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

When do Fluconazole In Sodium Chloride 0.9% In Plastic Container patents expire, and when can generic versions of Fluconazole In Sodium Chloride 0.9% In Plastic Container launch?

Fluconazole In Sodium Chloride 0.9% In Plastic Container is a drug marketed by Baxter Hlthcare, Dr Reddys, Hikma, Hikma Farmaceutica, Hospira, Inforlife, Mylan Labs Ltd, and Woodward. and is included in nine NDAs.

The generic ingredient in FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is fluconazole. There are twenty-three drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the fluconazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fluconazole In Sodium Chloride 0.9% In Plastic Container

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

Summary for FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	8
NDAs:	9
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	274
DailyMed Link:	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Alexion Pharmaceuticals, Inc.	Phase 1
Huashan Hospital	Phase 4
FEMPHARMA Kft.	N/A

See all FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER clinical trials

Pharmacology for FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Drug Class	Azole Antifungal
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A4 Inhibitors

US Patents and Regulatory Information for FLUCONAZOLE 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
Baxter Hlthcare	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	fluconazole	INJECTABLE;INJECTION	076766-001	Jul 29, 2004	AP	RX	No	No
Woodward	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	fluconazole	INJECTABLE;INJECTION	077909-001	May 26, 2010	AP	RX	No	No
Hikma Farmaceutica	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	fluconazole	INJECTABLE;INJECTION	078698-001	Jan 30, 2012	AP	RX	No	No

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

Introduction

Fluconazole in Sodium Chloride 0.9% in Plastic Container, commonly known by the brand name DIFLUCAN, is a synthetic triazole antifungal agent widely used for treating various fungal infections. This article delves into the market dynamics and financial trajectory of this drug, highlighting its current market size, growth prospects, and key factors influencing its demand.

Market Size and Growth Prospects

The global market for Fluconazole Sodium Chloride for Injection is expected to experience significant growth over the next few years. By 2029, the market is projected to reach a substantial value, driven by a compound annual growth rate (CAGR) from 2023 to 2029[1].

Key Applications and End-Use Industries

Fluconazole in Sodium Chloride 0.9% is primarily used to treat infections such as Candidiasis, Cryptococcosis, and Coccidioidomycosis. The expanding demand from these end-use industries is a major driver of the market growth. The drug's efficacy in treating these conditions has made it a staple in antifungal therapy, contributing to its market expansion[1].

Regional Market Analysis

The market is segmented across various regions, including North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. Asia-Pacific, particularly China, shows high growth potential due to increasing healthcare needs and infrastructure development. This region is forecasted to contribute significantly to the overall market growth[1].

Product Formulations and Packaging

Fluconazole in Sodium Chloride 0.9% is formulated as a sterile, iso-osmotic solution containing 2 mg/mL of fluconazole and 9 mg/mL of sodium chloride. It is supplied in flexible plastic containers with volumes of 100 mL and 200 mL, affording doses of 200 mg and 400 mg of fluconazole, respectively. These formulations are designed for intravenous infusion administration and are stored at controlled room temperatures to maintain their efficacy[2][3].

Competitive Landscape

The market for Fluconazole in Sodium Chloride 0.9% is competitive, with several pharmaceutical companies involved in its production and distribution. Pfizer, the original developer of DIFLUCAN, remains a key player, but generic versions from other manufacturers are also available. The presence of multiple suppliers contributes to market competition and pricing dynamics[4].

Financial Trajectory

The financial trajectory of Fluconazole in Sodium Chloride 0.9% is robust, driven by its widespread use and the growing demand for antifungal treatments. The global fluconazole preparation market is projected to grow from $41.75 billion in 2023 to $78.69 billion by 2028, at a CAGR of 13.5%. This growth is attributed to the increasing incidence of fungal infections and the drug's established position in clinical guidelines[4].

Pricing and Cost Factors

The pricing of Fluconazole in Sodium Chloride 0.9% can vary based on the region, supplier, and specific formulation. The cost factors include production costs, regulatory approvals, and market competition. Generic versions of the drug often offer more competitive pricing, which can influence market share and revenue[4].

Clinical Trials and Regulatory Approvals

Fluconazole has undergone extensive clinical trials and has received regulatory approvals in various countries. The drug's safety and efficacy have been well-documented, and it continues to be a subject of ongoing research, particularly in combination therapies. For example, studies have shown that copper acts synergistically with fluconazole to enhance its antifungal effects against certain pathogens[5].

Market Challenges and Opportunities

Despite its strong market position, the Fluconazole in Sodium Chloride 0.9% market faces challenges such as the emergence of resistant fungal strains and the potential for side effects. However, these challenges also present opportunities for innovation, such as the development of new combination therapies and improved formulations. The growing awareness of antifungal resistance is driving research into new treatment strategies, which could further expand the market[5].

Key Takeaways

• Market Growth: The global market for Fluconazole in Sodium Chloride 0.9% is expected to grow significantly by 2029.
• Key Applications: The drug is primarily used for treating Candidiasis, Cryptococcosis, and Coccidioidomycosis.
• Regional Dynamics: Asia-Pacific, particularly China, shows high growth potential.
• Product Formulations: Available in 100 mL and 200 mL flexible plastic containers.
• Financial Trajectory: Projected to grow from $41.75 billion in 2023 to $78.69 billion by 2028.
• Competitive Landscape: Competitive market with both branded and generic versions available.

FAQs

What are the primary uses of Fluconazole in Sodium Chloride 0.9%?

Fluconazole in Sodium Chloride 0.9% is primarily used to treat fungal infections such as Candidiasis, Cryptococcosis, and Coccidioidomycosis.

How is Fluconazole in Sodium Chloride 0.9% formulated and packaged?

It is formulated as a sterile, iso-osmotic solution containing 2 mg/mL of fluconazole and 9 mg/mL of sodium chloride, supplied in 100 mL and 200 mL flexible plastic containers.

What is the projected market growth for Fluconazole in Sodium Chloride 0.9%?

The market is expected to grow significantly by 2029, driven by a CAGR from 2023 to 2029.

Which region shows the highest growth potential for Fluconazole in Sodium Chloride 0.9%?

Asia-Pacific, particularly China, shows high growth potential due to increasing healthcare needs and infrastructure development.

What are the key challenges facing the Fluconazole in Sodium Chloride 0.9% market?

Emergence of resistant fungal strains and potential side effects are key challenges, but they also present opportunities for innovation and new treatment strategies.

Sources

1. QY Research: Fluconazole Sodium Chloride for Injection - Global Market Insights.
2. Pfizer Medical Information: Fluconazole in Sodium Chloride Injection.
3. DailyMed: Fluconazole in Sodium Chloride Injection, USP.
4. Drug Patent Watch: Generic FLUCONAZOLE INN equivalents.
5. Frontiers in Microbiology: Copper Acts Synergistically With Fluconazole in Candida glabrata.