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-six 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:	157
Clinical Trials:	40
Patent Applications:	2,657
Drug Prices:	Drug price information for DIFLUCAN
Drug Sales Revenues:	Drug sales revenues 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	TABLET;ORAL	019949-002	Jan 29, 1990	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 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
Pfizer	DIFLUCAN	fluconazole	FOR SUSPENSION;ORAL	020090-001	Dec 23, 1993	AB	RX	Yes	No
Pfizer	DIFLUCAN	fluconazole	FOR SUSPENSION;ORAL	020090-002	Dec 23, 1993	AB	RX	Yes	Yes

Expired US Patents for DIFLUCAN

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

International Patents for DIFLUCAN

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

Country	Patent Number	Title	Estimated Expiration
Denmark	242581
Finland	71134
Germany	3175752
Hungary	194839	PROCESS FOR PRODUCTION OF DERIVATIVES OF TRIASOLE AND IMIDASOLE AND MEDICAL PREPARATIVES CONTAINING SUCH COMPOUNDS
New Zealand	197136	TRIAZOLE AND IMIDAZOLE COMPOUNDS;FUNGICIDAL AND PLANT GROWTH REGULATING COMPOSITIONS
Norway	158538

Market Dynamics and Financial Trajectory for Diflucan (Fluconazole)

Introduction

Diflucan, known generically as fluconazole, is a widely used antifungal medication, particularly for treating various fungal infections such as candidiasis and cryptococcal meningitis. This article delves into the market dynamics and financial trajectory of Diflucan, providing insights into its current market size, growth prospects, and the factors influencing its demand.

Market Size and Growth Prospects

As of 2023, the global fluconazole market was valued at approximately USD 4.56 billion. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 6.1% from 2024 to 2031, reaching a market size of USD 7.38 billion by 2031[4].

Regional Analysis

The fluconazole market is segmented into several key regions, including North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region has its own set of drivers and restraints that influence the market dynamics.

• North America: This region is expected to maintain a significant share due to advanced healthcare infrastructure and high awareness of antifungal treatments.
• Asia Pacific: The growing population, especially the elderly, and increasing healthcare expenditures in countries like China and India are driving the demand for fluconazole in this region[3][4].

Market Drivers

Several factors are driving the growth of the fluconazole market:

• Increasing Prevalence of Fungal Infections: The rise in immunocompromised patients, particularly those with HIV/AIDS, cancer, and other chronic conditions, has led to an increased incidence of fungal infections, thereby boosting the demand for fluconazole[4].
• Aging Population: Elderly individuals are more susceptible to fungal infections, contributing to the growing demand for antifungal medications like Diflucan[4].
• Broad-Spectrum Antifungal Action: Fluconazole's efficacy in treating a wide range of fungal infections makes it a preferred choice in both hospital and outpatient settings[4].

Market Restraints

Despite the growth drivers, there are several restraints that could impact the market:

• Generic Competition: The availability of generic versions of fluconazole can reduce the market share of branded products like Diflucan[4].
• Side Effects and Resistance: Concerns over side effects and the potential development of antifungal resistance could limit the market growth[3].

Competitive Landscape

The fluconazole market is highly competitive, with several key players:

• Pfizer: As the original developer of Diflucan, Pfizer has a significant presence in the market. However, the company's revenue from Diflucan has been impacted by the loss of exclusivity and generic competition[2].
• Other Manufacturers: Generic manufacturers and other pharmaceutical companies also play a crucial role in the market, offering affordable alternatives to branded Diflucan[4].

Financial Performance

Historically, Diflucan has been a significant contributor to Pfizer's revenue, although its impact has diminished over the years due to patent expirations and generic competition.

• Pfizer's Financials: In 2019, Pfizer's Biopharma segment, which includes Diflucan, saw an operational revenue growth of 8%, driven by other strong-performing drugs like Ibrance and Eliquis. However, the Upjohn segment, which includes older drugs like Diflucan, experienced a 16% operational decline primarily due to the loss of exclusivity for Lyrica in the U.S.[2].

Market Trends and Opportunities

Several trends and opportunities are shaping the future of the fluconazole market:

• Expanding Indications: Ongoing research aimed at extending the indications of fluconazole could open new market opportunities and sustain growth[4].
• Emerging Markets: The growing healthcare needs in emerging markets, particularly in Asia and Latin America, present significant opportunities for market expansion[3].

PEST and SWOT Analysis

PEST Analysis

• Political Factors: Regulatory changes and healthcare policies can significantly impact the market. For instance, the implementation of volume-based procurement programs in China has affected pharmaceutical sales[2][3].
• Economic Factors: Economic conditions, including healthcare spending and reimbursement policies, influence the demand for fluconazole.
• Social Factors: The increasing awareness of fungal infections and the growing elderly population are key social factors driving the market.
• Technological Factors: Advances in antifungal treatments and the development of new formulations could impact the market dynamics.

SWOT Analysis

• Strengths: Broad-spectrum antifungal action, established brand presence, and widespread use in various medical settings.
• Weaknesses: Generic competition, potential side effects, and antifungal resistance.
• Opportunities: Expanding indications, growing demand in emerging markets, and ongoing research.
• Threats: Regulatory changes, economic downturns, and the rise of alternative treatments.

Consumer Behavior Analysis

Consumer behavior plays a crucial role in the demand for fluconazole. Patients and healthcare providers prefer fluconazole due to its efficacy and ease of administration. However, concerns over side effects and the availability of generic alternatives can influence purchasing decisions.

Technological Trends

Advances in pharmaceutical technology, such as the development of new formulations and delivery systems, can enhance the market prospects for fluconazole. For example, research into oral and intravenous formulations could improve patient compliance and treatment outcomes.

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the fluconazole market. On one hand, the increased focus on healthcare and the rise in immunocompromised patients due to COVID-19 have boosted demand. On the other hand, supply chain disruptions and economic constraints have posed challenges to the market[1].

Key Takeaways

• The global fluconazole market is projected to grow at a CAGR of 6.1% from 2024 to 2031.
• The market is driven by the increasing prevalence of fungal infections, an aging population, and the broad-spectrum antifungal action of fluconazole.
• Generic competition and potential side effects are significant restraints.
• Emerging markets and expanding indications offer future growth opportunities.
• Regulatory changes, economic conditions, and technological advancements are key factors influencing the market dynamics.

FAQs

What is the current market size of the fluconazole market?

The global fluconazole market was valued at approximately USD 4.56 billion in 2023[4].

What is the projected CAGR for the fluconazole market from 2024 to 2031?

The fluconazole market is expected to grow at a CAGR of 6.1% from 2024 to 2031[4].

What are the main drivers of the fluconazole market?

The main drivers include the increasing prevalence of fungal infections, an aging population, and the broad-spectrum antifungal action of fluconazole[4].

How does generic competition affect the fluconazole market?

Generic competition reduces the market share of branded products like Diflucan, making affordable alternatives available to consumers[4].

What are the potential future opportunities for the fluconazole market?

Expanding indications, growing demand in emerging markets, and ongoing research into new formulations and delivery systems are potential future opportunities[3][4].

Sources

1. Global Diflucan Market Report 2024 Edition - Cognitivemarketresearch.com
2. Pfizer Reports Fourth-Quarter and Full-Year 2019 Results - Pfizer.com
3. Fluconazole Drug Market Developments by 2031 - Theinsightpartners.com
4. Fluconazole Market Size, Share and Forecast to 2031 - Marketresearchintellect.com
5. FY2019 Financial Results - Shionogi Inc. - Shionogi.com