DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Diflucan In Dextrose 5% In Plastic Container, and what generic alternatives are available?

Diflucan In Dextrose 5% In Plastic Container is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER 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 In Dextrose 5% In Plastic Container

A generic version of DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER was approved as fluconazole by CHARTWELL on July 29^th, 2004.

Summary for DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	40
DailyMed Link:	DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER

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
Zuyderland Medical Centre	Phase 3

See all DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER	fluconazole	INJECTABLE;INJECTION	019950-003	Sep 29, 1992		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 IN DEXTROSE 5% IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER	fluconazole	INJECTABLE;INJECTION	019950-003	Sep 29, 1992
Pfizer	DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER	fluconazole	INJECTABLE;INJECTION	019950-005	Jul 8, 1994

International Patents for DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER

See the table below for patents covering DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	130909
Yugoslavia	42770
Australia	586309

Market Dynamics and Financial Trajectory for Diflucan in Dextrose 5% in Plastic Container

Last updated: March 2, 2026

What is the Current Market Size and Growth for Diflucan (Fluconazole)?

Diflucan, a branded formulation of fluconazole, is an antifungal agent primarily used for treating candidiasis, meningitis, and systemic fungal infections. The global antifungal market was valued at approximately USD 13.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.6% from 2023 to 2030[1].

Within this, fluconazole accounts for a significant share due to its broad spectrum and oral bioavailability. The drug's market share is especially prominent in hospital settings, owing to the increasing prevalence of fungal infections, especially among immunocompromised patients.

How does the formulation affect marketability and sales?

Diflucan in dextrose 5% in a plastic container is a sterile, ready-to-use intravenous formulation. Its advantages include ease of administration and stable shelf life in hospital environments. The formulation's key features:

• Packaging: Plastic container prevents contamination and allows easy handling.
• Solution: Dextrose 5% provides a carbohydrate source, compatible with patients needing nutritional support.
• Administration: Intravenous use targets hospitalized or severely ill patients, emphasizing hospital procurement.

The preference for ready-to-use intravenous solutions influences market penetration, especially in hospital procurement policies and supply chain logistics.

What are the key factors influencing market demand?

Epidemiological trends: Rising incidences of invasive candidiasis, cryptococcosis, and fungal infections among immunosuppressed populations drive demand for fluconazole-based treatments.

Hospitalization rates: Growing hospitalization for cancer, HIV/AIDS, and transplant patients increases IV antifungal sales.

Drug resistance: Increasing resistance to other antifungals pushes demand toward proven agents such as fluconazole.

Generics and pricing: The patent expiry of Diflucan in major markets has led to a surge in generic versions, exerting downward pressure on prices but expanding access.

How do patent statuses and regulatory policies influence the market?

Pfizer's patent for Diflucan expired in key jurisdictions, including the U.S. in 2011 and the European Union in 2012. This opened markets for generic fluconazole manufacturers, increasing competition.

Regulatory agencies (FDA, EMA) have fast-tracked approvals for generics, and biosimilar policies have further increased market entrants. This has decreased prices and increased volume sales.

How does regional variation impact the financial trajectory?

North America: Largest market, driven by high healthcare expenditure, advanced hospital infrastructure, and widespread antifungal use. Growth is steady, with volume driven by generics.

Europe: Similar to North America, with mature markets experiencing price competition, but with steady demand.

Asia-Pacific: Fastest growth due to increasing healthcare infrastructure, rising fungal infection incidences, and expanding hospital networks. Market growth rates in this region surpass global averages, with CAGR estimated above 6%[2].

Latin America & Middle East: Steady expansion driven by healthcare investments and increasing disease burden.

What are the revenue projections for Diflucan in Dextrose 5% in Plastic Container?

Given the generic competition and regional differences, revenues are expected to decline in premium markets over the next five years. However, the volume sales in emerging markets will likely offset some losses.

Estimated Global Revenue (2023–2028):

Year	USD Billion	Notes
2023	1.8	Baseline for branded and generic forms
2024	1.75	Slight decline due to entry of generics
2025	1.7	Continued price competition
2026	1.65	Market saturation in developed regions
2027	1.6	Growth stabilizes in mature markets
2028	1.55	Expansion in Asia-Pacific and Latin America

Note: Prices of generic fluconazole in low-cost markets are approximately 20-30% lower than branded versions.

Critical factors influencing long-term financial performance:

• Patent expirations: Further market entry for biosimilars or newer antifungals could impact sales.
• Manufacturing costs: Lower costs for generic production, especially in low-cost regions.
• Regulatory changes: Approval processes for generics could influence market entry timing.
• Healthcare policies: Price control measures and reimbursement policies impact profitability.

Key Takeaways

• The global antifungal market, especially for fluconazole, is characterized by steady growth driven by increasing fungal infections.
• Patent expirations have led to a surge in generic formulations, intensifying price competition.
• Regional disparities are significant: North America remains mature; Asia-Pacific offers higher growth prospects.
• Revenues for Diflucan in Dextrose 5% in plastic containers are expected to decline modestly in developed markets but grow robustly in emerging economies.
• Price sensitivity and regulatory environment are critical to future market share and profitability.

FAQs

1. What is the main driver for the demand of Diflucan in IV formulation?
The main driver is the rise of invasive fungal infections among hospitalized and immunocompromised patients requiring intravenous therapy.

2. How does patent expiry impact the price of fluconazole?
Patent expiry allows generic manufacturers to enter the market, significantly reducing prices and increasing volume sales.

3. Which regions are expected to see the fastest growth for this formulation?
The Asia-Pacific region is expected to grow faster, driven by expanding healthcare infrastructure and rising disease prevalence.

4. What are the main challenges facing the market for Diflucan in Dextrose 5%?
Market challenges include intense price competition from generics, regulatory delays, and potential shifts toward newer antifungal agents.

5. How does formulation packaging affect drug sales?
Plastic containers for IV solutions offer logistical advantages, supporting higher hospital utilization and continuing demand in hospital settings.

References

[1] MarketsandMarkets. (2022). Antifungal Drugs Market by Type, Application, and Region: Global Forecast 2022–2030.

[2] Grand View Research. (2022). Fluconazole Market Size, Share & Trends Analysis Report.