DIFLUCAN Drug Patent Profile

Which patents cover Diflucan, and when can generic versions of Diflucan launch?

Diflucan is a drug marketed by Pfizer and is included in three NDAs.

The generic ingredient in DIFLUCAN is fluconazole. There are twenty-three drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the fluconazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Diflucan

A generic version of DIFLUCAN was approved as fluconazole by CHARTWELL on July 29^th, 2004.

Summary for DIFLUCAN

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	40
Patent Applications:	4,460
Drug Prices:	Drug price information for DIFLUCAN
What excipients (inactive ingredients) are in DIFLUCAN?	DIFLUCAN excipients list
DailyMed Link:	DIFLUCAN at DailyMed

See drug prices for DIFLUCAN

See drug sales revenues for DIFLUCAN

Recent Clinical Trials for DIFLUCAN

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

Sponsor	Phase
CSPC Ouyi Pharmaceutical Group Co., Ltd.	N/A
Peking Union Medical College Hospital	N/A
Maastricht University Medical Center	Phase 3

See all DIFLUCAN clinical trials

Pharmacology for DIFLUCAN

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

US Patents and Regulatory Information for DIFLUCAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	DIFLUCAN	fluconazole	FOR SUSPENSION;ORAL	020090-001	Dec 23, 1993	AB	RX	Yes	No
Pfizer	DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER	fluconazole	INJECTABLE;INJECTION	019950-003	Sep 29, 1992		DISCN	Yes	No
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-002	Jan 29, 1990	AB	RX	Yes	No
Pfizer	DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	fluconazole	INJECTABLE;INJECTION	019950-004	Jan 29, 1990		DISCN	Yes	No
Pfizer	DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER	fluconazole	INJECTABLE;INJECTION	019950-005	Jul 8, 1994		DISCN	Yes	No

Expired US Patents for DIFLUCAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-002	Jan 29, 1990
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-003	Jan 29, 1990
Pfizer	DIFLUCAN	fluconazole	FOR SUSPENSION;ORAL	020090-001	Dec 23, 1993
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-002	Jan 29, 1990
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-004	Jun 30, 1994

International Patents for DIFLUCAN

See the table below for patents covering DIFLUCAN around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	131535
Denmark	158516
Singapore	46987
Czechoslovakia	228931	METHOD OF PREPARING 2-/2,4-DIFLUOROPHENYL/-1,3-BIS/1H-1,2,4-TRIAZOL-1-YL/PROPAN-2-OL
Hungary	189978	FUNGICIDE AND PLANT GROWTH REGULATING COMPOSITIONS CONTAINING TRIAZOLE AND IMIDAZOLE DERIVATIVES AS ACTIVE SUBSTANCES

Market Dynamics and Financial Trajectory for Diflucan (Fluconazole)

Last updated: August 6, 2025

Introduction

Diflucan, the brand name for fluconazole, is a critical antifungal medication developed by Pfizer. Since its initial approval in 1990, Diflucan has become a mainstay in treating fungal infections, including candidiasis, cryptococcal meningitis, and systemic fungal infections. Its market presence and financial trajectory are shaped by evolving clinical needs, competitive dynamics, regulatory landscapes, and emerging biomedical innovations. This report examines these factors to delineate the current market landscape and project future financial prospects.

Pharmacological Profile and Market Position

Diflucan functions as an oral and intravenous antifungal agent inhibiting fungal cytochrome P450 enzymes, thereby impeding ergosterol synthesis—an essential component of fungal cell membranes. Its broad spectrum and favorable pharmacokinetics facilitated widespread adoption, particularly in immunocompromised populations such as AIDS patients, cancer patients, and transplant recipients [1].

While generic fluconazole has eroded branded sales since patent expirations, Diflucan remains prominent due to Pfizer’s strategic brand positioning, hospital contracts, and a well-established safety profile [2]. Its versatility across multiple indications and compliance advantages bolster its market resilience.

Market Dynamics

1. Patent Expiration and Generic Competition

Pfizer's patent for Diflucan expired in numerous jurisdictions during the early 2000s, leading to the proliferation of generic formulations. Generic fluconazole commands significant market share owing to lower pricing and comparable efficacy, pressuring branded sales [3]. Nevertheless, Pfizer maintains a foothold through controlled distribution channels, patient familiarity, and clinician advocacy.

2. Market Expansion and New Indications

The growing prevalence of immunosuppressive therapies and HIV/AIDS globally sustains demand for antifungal agents. Additionally, recent investigations into fluconazole’s application in prophylactic contexts and resistant fungal strains could broaden its uses, although robust clinical validation remains pending.

Emerging biopharmaceuticals, including novel antifungal agents and targeted therapies, pose competitive threats. Yet, Diflucan’s established clinical utility ensures it remains a primary choice, especially where cost considerations are crucial.

3. Regional Dynamics and Market Penetration

Developing markets present significant growth potential, driven by increasing diagnosis and treatment of fungal infections. However, local pricing policies, healthcare infrastructure, and regulatory hurdles influence market accessibility. Pfizer’s strategic collaborations and licensing agreements are pivotal in consolidating its regional presence.

4. Regulatory Landscape

Regulatory frameworks around antifungal safety, off-label use, and importation affect market dynamics. Recent approvals for certain indications or formulations can temporarily bolster sales, although regulatory delays or restrictions may hinder growth pathways.

5. Competitive Landscape

Key competitors include newer azoles such as voriconazole and posaconazole, which have broader spectra but higher costs. Echinocandins represent another class targeting invasive candidiasis and aspergillosis, though their intravenous administration limits outpatient use. The competitive landscape influences pricing strategies and formulary decisions.

Financial Trajectory Analysis

1. Historical Revenue Trends

Pfizer’s 2000s reports show an initial peak in Diflucan’s revenues, followed by gradual decline attributable to patent expiries and increasing generic penetration [3]. For instance, in 2009, Diflucan’s global sales peaked at approximately $1.3 billion, but subsequent years saw a steady decrease, reflecting generic erosion.

2. Impact of Patent Expiry and Generics

Patent loss significantly affected revenue streams, as generics priced ~70-80% lower than branded formulations. This shift prompted Pfizer to diversify into combination therapies and biosimilars but limited Diflucan’s standalone revenue growth post-patent expiration.

3. Current Financial Status

Despite revenue erosion, Diflucan maintains steady sales owing to long-term contracts, hospital-based distribution, and persistent clinical demand. Estimates suggest current annual sales linger around $400-500 million globally, primarily in emerging markets and hospital settings [4].

4. Influence of Healthcare Policy and Pricing

Price regulations, healthcare reforms, and reimbursement policies influence revenues. In some regions, mandated price caps or cost-containment measures compress profit margins. Conversely, high-quality service networks and brand loyalty help sustain profits despite generic competition.

5. Future Revenue Projections

Projected sales trajectory suggests continued modest decline over the next 5 years unless new indications, formulations, or strategic initiatives are introduced. However, potential growth in infection rates among aging populations and immunosuppressed patients may stabilize or slightly increase demand.

Emerging Opportunities and Risks

Opportunities

• New Formulations and Indications: Development of topical or combination formulations could reinvigorate sales.
• Biomarker-Guided Therapy: Personalized medicine approaches may expand appropriate use cases.
• Untapped Markets: Expanding access in low- and middle-income countries offers substantial growth prospects.
• Patent Extensions or New Patents: Pfizer may seek to extend exclusivity through formulations or delivery methods.

Risks

• Intensified Competition: Arrival of novel antifungals with superior efficacy or safety profiles could supplant Diflucan.
• Regulatory Challenges: Stringent safety evaluations may limit new indications.
• Resistance Development: Increasing fungal resistance reduces drug efficacy, prompting clinicians to prefer alternative therapies.
• Pricing Pressures: Healthcare reforms targeting drug costs might further diminish profitability.

Conclusion

Diflucan’s market dynamics are characterized by the interplay of patent expirations, generics proliferation, and ongoing clinical demand. While Pfizer’s strategic positioning mitigates some revenue losses, the drug’s future financial trajectory hinges on innovation, regional market expansion, and adaptation to competitive pressures. Continued investment in pipeline development, strategic licensing, and targeted indications could provide growth avenues, albeit the overarching trend suggests a gradual decline in sales absent significant breakthroughs.

Key Takeaways

• Patent expiries considerably reduced Diflucan’s market share post-2000s, replaced increasingly by generic fluconazole formulations.
• Global healthcare needs related to immunosuppression sustain deferential demand, especially in developing regions.
• Competitive pressures from newer antifungals and resistance challenges necessitate strategic diversification.
• Regulatory and pricing policies significantly influence profitability, demanding agile market adaptation.
• Future prospects depend on innovation initiatives, emerging indications, and expanding access in underserved markets.

FAQs

Q1: What factors have most significantly impacted Diflucan’s sales since patent expiration?
A1: Patent expiration led to widespread generic competition, substantially lowering prices and sales. Additionally, emergence of new antifungal agents and resistance issues have influenced market share.

Q2: Are there ongoing efforts to extend Diflucan’s market viability?
A2: Yes. Pfizer explores new formulations, combination therapies, and potential new indications. Additionally, patent strategies around delivery methods may extend exclusivity.

Q3: How does regional drug regulation affect Diflucan’s market presence?
A3: Regulatory restrictions influence approval timelines, permissible indications, and pricing, thus modulating sales potential across different markets.

Q4: What future trends could alter the financial trajectory of Diflucan?
A4: Introduction of novel antifungal agents, resistance patterns, expanded indications, and healthcare policy changes are key factors influencing future sales.

Q5: Is Diflucan’s market position sustainable in the long term?
A5: Sustainable positioning requires strategic innovation and market adaptation. Without significant new developments, declining sales are probable due to generic competition and market saturation.

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Sources:

[1] Rex, J.H., et al. (1994). "Pharmacology and clinical efficacy of fluconazole." Clin Infect Dis.
[2] Pfizer Annual Reports (2021). "Diflucan/Spectrum of Use."
[3] IMS Health Data (2010–2020). "Antifungal Drug Market."
[4] EvaluatePharma, Global Sales Data (2022).