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
CSPC Ouyi Pharmaceutical Group Co., Ltd.	N/A
Peking Union Medical College Hospital	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	130909
Yugoslavia	42770
Australia	586309
Hong Kong	86087	FUNGICIDAL BIS-AZOLYL COMPOUNDS
Bosnia and Herzegovina	97145
Japan	S6337102

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

Last updated: February 8, 2026

Market Overview

Diflucan (fluconazole) in sodium chloride 0.9% in a plastic container is a hospital and infusion center drug. It combines the antifungal properties of fluconazole with a compatible IV formulation. Primarily, this formulation addresses the need for intravenous antifungal therapy, especially in immunocompromised patients or in hospital settings where oral administration is unfeasible.

Key market drivers include:

• Growth in invasive fungal infections, especially among oncology and transplant populations.
• Expansion of intravenous drug use in hospital protocols.
• Increasing antimicrobial resistance requiring potent antifungal options.
• Trends toward ready-to-use IV formulations reducing preparation time.

Market Size and Revenue Projections

In 2022, the global antifungal market was valued at approximately USD 6.2 billion. The segment for IV formulations, including fluconazole in various forms, accounts for roughly 35% of this market, or USD 2.17 billion.

Diflucan’s specific market share in this segment remains competitive but is challenged by generics and rising biosimilar options. The global value for fluconazole's IV form is projected to grow at a compound annual growth rate (CAGR) of 3.5% over the next five years, reaching approximately USD 2.7 billion by 2027.

Within this, the sodium chloride 0.9% formulation has a niche but stable position. Retail or hospital procurement data show steady demand for pre-filled, ready-to-serve IV antifungal solutions, especially in North America and Europe, which account for over 70% of the market.

Competition Landscape

The main competitors include:

• Generics of fluconazole IV (e.g., Teva, Mylan) that offer lower prices.
• Other antifungal IV drugs such as voriconazole and amphotericin B, which target more resistant fungi.
• Biosimilar fluconazole formulations entering markets in 2023 and beyond.

Brand loyalty and hospital formulary preferences slow the shift toward generics but are gradually changing as cost pressures mount. Pricing for Diflucan in a plastic container typically ranges from USD 4 to USD 8 per vial, depending on dosage and region.

Regulatory and Reimbursement Factors

Regulatory approvals in major markets affirm the safety and efficacy of fluconazole IV formulations in complex hospital environments. Reimbursement policies favor prepaid hospital care, with Medicaid and Medicare covering most US intravenous antifungal treatments.

Pricing pressures and hospital procurement contracts influence revenue margins. In the US, drug reimbursement often falls under Diagnosis-Related Group (DRG) payments, which cap hospital costs, reducing direct drug revenue's impact on overall profitability.

Supply Chain and Market Risks

Supply chain disruptions, especially following the COVID-19 pandemic, have affected raw material availability and manufacturing timelines. Scarcity of specific plastic components or active pharmaceutical ingredients (API) could constrict supply, affecting sales volume.

Generics' market entry and biosimilars' expanding presence pose ongoing price erosion. The increasing shift toward oral formulations for outpatient care reduces IV demand.

Financial Outlook

Revenue growth for Diflucan in sodium chloride 0.9% in plastic containers is expected to be modest, reflecting market maturity. Factors constraining growth:

• Price competition from generics.
• Transition to oral formulations.
• Market saturation in developed regions.

Investment in formulation improvements or expansion into emerging markets could mitigate decline. Companies with patent protections and exclusive supply agreements maintain higher margins but face expiry risks of key patents in 2025-2027.

Strategic Considerations

• Focus on formulary position to prolong exclusive distribution.
• Diversify into biosimilar markets.
• Increase presence in emerging economies with expanding hospital infrastructure.
• Innovate with ready-to-use, combination IV solutions.

Key Takeaways

• The global antifungal IV market, including Diflucan in sodium chloride 0.9%, grows slowly at around 3.5% CAGR by 2027.
• Competition from generics and biosimilars cuts into revenue and margins.
• Hospital procurement and reimbursement policies strongly influence sales.
• Supply chain stability and innovation are critical for maintaining market share.
• Long-term growth depends on diversification and expanding into underserved regions.

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FAQs

1. How does patent expiry affect Diflucan’s market?
Patent expiration permits generic manufacturers to produce lower-cost alternatives, increasing competition and reducing Diflucan’s market share and pricing power.

2. What role do biosimilars play in the IV antifungal market?
Biosimilars introduce alternatives with similar efficacy but potentially lower costs, intensifying price competition and squeezing margins for brand-name drugs like Diflucan.

3. Are there emerging substitutes for IV fluconazole formulations?
Yes. Oral formulations and newer antifungals like isavuconazole and posaconazole can replace IV options in outpatient or less critical settings, impacting IV market demand.

4. How significant is the North American market for Diflucan in saline?
North America accounts for over 40% of global sales of IV antifungals, with hospital usage driven by high incidences of invasive fungal infections and established formulary preferences.

5. What innovations could influence future revenues?
Development of combination IV solutions, improved stability, and formulations designed for specific populations could extend product lifecycle and market relevance.

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References

[1] Market research, "Global Antifungal Market," 2022. [2] IQVIA, "Hospital Pharmacy Trends," 2022. [3] "US FDA Drug Approvals," 2022. [4] Transparency Market Research, "Biosimilars," 2023. [5] Deloitte, "Pharmaceutical Supply Chain," 2023.