DIFLUCAN IN SODIUM CHLORIDE 0.9% Drug Patent Profile

Which patents cover Diflucan In Sodium Chloride 0.9%, and when can generic versions of Diflucan In Sodium Chloride 0.9% launch?

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

The generic ingredient in DIFLUCAN IN SODIUM CHLORIDE 0.9% is fluconazole. There are twenty-three drug master file entries for this compound. Forty-five 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%

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

Summary for DIFLUCAN IN SODIUM CHLORIDE 0.9%

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

Recent Clinical Trials for DIFLUCAN IN SODIUM CHLORIDE 0.9%

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 IN SODIUM CHLORIDE 0.9% clinical trials

US Patents and Regulatory Information for DIFLUCAN IN SODIUM CHLORIDE 0.9%

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%	fluconazole	INJECTABLE;INJECTION	019950-001	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
Pfizer	DIFLUCAN IN SODIUM CHLORIDE 0.9%	fluconazole	INJECTABLE;INJECTION	019950-006	Jan 29, 1990		DISCN	Yes	No

Expired US Patents for DIFLUCAN IN SODIUM CHLORIDE 0.9%

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	DIFLUCAN IN SODIUM CHLORIDE 0.9%	fluconazole	INJECTABLE;INJECTION	019950-001	Jan 29, 1990
Pfizer	DIFLUCAN IN SODIUM CHLORIDE 0.9%	fluconazole	INJECTABLE;INJECTION	019950-001	Jan 29, 1990

International Patents for DIFLUCAN IN SODIUM CHLORIDE 0.9%

See the table below for patents covering DIFLUCAN IN SODIUM CHLORIDE 0.9% around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	1182822	INTERMEDIAIRES DU TRIAZOLE ET DE L'IMIDAZOLE (TRIAZOLE AND IMIDAZOLE INTERMEDIATES)
Ireland	53144	TRIAZOLE ANTIFUNGAL AGENTS,PROCESSES FOR PREPARING THEM,AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Finland	74280

Market Dynamics and Financial Trajectory for DIFLUCAN IN SODIUM CHLORIDE 0.9%

Last updated: August 4, 2025

Introduction

DIFLUCAN IN SODIUM CHLORIDE 0.9%, a formulation combining the antifungal agent fluconazole with an isotonic saline solution, targets a niche yet pivotal segment within infectious disease management. Its market trajectory is influenced by factors such as rising antifungal resistance, growing prevalence of fungal infections, and advancements in infusion therapies. This analysis explores the key market drivers, competitive landscape, regulatory environment, and projected financials, providing a comprehensive outlook for stakeholders.

Market Overview

Product Profile and Therapeutic Significance

DIFLUCAN (fluconazole) is a triazole antifungal agent predominantly indicated for systemic fungal infections, including candidiasis and cryptococcal meningitis. When administered intravenously in sodium chloride 0.9%, it offers advantages in hospital settings, especially for patients requiring parenteral therapy.

The medical necessity for infusion solutions infused with antifungal agents surges amid escalating fungal infection rates among immunocompromised populations—notably AIDS/HIV patients, chemotherapy recipients, and organ transplant recipients. As such, this formulation plays a vital role in inpatient care, intensifying its market demand.

Market Size and Segments

Globally, the antifungal drugs market was valued at approximately USD 13.1 billion in 2021 and is projected to grow at a CAGR of around 4.8% through 2028 [1]. The intravenous segment, specifically, is dominant in acute care markets, representing a significant proportion of this growth.

The sale of DIFLUCAN IN SODIUM CHLORIDE 0.9% is primarily concentrated in hospital pharmacies and infusion clinics, with North America leading due to high healthcare expenditure, extensive healthcare infrastructure, and prevalence of fungal infections.

Market Dynamics

Driving Factors

1. Increasing Incidence of Fungal Infections
A global rise in invasive fungal infections correlates with growing immunosuppressed populations. The CDC reports that candidemia affects approximately 25,000 hospitalized patients annually in the U.S., with high mortality rates [2]. The need for effective intravenous antifungal formulations like DIFLUCAN in saline solutions drives positive market dynamics.

2. Expanding Use in Hematology and Oncology
Chemotherapy and hematopoietic stem cell transplantation recipients are at higher risk for fungal infections. The expanding scope of antifungal prophylaxis and treatment fuels the adoption of formulations like DIFLUCAN IN SODIUM CHLORIDE 0.9%.

3. Advancements in Intravenous Therapy Infrastructure
Medical innovations, including smart infusion pumps and improved infusion protocols, augment the suitable delivery of antifungal agents, bolstering demand.

4. Patent Expirations and Generic Adoption
While fluconazole’s patent expired in 2000, the formulation’s compatibility with saline solutions remains critical for specific clinical needs. The introduction of generic formulations has increased market accessibility, reducing costs for healthcare providers.

Challenges and Restraints

1. Competition from Alternative Antifungals
Echinocandins (e.g., caspofungin) and newer triazoles (e.g., voriconazole) offer alternative treatment options, potentially limiting market share.

2. Regulatory and Safety Considerations
Concerns over adverse effects such as hepatotoxicity necessitate careful patient selection and monitoring, which may impact uptake.

3. Price Sensitivity and Healthcare Budgets
Cost containment pressures in healthcare systems influence procurement decisions, favoring more cost-effective alternatives or generics.

Competitive Landscape

Major pharmaceutical companies like Pfizer (original developer), Mylan, and Sandoz produce generic versions of fluconazole in saline solutions. Differentiation hinges on formulation purity, ease of infusion, and regulatory compliance.

Other players focus on developing novel antifungal agents with broader spectrums and improved safety profiles, indirectly affecting demand for traditional formulations.

Regulatory Environment

Regulatory agencies such as the FDA and EMA oversee approval and post-market surveillance, ensuring safety and efficacy. The combination of antifungal agents with saline solutions requires meticulous stability and compatibility testing, with approvals varying across jurisdictions.

In recent years, expedited review pathways and orphan drug designations have expedited access for certain formulations targeting critical patient populations.

Financial Trajectory Forecast

Historical Performance

DIFLUCAN in its branded form enjoyed robust sales since its debut, with peak revenues attained in the early 2000s. The subsequent generic entry stabilized and reduced pricing, although demand remained stable owing to clinical necessity.

Projected Trends

1. Growth Drivers

• Rising incidence of immunocompromised states.
• Increased adoption of intravenous antifungal therapy in emerging markets.
• Technological advances in infusion devices ensuring safer delivery.

2. Market Penetration and Expansion
Emerging economies like India, China, and Brazil exhibit expanding healthcare sectors, presenting opportunities for increased sales volume.

3. Revenue Forecasts
According to industry projections, global sales of fluconazole formulations in saline are expected to grow at a CAGR of approximately 3.5%-4.0% over the next five years, driven by increasing demand in critical care settings. The segment’s revenue could approach USD 650–700 million by 2028, factoring in generic competition and growing infection rates (assumed based on market trends).

Profitability Analysis

Margins are influenced by manufacturing costs, competitive pricing, regulatory compliance, and market share. While branded formulations command premium pricing, generic versions primarily compete on cost efficiency. The profitability of DIFLUCAN in saline formulations is expected to stabilize within a range of 25–35%, contingent on regional factors.

Strategic Considerations for Stakeholders

• Innovate on formulations to improve infusion stability and reduce adverse effects.
• Expand clinical trials to demonstrate efficacy in broader patient populations, strengthening regulatory submissions and market acceptance.
• Engage in strategic collaborations with healthcare providers and distributors, especially in emerging markets.
• Monitor regulatory policies to adapt swiftly to changing compliance standards and approval pathways.

Key Takeaways

• The market for DIFLUCAN IN SODIUM CHLORIDE 0.9% is shaped by the increasing prevalence of fungal infections, particularly among immunocompromised patients.
• Growth opportunities stem from expanding use in critical care, rising healthcare infrastructure in emerging markets, and technological upgrades in infusion delivery.
• Competitive dynamics are influenced by generic entrants, alternative antifungals, and regulatory considerations, necessitating continual innovation and strategic positioning.
• Financial forecasts indicate moderate but steady growth accelerated by global healthcare spending and infection control measures.
• Stakeholders should focus on clinical evidence generation, cost-effective manufacturing, and geographic expansion to capitalize on market opportunities.

FAQs

1. What are the primary clinical advantages of DIFLUCAN IN SODIUM CHLORIDE 0.9% over other antifungal formulations?
It offers compatibility with saline infusion protocols, ensuring ease of administration in hospital settings and reducing the risk of infusion-related incompatibilities. Its proven efficacy against a broad spectrum of fungi enhances its clinical utility.

2. How does the emergence of generic fluconazole impact the market for DIFLUCAN formulations?
Generics increase market accessibility by lowering costs, pressuring branded formulations to justify premium pricing. Innovators may focus on formulation improvements or specialized applications to differentiate.

3. What are the key factors influencing the adoption of DIFLUCAN in saline in emerging markets?
Healthcare infrastructure, regulatory approval processes, local disease prevalence, and economic capacity significantly influence adoption rates.

4. Are there specific regulatory hurdles for combining antifungals with saline solutions?
Yes. Stability, compatibility, and safety testing are mandatory, and regulatory approval may vary based on regional standards and existing clinical data.

5. What future innovations could enhance the market prospects for DIFLUCAN in saline?
Development of sustained-release formulations, improved infusion devices, and evidence of efficacy in new indications could bolster demand.

References

[1] MarketsandMarkets. Antifungal Drugs Market by Type, Route of Administration, Distribution Channel, and Region – Global Forecast to 2028.
[2] Centers for Disease Control and Prevention (CDC). Invasive Fungal Infections: Data & Statistics.