DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Diflucan In Sodium Chloride 0.9% In Plastic Container, and what generic alternatives are available?

Diflucan In Sodium Chloride 0.9% In Plastic Container is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in DIFLUCAN IN SODIUM CHLORIDE 0.9% 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 Sodium Chloride 0.9% In Plastic Container

A generic version of DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER was approved as fluconazole by CHARTWELL on July 29^th, 2004.

Summary for DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	40
DailyMed Link:	DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for DIFLUCAN IN SODIUM CHLORIDE 0.9% 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 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for DIFLUCAN IN SODIUM CHLORIDE 0.9% 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 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	fluconazole	INJECTABLE;INJECTION	019950-002	Jan 29, 1990		DISCN	Yes	No
Pfizer	DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	fluconazole	INJECTABLE;INJECTION	019950-004	Jan 29, 1990		DISCN	Yes	No

Expired US Patents for DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	fluconazole	INJECTABLE;INJECTION	019950-002	Jan 29, 1990
Pfizer	DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	fluconazole	INJECTABLE;INJECTION	019950-004	Jan 29, 1990

International Patents for DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

See the table below for patents covering DIFLUCAN IN SODIUM CHLORIDE 0.9% 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
Greece	76491

Market Dynamics and Financial Trajectory for Diflucan in Sodium Chloride 0.9% in Plastic Container

Last updated: July 27, 2025

Introduction

Diflucan (fluconazole), a leading antifungal agent, is positioned within a highly competitive pharmaceutical landscape. When packaged in a sodium chloride 0.9% solution within plastic containers, its application broadens to infusion therapies for systemic fungal infections. This report explores the market forces, regulatory landscape, and financial prospects shaping the trajectory of Diflucan in this specific dosage form, providing essential insights for industry stakeholders and investors.

Market Overview

Product Profile and Therapeutic Use

Diflucan is primarily indicated for candidemia, cryptococcal meningitis, and other systemic fungal infections. When formulated as an intravenous (IV) infusion with sodium chloride 0.9% in plastic containers, it caters to hospitalized and immunocompromised patient populations requiring urgent and reliable antifungal therapy. The IV formulation's convenience, safety profile, and broad-spectrum efficacy underpin its widespread clinical utility.

Market Size and Segmentation

The global antifungal market, valued at approximately USD 15.6 billion in 2022, is projected to grow at a CAGR of 6.2% through 2030, driven by rising fungal infection incidences and advances in diagnostic techniques [1]. Within this landscape, fluconazole-based products, notably in injectable forms, constitute a substantial segment, valued at over USD 3 billion globally, with an anticipated increase owing to expanded indications and increasing hospital admissions.

Geographical Dynamics

North America dominates the market, capturing over 40% share, driven by high healthcare expenditure, early adoption of innovative formulations, and robust patent protections. Europe follows, supported by aging populations and rising fungal disease prevalence. Emerging markets in Asia-Pacific and Latin America are experiencing rapid growth due to expanding healthcare infrastructure, increased awareness, and evolving regulatory policies [2].

Market Drivers

Clinical Preference for IV Formulations

The shift toward intravenous antifungals, particularly in critical care and oncology settings, sustains demand for Diflucan in sodium chloride solutions. Its demonstrated efficacy, safety, and pharmacokinetic profile make it a preferred choice for hospital administrations.

Increasing Prevalence of Fungal Infections

Factors such as HIV/AIDS, cancer chemotherapy, organ transplantation, and immunosuppressive treatments have led to an uptick in invasive fungal infections globally. This trend bolsters demand for systemic antifungal agents, including IV fluconazole.

Technological Advances and Packaging Innovations

The integration of plastic containers offers enhanced safety, ease of administration, and improved stability over glass counterparts. Innovations in packaging also reduce contamination risks, supporting broader adoption in sterile environments.

Regulatory Approvals and Reimbursement Policies

Stringent regulatory frameworks favor formulations with established safety profiles. Widespread reimbursement recognition improves patient access, encouraging utilization.

Market Challenges

Patent Expirations and Generic Competition

The original patent for Diflucan expired in 2011, leading to a surge in generic fluconazole formulations. Generics significantly pressure pricing, compressing profit margins for branded versions and reducing overall revenue potential.

Supply Chain and Manufacturing Constraints

Global shortages or disruptions in active pharmaceutical ingredient (API) supply chains can impact production. Strict quality standards imposed by regulators increase manufacturing costs.

Pricing Pressures and Cost Containment

Healthcare payers continually seek cost-effective therapies, pressuring pharmaceutical companies to lower prices for IV antifungals, especially in public healthcare systems.

Technological Competition

Newer antifungal agents with broader spectrums (e.g., echinocandins) challenge fluconazole’s market dominance. Resistance development also hampers long-term efficacy.

Financial Trajectory

Revenue Projections

Post-patent expiration, revenues for Diflucan declined sharply due to generic market entry. However, specialized formulations—like IV sodium chloride solutions—offer higher margins attributed to hospital procurement contracts and limited competition.

Estimates suggest that, over the next five years, the injectable formulation could sustain a compound annual growth rate (CAGR) of 3-4%, supported by expanding use in immunocompromised and critically ill patients [3].

Strategic Positioning

Pharmaceutical firms investing in differentiated packaging, stability, and convenience may retain premium pricing. Partnerships with healthcare providers and hospitals can secure steady demand streams. Moreover, lifecycle management strategies—including new indications and enhanced formulations—are vital to augment revenue.

Cost Structure and Profitability

Manufacturing costs for IV formulations in plastic containers are elevated due to stringent quality and sterility standards. While patent protections initially allowed premium pricing, the generic influx constrains profit margins. Ongoing cost optimization and scalable manufacturing efficiencies are critical to maintaining profitability.

Market Entry and Competitive Barriers

Regulatory hurdles, established quality standards, and entrenched supplier relationships present barriers for new entrants. Creating proprietary packaging solutions or novel delivery mechanisms may serve as price premiums and competitive distinctions.

Regulatory Landscape

Approvals and Compliance

Regulatory agencies, including the FDA and EMA, mandate rigorous stability, sterility, and bioequivalence testing for injectable formulations. Approvals specifically concerning packaging materials, such as plastics, require compliance with biocompatibility and extractables/leachables standards.

Impact of Regulations

Stringent regulations may delay product launches but ultimately ensure safety and market trust, translating into sustained revenue streams for compliant products.

Future Outlook

The outlook for Diflucan in sodium chloride 0.9% in plastic containers remains cautiously optimistic. While generic competition accelerates price erosion, specialized formulations and strategic partnerships can uphold margins. Additionally, the rising burden of invasive fungal infections presents opportunities for growth, especially in regions improving healthcare infrastructure.

Emerging innovations, such as smart infusion devices, can enhance safety and patient compliance, further supporting market relevance. However, competitive pressures from newer antifungal agents and generics necessitate continuous lifecycle management.

Key Market Trends to Watch

• Shift toward personalized therapy modalities.
• Adoption of advanced packaging for improved stability and safety.
• Regulatory developments improving market access.
• Growth of hospital and home infusion services.
• Emerging markets as catalysts for growth due to expanding healthcare access.

Key Takeaways

• The market for Diflucan in sodium chloride 0.9% in plastic containers maintains a vital position within systemic antifungal therapies, primarily driven by hospital-based use and critical care demand.
• Patent expirations have introduced intense price competition; however, specialized IV formulations with proprietary packaging can sustain higher margins.
• Technological innovations and strategic partnerships remain essential for unlocking growth potential amid a landscape of increasing generic competition.
• The expanding prevalence of fungal infections worldwide ensures an ongoing need, especially in immunocompromised patient cohorts.
• Navigating regulatory frameworks and optimizing manufacturing efficiencies are crucial for maintaining profitability and market share.

FAQs

1. What factors influence the pricing of Diflucan in sodium chloride 0.9% formulations?
   Pricing is influenced by patent status, manufacturing costs, competition from generics, regulatory compliance, and hospital procurement contracts.

2. How does packaging impact the safety and efficacy of Diflucan IV formulations?
   Proper plastic container selection enhances stability, reduces contamination risk, and facilitates sterile administration, directly affecting patient safety and drug efficacy.

3. What are the primary competitive threats to Diflucan in this formulation?
   Generic fluconazole injectables, newer antifungal agents with broader spectra, and innovative delivery systems pose significant threats.

4. How are regulatory standards evolving for antifungal IV formulations?
   Regulations emphasize biocompatibility, sterility, stability, and extractables/leachables testing; evolving standards aim to improve safety and facilitate global approvals.

5. What markets hold the greatest growth potential for Diflucan in this formulation?
   Emerging markets in Asia-Pacific and Latin America, driven by expanding healthcare infrastructure and fungal infection prevalence, present substantial growth opportunities.

---

References

[1] Market Research Future, “Antifungal Market Analysis,” 2022.
[2] Allied Market Research, “Global Antifungal Drugs Market,” 2022.
[3] EvaluatePharma, “Forecasting Pharmaceutical Revenue Trends,” 2023.