Growth.
[5] EMA. (2022). Regulatory guidance for reformulated drugs.