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
Patent Applications:	7,529
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
Cipla	GRISEOFULVIN	griseofulvin, microsize	SUSPENSION;ORAL	065354-001	Sep 10, 2007	AB	RX	No	No
Cosette	GRISEOFULVIN	griseofulvin, microsize	SUSPENSION;ORAL	065438-001	Oct 8, 2010	AB	RX	No	No
Valeant Luxembourg	GRIFULVIN V	griseofulvin, microsize	SUSPENSION;ORAL	062483-001	Jan 26, 1984		DISCN	No	No
Chartwell Rx	FULVICIN-U/F	griseofulvin, microsize	TABLET;ORAL	060569-001	Approved Prior to Jan 1, 1982	AB	RX	No	No
Sandoz	GRISEOFULVIN	griseofulvin, microsize	TABLET;ORAL	091592-001	Aug 7, 2013	AB	RX	No	No

GRISEOFULVIN, MICROSIZE Market Analysis and Financial Projection Experimental

Griseofulvin Market Dynamics and Financial Trajectory

Introduction to Griseofulvin

Griseofulvin is an antibiotic fungistatic drug used orally in the treatment of dermatophyte and ringworm infections. It was the first available oral agent for treating dermatophytoses and is effective against various species of Trichophyton, Microsporum, and Epidermophyton[4].

Market Growth Drivers

The griseofulvin market is anticipated to experience significant growth driven by several key factors:

Increase in Fungal Infections

The rise in cases of dermatophytosis, particularly post-COVID-19 treatment, is a major driver. Patients who have recovered from COVID-19 often have weakened immunity, making them more susceptible to fungal infections, which in turn boosts the demand for griseofulvin[1].

Rising Geriatric Population

The globally increasing geriatric population contributes to the high prevalence of dermatophytosis, as the immune system weakens with age. This demographic shift is expected to drive the growth of the griseofulvin market[1].

Lifestyle and Hospital-Acquired Diseases

A sedentary lifestyle and the increase in hospital-acquired diseases have resulted in a higher rate of dermatophytosis, further driving the market growth[1].

Market Segmentation

The griseofulvin market is segmented based on several criteria:

By Type

Griseofulvin is available in microsize and ultramicrosize preparations. The ultramicrosize form has a higher efficiency of gastrointestinal absorption compared to the microsize form, although this does not significantly impact clinical efficacy[5].

By Application

Griseofulvin is primarily used in the treatment of tinea infections (ringworm) of the skin, hair, and nails, including tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, and tinea unguium (onychomycosis)[4].

By End User

The market is segmented by end users such as hospitals, clinics, and retail pharmacies. The demand from these sectors is driven by the increasing incidence of fungal infections[3].

By Region

The global griseofulvin market is segmented into regions such as North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America. Each region has its own growth dynamics influenced by local healthcare infrastructure, awareness of fungal infections, and economic factors[3].

Key Market Players

Several pharmaceutical companies are active in the griseofulvin market, including:

• GlaxoSmithKline Plc.
• Dr. Reddy’s Laboratories
• CFL Pharmaceuticals Limited
• Inga Pharmaceuticals
• Sun Pharmaceuticals
• Nippon Kayaku
• BAL Pharma Ltd
• Pfizer
• Comed Chemicals Limited[1][3].

These companies are focusing on strategies to strengthen their product portfolios and expand their business globally.

Financial Trajectory

Market Size and Growth Rate

The global griseofulvin market is expected to witness significant growth from 2024 to 2031, driven by the increasing demand for antifungal treatments. The market size is estimated to grow at a compound annual growth rate (CAGR) of several percent during this period[3].

Revenue Generation

Griseofulvin generates the highest revenue in the treatment of tinea capitis, followed by other fungal infections. The revenue is also influenced by the type of formulation, with ultramicrosize preparations showing higher efficiency and potentially higher market share[1].

Regional Performance

The Asia-Pacific region is expected to be a significant contributor to the global griseofulvin market due to its large population, increasing healthcare expenditure, and rising awareness of fungal infections. Other regions, such as North America and Europe, also show promising growth due to advanced healthcare systems and higher demand for antifungal treatments[3].

Challenges and Restraints

Despite the growth potential, the griseofulvin market faces several challenges:

Lack of Awareness

Limited awareness about dermatophytosis and related fungal diseases, as well as treatment options, hampers market growth. Patient reluctance to seek treatment for fungal infections is another significant restraint[1].

Competitive Landscape

Griseofulvin faces competition from newer antifungal drugs like terbinafine and itraconazole, which have broader spectrums of activity and higher efficacy rates. Griseofulvin's fungistatic nature and limited affinity for keratin make it less competitive in some cases[1].

Research and Development

Investments in the R&D sector are crucial for the griseofulvin market. Potential activities and new formulations could enhance the drug's efficacy and market position. Companies are focusing on improving the manufacturing process and exploring new applications to maintain market competitiveness[1][3].

Regulatory Environment

Griseofulvin is registered for human use in various countries and is subject to regulatory standards set by pharmacopeias such as the European Pharmacopoeia and the US Pharmacopeia. Compliance with these regulations is essential for market approval and continued sales[2].

Key Takeaways

• The griseofulvin market is driven by increasing cases of fungal infections, a rising geriatric population, and lifestyle factors.
• The market is segmented by type, application, end user, and region.
• Key players are focusing on strengthening their product portfolios and expanding globally.
• Despite growth potential, the market faces challenges such as lack of awareness and competition from newer drugs.
• R&D investments are crucial for enhancing the drug's efficacy and market position.

FAQs

What are the primary uses of griseofulvin?

Griseofulvin is primarily used in the treatment of tinea infections (ringworm) of the skin, hair, and nails, including tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, and tinea unguium (onychomycosis)[4].

How does griseofulvin work?

Griseofulvin is fungistatic and works by inhibiting fungal cell mitosis and nuclear acid synthesis. It binds to and interferes with the function of spindle and cytoplasmic microtubules, rendering the keratin resistant to fungal invasion[4].

What are the key drivers of the griseofulvin market?

The key drivers include an increase in fungal infection cases post-COVID-19 treatment, a rising geriatric population, and lifestyle factors such as a sedentary lifestyle and hospital-acquired diseases[1].

Which regions are expected to contribute significantly to the griseofulvin market?

The Asia-Pacific region, along with North America and Europe, is expected to be a significant contributor to the global griseofulvin market due to factors such as large population, increasing healthcare expenditure, and rising awareness of fungal infections[3].

What are the main challenges facing the griseofulvin market?

The main challenges include lack of awareness about dermatophytosis and related fungal diseases, patient reluctance to seek treatment, and competition from newer antifungal drugs with broader spectrums of activity[1].

Sources:

1. Allied Market Research - Griseofulvin Market Size & Growth | Analysis & Forecast 2030
2. IARC Publications - GRISEOFULVIN 1. Exposure Data
3. Cognitive Market Research - Global Griseofulvin Market Report 2024 Edition
4. PharmaCompass - GRISEOFULVIN, ULTRAMICROSIZE
5. FDA - Gris-PEG® (griseofulvin ultramicrosize) tablets, USP 125 mg