FLUCONAZOLE - Generic Drug Details

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

Fluconazole is the generic ingredient in eight branded drugs marketed by Pfizer, Aurobindo Pharma, Hikma, Ivax Sub Teva Pharms, Sun Pharm Inds Ltd, Taro Pharm Inds, Zhejiang Poly Pharm, Hikma Farmaceutica, Hospira, Pharmobedient, Woodward, Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, Baxter Hlthcare, Inforlife, Mylan Labs Ltd, Ani Pharms, Chartwell, Dr Reddys Labs Inc, Gedeon Richter Usa, Glenmark Pharms Ltd, Lupin Ltd, Mylan Pharms Inc, Pliva, Ranbaxy Labs Ltd, Roxane, Taro, Teva, Thinq Pharm-cro Pvt, and Zydus Pharms, and is included in forty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for fluconazole. Forty-four suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for FLUCONAZOLE

US Patents:	0
Tradenames:	8
Applicants:	31
NDAs:	45
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	44
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	291
Patent Applications:	7,525
Drug Prices:	Drug price trends for FLUCONAZOLE
Drug Sales Revenues:	Drug sales revenues for FLUCONAZOLE
What excipients (inactive ingredients) are in FLUCONAZOLE?	FLUCONAZOLE excipients list
DailyMed Link:	FLUCONAZOLE at DailyMed

See drug prices for FLUCONAZOLE

See drug sales revenues for FLUCONAZOLE

Recent Clinical Trials for FLUCONAZOLE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Melinta Therapeutics	PHASE3
Fernanda P Silveira, MD, MS	PHASE3
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal	PHASE4

See all FLUCONAZOLE clinical trials

Generic filers with tentative approvals for FLUCONAZOLE

Applicant	Application No.	Strength	Dosage Form
		200MG	TABLET;ORAL
		150MG	TABLET;ORAL
		100MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for FLUCONAZOLE

Drug Class	Azole Antifungal
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A4 Inhibitors

Medical Subject Heading (MeSH) Categories for FLUCONAZOLE

14-alpha Demethylase Inhibitors

Antifungal Agents

Cytochrome P-450 CYP2C19 Inhibitors

Cytochrome P-450 CYP2C9 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for FLUCONAZOLE

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

J02AC	Triazole and tetrazole derivatives
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for FLUCONAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Inforlife	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	fluconazole	INJECTABLE;INJECTION	079104-002	Jul 30, 2009	AP	RX	No	Yes
Lupin Ltd	FLUCONAZOLE	fluconazole	TABLET;ORAL	209146-004	Oct 20, 2023		DISCN	No	No
Hikma	FLUCONAZOLE	fluconazole	FOR SUSPENSION;ORAL	076246-002	Jul 29, 2004		DISCN	No	No
Pliva	FLUCONAZOLE	fluconazole	TABLET;ORAL	076424-003	Jul 29, 2004		DISCN	No	No
Teva	FLUCONAZOLE	fluconazole	TABLET;ORAL	074681-002	Jul 29, 2004		DISCN	No	No

Expired US Patents for FLUCONAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-003	Jan 29, 1990	4,404,216*PED
Pfizer	DIFLUCAN IN SODIUM CHLORIDE 0.9%	fluconazole	INJECTABLE;INJECTION	019950-001	Jan 29, 1990	4,404,216*PED
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-004	Jun 30, 1994	4,404,216*PED
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-001	Jan 29, 1990	4,416,682
Pfizer	DIFLUCAN	fluconazole	FOR SUSPENSION;ORAL	020090-001	Dec 23, 1993	4,404,216*PED

Market Dynamics and Financial Trajectory for Fluconazole

Last updated: July 27, 2025

Introduction

Fluconazole, a triazole antifungal agent developed by Pfizer in the 1980s, remains a cornerstone in the treatment of systemic fungal infections. Its broad-spectrum efficacy, favorable safety profile, and oral bioavailability have sustained its prominence in infectious disease management. As of 2023, the drug’s market landscape has experienced significant shifts driven by emerging resistance patterns, evolving diagnostic protocols, and increasing global healthcare expenditures. This article explores the current market dynamics and financial trajectory of fluconazole, emphasizing regulatory, commercial, and technological factors influencing its future.

Market Overview

Global Demand and Usage Patterns

Fluconazole commands a considerable segment within the antifungal therapeutics market, expected to reach USD 2.5 billion by 2025, growing at a Compound Annual Growth Rate (CAGR) of approximately 4% (source: MarketsandMarkets). Predominantly prescribed for candidiasis, cryptococcal meningitis, and systemic fungal infections, fluconazole benefits from widespread adoption in hospitals, outpatient clinics, and global health programs.

The drug’s utilization remains high in regions with elevated infectious disease burdens, such as Africa, Southeast Asia, and parts of Latin America, where infectious diseases pose substantial health challenges. The rise in immunocompromised populations—HIV/AIDS patients, transplant recipients, and cancer patients—further enhances demand.

Competitive Landscape

The pharmaceutical market includes several key players in fluconazole production. Pfizer’s original formulation remains dominant; however, generic manufacturers have captured significant market share following patent expiry in multiple jurisdictions (notably in the U.S. and Europe). The entrance of generics has driven down prices, increasing accessibility but exerting pricing pressure on branded formulations.

Emerging alternatives, such as newer azoles like voriconazole and isavuconazole, have slightly shifted prescribing patterns toward broader-spectrum agents or those with enhanced efficacy against resistant strains. Nonetheless, fluconazole’s cost-effectiveness sustains its essential role.

Market Drivers

Growing Infectious Disease Burden

The global rise in fungal infections, particularly among immunocompromised patients, boosts fluconazole demand. Notably, cryptococcal meningitis remains a significant cause of mortality in HIV-positive populations, with fluconazole serving as both treatment and prophylaxis tool (WHO reports).

Healthcare Infrastructure Expansion

Developing countries investing in healthcare infrastructure foster increased antifungal use. Improved diagnostic capabilities enable early detection of fungal infections, promoting timely fluconazole treatment.

Cost Advantage and Oral Administration

Fluconazole’s oral formulation, broad availability, and low-cost production make it a preferred choice in resource-limited settings, reinforcing its market dominance.

Regulatory and Patent Landscape

Patent expirations in major markets have facilitated price competition, expanding access and volume. Regulatory approvals for generic equivalents and supportive inclusion in WHO Essential Medicines List maintain its global relevance.

Market Challenges

Antifungal Resistance

The emergence of fluconazole-resistant strains of Candida albicans and other fungi presents a critical challenge. Resistance rates vary globally, with higher prevalence linked to prior antifungal exposure and prolonged therapy. This resistance diminishes fluconazole’s efficacy, prompting clinicians to consider alternative agents and complicate treatment protocols.

Adverse Effects and Limitations

While generally well tolerated, fluconazole’s potential for hepatotoxicity and drug-drug interactions, especially in polypharmacy contexts, limits its use in certain populations. This may impact prescribing habits and market share projections.

Availability of Advanced Alternatives

The advent of newer triazoles with broader spectra, enhanced pharmacokinetics, and better resistance profiles (e.g., voriconazole, posaconazole) influences prescribing decisions.

Regulatory and Patent Outlook

Major markets like the U.S. and EU saw patent expirations in the late 2000s, leading to an influx of generics. Patent protections for formulation improvements or specific indications in certain jurisdictions could influence future market exclusivity. Intellectual property strategies remain pivotal for pharmaceutical companies aiming to prolong product lifecycle.

Financial Trajectory

Revenue Trends

In the short to medium term, fluconazole’s revenues are expected to remain relatively stable, buoyed by continued demand in developing regions and in contexts where cost-effectiveness outweigh newer drugs’ benefits. However, overall growth may plateau due to resistance and competition.

Pricing Dynamics

Generic entries have led to significant price erosion. Nonetheless, branded formulations continue to command premiums in specific markets—particularly where regulatory or supply chain complexities restrict access to generics.

Strategic Opportunities

Investments in formulation improvements, such as intravenous-to-oral switches, and development of combination therapies could unlock incremental revenues. Furthermore, expanding indications, including prophylactic uses in high-risk populations, offers growth avenues.

Emerging Markets

Increasing healthcare expenditure and expanding diagnostic capacities in Asia-Pacific and Africa are prospects for revenue growth. The global initiative to improve antifungal access aligns with fluconazole’s cost-effective profile.

Future Outlook and Trends

The future of fluconazole hinges on resistance management, evolving clinical guidelines, and technological innovations in diagnostics. Precision medicine approaches, including susceptibility testing, could optimize usage and preserve efficacy. Additionally, pharmaceutical companies may focus on developing novel formulations or delivery mechanisms to extend product life cycles.

Despite formidable challenges, fluconazole retains its vital role, especially where affordability and accessibility are critical. Strategic investments in research to circumvent resistance mechanisms and ongoing patent strategies will be decisive in shaping its market trajectory.

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Key Takeaways

• Persistent Dominance: Fluconazole remains a fundamental antifungal agent, especially in resource-limited settings, due to its cost-effectiveness and broad-spectrum activity.
• Market Growth: Global antifungal markets project moderate growth driven by increased infectious disease burdens and healthcare infrastructure expansion.
• Resistance Threats: Rising antifungal resistance poses a significant threat to fluconazole’s effectiveness, demanding vigilant stewardship and development of alternatives.
• Regulatory Impact: Patent expirations have catalyzed generic proliferation, resulting in price reductions but intensifying competition.
• Strategic Opportunities: Innovation in formulations, expanding indications, and targeting emerging markets are crucial for sustaining revenue streams.

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FAQs

1. What are the primary factors influencing fluconazole's market size?
   The primary drivers include the global burden of fungal infections, especially among immunocompromised populations, cost-effectiveness, healthcare infrastructure investments, and regulatory approvals of generics.

2. How does antifungal resistance impact fluconazole’s market prospects?
   Resistance reduces clinical efficacy, leading clinicians to favor alternative agents. It prompts investment in resistance monitoring and development of novel antifungals, potentially constraining fluconazole’s long-term dominance.

3. What is the role of generic formulations in the fluconazole market?
   Generics significantly lower product costs, expanding access in developing nations. They account for a large share of sales post-patent expiry, although they exert downward pressure on prices.

4. Are there opportunities for expanding fluconazole indications?
   Yes, prophylactic use in high-risk populations and combination therapies are potential avenues. Enhanced diagnostics can also facilitate targeted therapy, broadening clinical applications.

5. What are the anticipated trends in fluconazole's pricing and revenue in the next five years?
   Prices are expected to remain low due to generic competition, but revenues may stabilize or slightly decline due to rising resistance. Emerging markets and new formulations may provide growth opportunities.

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References

1. MarketsandMarkets. Antifungal Drugs Market. 2021.
2. World Health Organization. Guidelines for the Diagnosis, Prevention and Management of Cryptococcal Disease in HIV. 2018.
3. Pfister, D. et al. "Antifungal Resistance in Candida albicans." Clinical Microbiology Reviews, 2020.
4. U.S. Food and Drug Administration (FDA). Generic Drug Approvals. 2022.
5. Global Data. Pharmaceutical Markets Analysis. 2022.