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-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% 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	4,404,216*PED
Pfizer	DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	fluconazole	INJECTABLE;INJECTION	019950-004	Jan 29, 1990	4,404,216*PED

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
Ireland	811078
Spain	512882
Norway	811843
Australia	7087781
Australia	541154

DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DIFLUCAN (Fluconazole) in Sodium Chloride 0.9% Solution

Introduction to DIFLUCAN

DIFLUCAN, or fluconazole, is a synthetic triazole antifungal agent widely used for treating various fungal infections. It is available in several formulations, including an intravenous solution in sodium chloride or dextrose diluent. Here, we will delve into the market dynamics and financial trajectory of DIFLUCAN, particularly focusing on its intravenous formulation.

Market Drivers

Increasing Prevalence of Fungal Infections

The demand for antifungal therapies, including DIFLUCAN, is driven by the rising incidence of fungal infections, especially among immunocompromised individuals such as HIV/AIDS patients and those undergoing chemotherapy. This trend is expected to continue as the global population ages and chronic conditions become more prevalent[2][5].

Advancements in Healthcare and Pharmaceutical Research

Continuous research and development in the pharmaceutical industry have led to innovations in drug formulations, making DIFLUCAN more convenient and effective. This includes the development of intravenous solutions that are iso-osmotic, sterile, and nonpyrogenic, enhancing patient treatment outcomes[2][3].

Telemedicine and Home Healthcare

The trend towards telemedicine and home healthcare has increased patient access to medications like DIFLUCAN, further bolstering its market potential. This shift in healthcare delivery models has made antifungal treatments more accessible and convenient for patients[2].

Regional Outlook

Global Market Segmentation

The global antifungal therapy market, which includes DIFLUCAN, is segmented into regions such as North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America and Europe are significant markets due to robust R&D activities and a strong healthcare infrastructure. However, the Asia Pacific region is expected to offer attractive growth opportunities due to local government initiatives and increasing healthcare expenditure[2][5].

Financial Trajectory

Market Size and Growth

The global antifungal therapy market, which DIFLUCAN is a part of, was valued at US$13.8 billion in 2022 and is expected to grow at a CAGR of 4.7% from 2023 to 2033, reaching US$22.8 billion by 2033. The azoles segment, which includes fluconazole, led the market in 2022 with a share of approximately 29.1%[5].

Revenue Projections

The revenue from DIFLUCAN, particularly its intravenous formulation, is expected to increase due to the growing demand for antifungal therapies. The market's growth is driven by the increasing prevalence of fungal infections and the availability of effective generic antifungal drugs, which enhance treatment procedures[5].

Key Financial Metrics

Capital Expenditure and Operating Expenses

For companies involved in the manufacturing of DIFLUCAN, significant capital expenditures are required for setting up manufacturing plants, including costs for machinery, raw materials, and infrastructure. Operating expenses include costs related to production, packaging, transportation, and human resources. Detailed financial analyses, such as those provided in project reports, help in understanding the project economics, including income projections, taxation, depreciation, and liquidity analysis[2].

Return on Investment (ROI) and Net Present Value (NPV)

The ROI and NPV for investments in DIFLUCAN manufacturing are expected to be positive due to the growing demand and stable market growth. Financial analyses, including payback period, profitability analysis, and sensitivity analysis, are crucial for investors and stakeholders to make informed decisions[2].

Regulatory and Compliance Aspects

Regulatory Approvals and Compliance

Manufacturing DIFLUCAN involves adhering to strict regulatory procedures and obtaining necessary approvals. Companies must comply with guidelines set by regulatory agencies to ensure the quality and safety of the drug. This includes passing biological tests for the plastic containers used in the intravenous solution[3].

Competitive Landscape

Market Competition

The antifungal therapy market is competitive, with several key players involved in the development and distribution of antifungal drugs. Companies like Hetero Healthcare Ltd. have launched their own versions of fluconazole, contributing to the market's competitive landscape[5].

Challenges and Opportunities

Resistance and Judicious Use

One of the challenges in the antifungal market is the risk of resistance. Regulatory agencies and healthcare providers are advocating for the judicious use of antifungals to prevent resistance and optimize treatment outcomes. This trend presents an opportunity for companies to develop strategies for responsible antifungal use[2].

Emerging Markets

Emerging markets, particularly in the Asia Pacific region, offer significant growth opportunities for DIFLUCAN due to increasing healthcare expenditure and government initiatives to improve healthcare infrastructure[2][5].

Key Takeaways

• Growing Demand: The demand for DIFLUCAN is driven by the increasing prevalence of fungal infections and advancements in healthcare.
• Financial Growth: The global antifungal therapy market is expected to grow at a CAGR of 4.7% from 2023 to 2033.
• Regional Opportunities: North America and Europe are significant markets, but the Asia Pacific region offers attractive growth opportunities.
• Regulatory Compliance: Adhering to regulatory procedures and obtaining necessary approvals is crucial for manufacturing DIFLUCAN.
• Competitive Landscape: The market is competitive, with several key players involved in the development and distribution of antifungal drugs.

Frequently Asked Questions (FAQs)

Q: What is the expected growth rate of the global antifungal therapy market? A: The global antifungal therapy market is expected to grow at a CAGR of 4.7% from 2023 to 2033[5].

Q: Which region is expected to offer significant growth opportunities for DIFLUCAN? A: The Asia Pacific region is expected to offer attractive growth opportunities due to increasing healthcare expenditure and government initiatives[2][5].

Q: What are the key drivers of the demand for DIFLUCAN? A: The demand for DIFLUCAN is driven by the increasing prevalence of fungal infections and advancements in healthcare, including the trend towards telemedicine and home healthcare[2][5].

Q: What are the regulatory requirements for manufacturing DIFLUCAN? A: Manufacturing DIFLUCAN involves adhering to strict regulatory procedures and obtaining necessary approvals, including passing biological tests for the plastic containers used[3].

Q: How does the competitive landscape of the antifungal therapy market impact DIFLUCAN? A: The competitive landscape of the antifungal therapy market, with several key players involved, drives innovation and competition, which can impact the market share and growth of DIFLUCAN[5].

Cited Sources:

1. Growth Market Reports - Diclofenac Sodium Market Size, Share & Trends Growth [2031][1].
2. IMARC Group - Fluconazole (Diflucan) Manufacturing Plant Project Report 2024[2].
3. FDA - DIFLUCAN® (Fluconazole in Dextrose Injection and Fluconazole in Sodium Chloride Injection, for intravenous use)[3].
4. Verified Market Research - Diclofenac Sodium Market Size, Share, Trends & Forecast[4].
5. PR Newswire - Fungal Infections Drive Demand for Anti-fungal Therapies, Market to Reach US$22.8 Billion by 2033[5].