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-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 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
Maastricht University Medical Center	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	4,404,216*PED
Pfizer	DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER	fluconazole	INJECTABLE;INJECTION	019950-005	Jul 8, 1994	4,404,216*PED

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
Ireland	811078
Spain	512882
Norway	811843
Australia	7087781
Australia	541154
New Zealand	199864	TRIAZOLE DERIVATIVES AND FUNGICIDAL AND PLANT GROWTH REGULATING COMPOSITIONS
Denmark	242581

DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Diflucan (Fluconazole) in Dextrose 5% in Plastic Container

Introduction to Diflucan (Fluconazole)

Diflucan, known chemically as fluconazole, is a synthetic triazole antifungal agent used to treat a variety of fungal infections. It is available in several formulations, including tablets, oral suspension, and intravenous solutions, such as the one in dextrose 5% in plastic containers[3].

Market Size and Growth

The global fluconazole market, which includes Diflucan, has been experiencing steady growth. As of 2023, the fluconazole market was valued at USD 4.56 billion and is projected to reach USD 7.38 billion by 2031, growing at a compound annual growth rate (CAGR) of 6.1% from 2024 to 2031[4].

Key Drivers of Market Growth

Several factors are driving the growth of the fluconazole market:

Rising Incidence of Fungal Infections

The increasing incidence of fungal infections, particularly among immunocompromised individuals such as HIV/AIDS patients and those undergoing chemotherapy, is a significant driver. These infections include candidiasis and cryptococcal meningitis, for which fluconazole is a common treatment[2].

Aging Population

The global population is aging, and elderly individuals are more susceptible to fungal infections. This demographic shift is expected to increase the demand for fluconazole[4].

Research and Development

Continuous research and development in the pharmaceutical industry have led to innovations in drug formulations, making fluconazole more convenient and effective. This includes the development of generic versions, which are expected to sustain market growth in the coming years[2].

Regulatory and Healthcare Trends

Healthcare providers are adopting strategies to use antifungals judiciously to prevent resistance and optimize treatment outcomes. Regulatory agencies and guidelines also advocate for responsible antifungal use, further supporting the market growth of fluconazole[2].

Telemedicine and Home Healthcare

The trend towards telemedicine and home healthcare has increased patient access to medications like Diflucan, bolstering its market potential[2].

Market Segmentation and Regional Analysis

The fluconazole market is segmented based on various factors, including drug class, application, and region.

Drug Class

The azoles segment, which includes fluconazole, led the antifungal therapy market in 2022 with a share of approximately 29.1%[5].

Regional Analysis

The market is analyzed at the global, regional, and country levels. Key regions include North America, Europe, Asia-Pacific, and Latin America. The report provides insights into the segment-wise and region-wise breakup of the global fluconazole market[1][2].

Financial Trajectory

Project Economics

For setting up a fluconazole manufacturing plant, the project economics include detailed analyses of capital investments, operating expenses, income and expenditure projections, fixed and variable costs, and expected return on investment (ROI) and net present value (NPV). These analyses are crucial for understanding the financial viability of the project[2].

Revenue Projections

The fluconazole market is expected to grow significantly, with revenue projected to increase from USD 4.56 billion in 2023 to USD 7.38 billion by 2031. This growth is driven by the increasing demand for antifungal treatments and the expanding use of fluconazole in both hospital and outpatient settings[4].

Cost Analysis

The cost analysis includes capital expenditure (CapEx), operating expenditure (OpEx), and other financial metrics. For instance, the report covers the price analysis of feedstocks used in the manufacturing of fluconazole, industry profit margins, and detailed information related to mass balance and raw material requirements[2].

Manufacturing and Production

Manufacturing Process

The manufacturing process of fluconazole involves several unit operations, including the synthesis of the active ingredient, formulation, and packaging. The report provides detailed insights into the manufacturing process flow, raw material requirements, and quality assurance criteria[2].

Plant Setup and Location

The setup of a fluconazole manufacturing plant requires careful consideration of location, infrastructure, machinery, and human resources. The report covers location analysis, plant layout, and factors influencing these decisions[2].

Regulatory and Compliance

Regulatory Procedures

Setting up a fluconazole manufacturing plant involves navigating various regulatory procedures and obtaining necessary approvals. The report provides a comprehensive list of certifications required and details on financial assistance available for such projects[2].

Market Trends and Opportunities

Increasing Demand for Generic Versions

The availability and effective adoption of generic antifungal drugs, including fluconazole, are enhancing treatment procedures and driving market growth. Generic versions are expected to play a significant role in sustaining market growth in the coming years[4].

Innovations in Drug Formulations

Continuous innovations in drug formulations are making fluconazole more convenient and effective. This includes the development of new delivery systems and formulations that improve patient compliance and treatment outcomes[2].

Challenges and Restraints

Antifungal Resistance

One of the significant challenges facing the fluconazole market is the growing concern of antifungal resistance. Healthcare providers are increasingly adopting strategies to use antifungals judiciously to prevent resistance and optimize treatment outcomes[2].

Regulatory Hurdles

Navigating regulatory procedures and obtaining necessary approvals can be complex and time-consuming. This can act as a restraint for new entrants in the market[2].

Key Takeaways

• Market Growth: The fluconazole market is expected to grow from USD 4.56 billion in 2023 to USD 7.38 billion by 2031.
• Key Drivers: Rising incidence of fungal infections, aging population, research and development, and trends in telemedicine and home healthcare.
• Financial Trajectory: The market is driven by increasing demand, with significant revenue projections and detailed cost analyses.
• Manufacturing and Production: Involves complex unit operations, careful location selection, and adherence to regulatory procedures.
• Regulatory and Compliance: Navigating regulatory procedures and obtaining necessary certifications are crucial.

FAQs

Q: What is the projected growth rate of the fluconazole market from 2024 to 2031? A: The fluconazole market is expected to grow at a CAGR of 6.1% from 2024 to 2031[4].

Q: What are the main drivers of the fluconazole market? A: The main drivers include the rising incidence of fungal infections, an aging population, research and development, and trends in telemedicine and home healthcare[2][4].

Q: What are the different formulations of Diflucan (fluconazole)? A: Diflucan is available as tablets, oral suspension, and intravenous solutions, including the one in dextrose 5% in plastic containers[3].

Q: How does the trend towards telemedicine and home healthcare impact the fluconazole market? A: This trend has increased patient access to medications like Diflucan, bolstering its market potential[2].

Q: What are the regulatory challenges in setting up a fluconazole manufacturing plant? A: Setting up a fluconazole manufacturing plant involves navigating various regulatory procedures and obtaining necessary approvals, which can be complex and time-consuming[2].

Sources

1. Global Diflucan Market Report 2024 Edition - Cognitivemarketresearch.com
2. Fluconazole (Diflucan) Manufacturing Plant Project Report 2024 - IMARC Group
3. Diflucan (fluconazale) tablets label - FDA
4. Fluconazole Market Size, Share and Forecast to 2031 - Market Research Intellect
5. Fungal Infections Drive Demand for Anti-fungal Therapies, Market to Reach US$22.8 Billion by 2033 - PR Newswire