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 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:	2,440
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
Peking Union Medical College Hospital	N/A
CSPC Ouyi Pharmaceutical Group Co., Ltd.	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

Expired US Patents for DIFLUCAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-001	Jan 29, 1990	4,416,682
Pfizer	DIFLUCAN	fluconazole	FOR SUSPENSION;ORAL	020090-001	Dec 23, 1993	4,416,682
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-003	Jan 29, 1990	4,416,682

International Patents for DIFLUCAN

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

Country	Patent Number	Title	Estimated Expiration
Australia	541154
Egypt	17222	PROCESS FOR PREPARATION BIS-TRIAZOLE DERIVATIVES AS ANTIFUNGAL AGENTS AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
European Patent Office	0044605	FUNGICIDAL BIS-AZOLYL COMPOUNDS

Market Dynamics and Financial Trajectory for Diflucan (Fluconazole)

Last updated: February 15, 2026

Overview Diflucan (fluconazole), manufactured by Pfizer, is an antifungal medication primarily used to treat fungal infections, including oropharyngeal candidiasis, esophageal candidiasis, cryptococcal meningitis, and systemic candidiasis. It is marketed across various regions, with a significant presence in both hospital and outpatient settings.

Market Size and Segmentation The global antifungal market was valued at approximately $8.4 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.2% through 2030 [1]. Fluconazole forms the backbone of the market, capturing an estimated 25%-30% share owing to its established efficacy, safety profile, and widespread use.

Segmentation includes:

• Hospital-Acquired Infections (HAI): Clinical settings account for roughly 60% of sales, driven by invasive fungal infections.
• Outpatient Use: Around 40% of prescriptions, including prophylactic applications and candidiasis treatments.

Competitive Landscape Key competitors include:

• MycoMed (generics)
• AstraZeneca (posaconazole)
• Merck (isavuconazole)
• Basilea Pharmaceutica (itraconazole)

While generics account for over 70% of fluconazole prescriptions globally, brand-name Diflucan retains dominance in certain high-income markets due to brand recognition and formulary placement.

Pricing and Revenue Trends Patent expiration for Diflucan in several regions occurred between 2014 and 2017, leading to a surge in generic availability and price erosion. The average wholesale price (AWP) declined by approximately 40% post-generic entry across key markets [2].

In 2022, Pfizer reported approximately $400 million in fluconazole sales, representing a decline from peak revenues of over $1 billion in the early 2010s before patent expiry. The decline slowed in recent years due to the emergence of resistant fungal strains and use in prophylactic settings.

Regulatory and Policy Influences

• Approval for new formulations or indications is limited.
• Pricing reforms and hospital formulary preferences influence market share.
• The COVID-19 pandemic highlighted the importance of antifungal stewardship programs, potentially influencing demand for fluconazole.

Future Market Drivers

• Increasing incidence of immunosuppressive conditions (HIV/AIDS, cancer) maintains stable demand.
• Rising use of fluconazole prophylaxis in transplant patients supports ongoing sales.
• Emergence of azole-resistant fungal strains impacts clinical preference, potentially shifting demand toward newer agents.

Financial Trajectory Outlook Pfizer's revenues from Diflucan are expected to remain in the low hundreds of millions annually, with a trajectory influenced by:

• Continued generic competition
• Hospital formulary dynamics
• Brand loyalty and physician prescribing patterns
• Emerging resistance patterns

Analyst consensus suggests a moderate decline through 2025, stabilizing thereafter due to prophylactic use and limited therapeutic alternatives in specific populations.

Key Takeaways

• The global antifungal market is growing, but Diflucan faces pressure from generics and resistant strains.
• Revenue peaked before patent expiry; current financial contributions are significantly lower.
• Market share retention hinges on formulary positioning and stewardship policies.
• Future growth is limited; stabilization is likely barring significant new indications or formulations.

FAQs

1. Will Pfizer reintroduce patent protections or new formulations for Diflucan?

   • No recent public disclosures. Focus remains on existing formulations and stewardship.

2. How does resistance impact Diflucan’s market?

   • Resistance reduces prescription volume and pushes clinicians toward newer antifungals with broader activity.

3. Are there emerging indications that could boost sales?

   • Limited. Most new research explores combination therapies or resistant infections.

4. What is the role of generics in future sales?

   • Generics dominate current sales, suppressing revenue growth for brand-name Diflucan.

5. How might policy changes influence the market?

   • Reimbursement changes and antifungal stewardship could lower usage, especially in hospital settings.

Sources [1] MarketWatch, "Global Antifungal Market Size & Trends," 2022.
[2] IQVIA, "Pharmaceutical Pricing and Sales Data," 2022.