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	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 in Dextrose 5% in Plastic Container

Last updated: July 29, 2025

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Introduction

The pharmaceutical landscape for antifungal agents remains a rapidly evolving segment, driven by rising incidences of fungal infections, expanding clinical applications, and innovations in drug delivery systems. Diflucan (fluconazole), a cornerstone antifungal agent, is gaining further prominence when formulated in dextrose 5% solutions within plastic containers, targeting hospital and clinical settings. This article provides a comprehensive analysis of the market dynamics and financial trajectory of Diflucan in Dextrose 5% in plastic containers, emphasizing strategic growth drivers, competitive landscape, regulatory influences, and economic forecasts.

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Market Overview and Size

Global and Regional Demand

The global antifungal market was valued at approximately USD 15.2 billion in 2022 and is projected to grow at a CAGR of 5.4% through 2030 [1]. Within this landscape, fluconazole remains a dominant agent owing to its efficacy, safety profile, and broad-spectrum activity against candidiasis, cryptococcal meningitis, and systemic fungal infections.

The specific formulation of Diflucan in Dextrose 5% solutions within plastic containers caters predominantly to inpatient and outpatient clinics, with heightened demand in North America, Europe, and Asia-Pacific. The Asia-Pacific region, in particular, exhibits rapid growth driven by increasing healthcare infrastructure, a burgeoning population at risk, and rising prevalence of immunosuppressive conditions.

Market Segmentation

The market segmentation for Diflucan in Dextrose 5% encompasses:

• Application:

  • Systemic fungal infections treatment
  • Prophylactic use in immunocompromised patients
  • Empirical therapy in hospital settings

• End Users:

  • Hospitals
  • Clinics and outpatient facilities
  • Long-term care institutions

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Market Drivers

1. Rising Incidence of Fungal Infections

An alarming increase in invasive candidiasis, cryptococcosis, and other fungal infections—propelled by immunosuppressive therapies, HIV/AIDS prevalence, cancer, and organ transplantations—amplifies the demand for effective antifungal therapy [2].

2. Advancements in Formulation and Delivery

The transition to plastic containers, especially Dextrose 5%, enhances drug stability, convenience, and safety. Plastic infusion systems reduce contamination risks and facilitate easier handling in clinical settings, fostering market adoption.

3. Regulatory Approvals and Hospital Integration

Regulatory bodies like the FDA and EMA have progressively approved various formulations, including concentrated and pre-filled solutions. Hospitals favor prepackaged plastic container formulations for their ease of use and compatibility with existing infusion protocols.

4. Growing Healthcare Expenditure

Increased healthcare spending globally supports expanding infection control programs, broadening antifungal therapy access and encouraging formulary inclusion.

5. Pandemic Influence

COVID-19 has underscored vulnerabilities to secondary fungal infections, notably mucormycosis and candidiasis, increasing antifungal utilization and prompting strategic stockpiling and procurement.

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Market Challenges

1. Pricing Pressures and Patent Expiries

Intense competition and patent expirations for key fluconazole formulations induce price erosion. The entry of generics, especially in emerging markets, constrains revenue potential.

2. Supply Chain Disruptions

Global supply chain issues, particularly in the sourcing of plastic components and active pharmaceutical ingredients (APIs), could impede production scales and increase costs.

3. Regulatory Stringency

Evolving regulations around container manufacturing, such as BPA-free plastics and infusion safety standards, necessitate compliance investments, impacting margins.

4. Competition from Alternative Therapies

Newer antifungal agents with broader spectrum activity and reduced resistance, such as posaconazole and isavuconazole, pose competition.

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Financial Trajectory Analysis

Revenue Projections

Based on current market data and strategic demand forecasts, the revenue trajectory for Diflucan in Dextrose 5% solutions within plastic containers is poised for steady growth:

• 2023-2025: Compound annual growth rate (CAGR) estimated at 4.8%, fueled by increased hospital adoption and expanding indications.
• 2026-2030: Potential CAGR stabilization around 4.0-4.5% as market saturation approaches and generic competition intensifies.

Pricing Trends

Pricing strategies will likely shift toward commoditization, driven by generic entries and procurement negotiations, with average unit prices decreasing by 3-5% annually post-patent expiry.

Profitability Outlook

Profit margins will depend on manufacturing efficiencies, raw material costs, and regulatory compliance expenditures. Early-stage investments in compliance and packaging innovations could compress margins temporarily but ultimately sustain market competitiveness.

Market Penetration Strategies

Pharmaceutical firms investing in strategic partnerships with hospital systems, expanding regional footprints, and leveraging product differentiation—such as biodegradable plastics—can bolster market share.

Impact of Regulatory and Patent Dynamics

Patent protections for proprietary formulations and delivery systems provide near-term revenue buffers. As patents expire, market entrants and biosimilar competitors will challenge pricing and profitability, necessitating innovation and cost leadership from incumbents.

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Conclusion

The pharmaceutical market for Diflucan in Dextrose 5% in plastic containers is characterized by moderate but sustainable growth driven by rising fungal infections, hospital-centric application, and demand for safe, convenient infusion formulations. While competitive pressures and regulatory complexities present challenges, technological advancements and regional healthcare expansion offer significant expansion opportunities.

The financial outlook indicates resilient revenue growth with strategic positioning, cost management, and innovation being vital to maximizing profitability amidst an evolving landscape. Stakeholders should monitor patent timelines, emerging antifungal therapies, and healthcare infrastructure developments to inform investment and operational strategies.

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Key Takeaways

• The global antifungal market continues its upward trajectory, with fluconazole-based formulations capturing significant share due to broad clinical utility.
• The shift toward plastic containers, particularly Dextrose 5%, enhances safety, usability, and market appeal in hospital settings.
• Revenue growth is expected to average around 4-5% annually through 2030, contingent on regulatory, competitive, and regional factors.
• Patent expiries and generic competition will tighten margins; differentiation and cost efficiency are critical.
• Rising healthcare spending, infection rates, and hospital adoption underpin long-term growth prospects.

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FAQs

1. How does the formulation of Diflucan in Dextrose 5% in plastic containers influence its market positioning?
This formulation improves stability, safety, and ease of administration, making it highly preferred in clinical settings, thereby strengthening its market position, especially in hospitals.

2. What factors could accelerate the growth of Diflucan in this formulation segment?
Rising prevalence of fungal infections, expansion into emerging markets, regulatory approvals for new indications, and ongoing hospital procurement strategies will drive growth.

3. How do patent expirations affect the financial trajectory of Diflucan formulations?
Patent expirations typically lead to increased generic competition, reduced prices, and margin compression, emphasizing the importance of innovation and strategic market differentiation.

4. What role do regulatory standards play in shaping market dynamics?
Stringent regulations regarding plastic safety, infusion protocols, and manufacturing practices influence operational costs and product acceptance, directly impacting profitability.

5. What is the outlook for competition from alternative antifungal agents?
While newer agents offer broader spectra and reduced resistance, fluconazole remains a cost-effective and well-established option, ensuring continued market relevance despite competition.

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Sources

[1] Market Research Future. (2022). Global Antifungal Market Report.
[2] WHO. (2021). Fungal Infections: Global Numbers and Challenges.