TIOCONAZOLE - Generic Drug Details

What are the generic drug sources for tioconazole and what is the scope of patent protection?

Tioconazole is the generic ingredient in three branded drugs marketed by Pfizer, Perrigo, and Combe, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for tioconazole. Eighteen suppliers are listed for this compound.

Summary for TIOCONAZOLE

US Patents:	0
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	85
Patent Applications:	6,805
Drug Prices:	Drug price trends for TIOCONAZOLE
What excipients (inactive ingredients) are in TIOCONAZOLE?	TIOCONAZOLE excipients list
DailyMed Link:	TIOCONAZOLE at DailyMed

See drug prices for TIOCONAZOLE

Pharmacology for TIOCONAZOLE

Drug Class

Azole Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for TIOCONAZOLE

D01AC	Imidazole and triazole derivatives
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

G01AF	Imidazole derivatives
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for TIOCONAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	TZ-3	tioconazole	CREAM;TOPICAL	018682-001	Feb 18, 1983		DISCN	No	No
Combe	VAGISTAT-1	tioconazole	OINTMENT;VAGINAL	020676-001	Feb 11, 1997		OTC	Yes	Yes
Perrigo	TIOCONAZOLE	tioconazole	OINTMENT;VAGINAL	075915-001	Nov 21, 2001		OTC	No	No

Expired US Patents for TIOCONAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	TZ-3	tioconazole	CREAM;TOPICAL	018682-001	Feb 18, 1983
Pfizer	TZ-3	tioconazole	CREAM;TOPICAL	018682-001	Feb 18, 1983

TIOCONAZOLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tioconazole

Introduction to Tioconazole

Tioconazole is an imidazole antifungal agent widely used to treat various fungal and yeast infections, including vulvovaginal candidiasis (VVC), ringworm, jock itch, athlete's foot, and tinea versicolor. Here, we will delve into the market dynamics and financial trajectory of tioconazole, highlighting its position within the broader antifungal drugs market.

Global Antifungal Drugs Market Overview

The global antifungal drugs market is experiencing significant growth driven by several key factors. The market was estimated at $16.5 billion in 2023 and is projected to reach $22 billion by 2030, growing at a CAGR of 4.2% from 2023 to 2030[3].

Segmentation and Market Share

Drug Class

Tioconazole falls under the azoles drug class, which is one of the dominant segments in the antifungal market. The azoles segment is expected to reach $10.7 billion by 2030, growing at a CAGR of 4.5% during the forecast period[3].

Route of Administration

Tioconazole is available in both topical and oral formulations. The topical segment, while not as dominant as the oral segment, is expected to grow steadily. Topical antifungals like tioconazole are used for conditions such as ringworm, jock itch, and athlete's foot, and they also play a role in treating VVC[1].

Regional Analysis

North America

North America, particularly the U.S., is a significant market for antifungal drugs, including tioconazole. This region dominated the global VVC treatment market in 2021, accounting for more than 37.50% of the overall revenue. The high disease prevalence, increased healthcare expenditure, and presence of major players contribute to this dominance[1].

Asia Pacific

The Asia Pacific region is expected to witness the fastest growth rate over the forecast period. Factors such as rising disease burden, increasing testing rates, and improved healthcare benefits by governments are driving growth in this region. This trend is likely to benefit tioconazole and other antifungal drugs[1].

Market Drivers

Increasing Prevalence of Fungal Infections

The rising incidence of fungal infections, particularly among immunocompromised individuals and the elderly, is a major driver for the antifungal drugs market. VVC, for instance, affects around 138 million women annually worldwide, with nearly 75% of women experiencing the disease at least once in their lifetime[1].

Technological Advancements and New Drug Approvals

Advances in antifungal drug formulations and delivery systems, such as the recent approvals of therapies like BREXAFEMME and VIVJOA, are enhancing treatment efficacy and patient adherence. These advancements are crucial for the growth of the market, including the segment that includes tioconazole[1].

Prophylactic Use in High-Risk Populations

The trend of prophylactic antifungal use in high-risk populations is also propelling market growth. This includes the use of antifungals like tioconazole in patients who are more susceptible to fungal infections due to compromised immune systems[3].

Financial Trajectory

Revenue Forecast

The global VVC treatment market, which includes tioconazole, was valued at $986.5 million in 2021 and is expected to grow at a CAGR of 4.39% from 2022 to 2030, reaching $1.64 billion by 2030[1].

Segment Revenue

The fluconazole segment, which is closely related to tioconazole in terms of therapeutic use, accounted for a significant share of 45.74% in 2021. While specific revenue figures for tioconazole are not provided, its inclusion in the broader azoles segment suggests a substantial contribution to the overall market revenue[1].

Competitive Landscape

Tioconazole competes with other antifungal agents such as clotrimazole, nystatin, fluconazole, and terconazole. Major players in the antifungal market include Abbott Laboratories, Inc., Bayer AG, Gilead Sciences, Inc., and Pfizer, Inc. These companies are continuously investing in research and development to enhance their product portfolios and market positions[3].

Key Insights and Trends

• Efficacy and Convenience: Tioconazole's broad-spectrum antifungal activity and its availability in both topical and oral formulations make it a preferred choice for treating various fungal infections.
• Regulatory Approvals: Recent approvals of new antifungal therapies and the integration of antifungal drugs into comprehensive care plans for chronic diseases are driving market growth.
• Healthcare Awareness: Increasing awareness of fungal infections and improved diagnostic techniques are leading to earlier and more accurate diagnoses, thereby increasing demand for effective treatments like tioconazole[3].

Challenges and Opportunities

• Resistance and Side Effects: The development of resistance to antifungal drugs and potential side effects are challenges that the market faces. However, innovations in genomics and molecular biology are generating new market opportunities for more targeted and effective treatments.
• Emerging Markets: The Asia Pacific and Middle East & Africa regions offer significant growth opportunities due to their rising disease burdens and improving healthcare infrastructure[3].

Key Takeaways

• Tioconazole is a key player in the antifungal drugs market, particularly in the treatment of VVC and other fungal infections.
• The global antifungal drugs market is driven by increasing prevalence of fungal infections, technological advancements, and new drug approvals.
• The Asia Pacific region is expected to witness the fastest growth rate, driven by rising disease burden and improving healthcare infrastructure.
• Tioconazole's broad-spectrum activity and convenience in administration contribute to its market share within the azoles segment.

Frequently Asked Questions (FAQs)

Q: What is the primary use of tioconazole? A: Tioconazole is primarily used to treat fungal and yeast infections, including vulvovaginal candidiasis, ringworm, jock itch, athlete's foot, and tinea versicolor.

Q: How does tioconazole work? A: Tioconazole inhibits the growth of fungal organisms by interfering with the production of ergosterol, an essential component of the yeast membrane, thereby increasing cellular permeability[5].

Q: What is the market size of the global antifungal drugs market? A: The global antifungal drugs market was estimated at $16.5 billion in 2023 and is projected to reach $22 billion by 2030[3].

Q: Which region is expected to grow the fastest in the antifungal drugs market? A: The Asia Pacific region is expected to witness the fastest growth rate over the forecast period due to rising disease burden and improving healthcare infrastructure[1].

Q: What are the key drivers of the antifungal drugs market? A: Key drivers include the increasing prevalence of fungal infections, technological advancements, new drug approvals, and the trend of prophylactic antifungal use in high-risk populations[3].

Cited Sources:

1. Grand View Research: Vulvovaginal Candidiasis Treatment Market Size Report, 2030.
2. Geisinger: P&T Committee Meeting Minutes Commercial, Exchange, CHIP May 2023.
3. GlobeNewswire: Antifungal Drugs Strategic Business Report 2024-2030.
4. ResearchNester: Candidiasis Drugs Market Size & Share, Forecast Report 2036.
5. DrugBank: Tioconazole: Uses, Interactions, Mechanism of Action.