Fluconazole - Generic Drug Details

What are the generic drug sources for fluconazole and what is the scope of freedom to operate?

Fluconazole is the generic ingredient in eight branded drugs marketed by Pfizer, Aurobindo Pharma, Hainan Poly, Hikma, Ivax Sub Teva Pharms, Sun Pharm Inds Ltd, Taro Pharm Inds, Hikma Farmaceutica, Hospira, Norvium Bioscience, Woodward, Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, Baxter Hlthcare, Inforlife, Mylan Labs Ltd, West-ward Pharms Int, Ani Pharms, Chartwell, Dr Reddys Labs Inc, Gedeon Richter Usa, Glenmark Pharms Ltd, Lupin Ltd, Mylan Pharms Inc, Pliva, Ranbaxy Labs Ltd, Roxane, Taro, Teva, Thinq Pharm-cro Pvt, and Zydus Pharms, and is included in forty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for fluconazole. Forty-five suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for fluconazole

US Patents:	0
Tradenames:	8
Applicants:	32
NDAs:	45
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	45
Raw Ingredient (Bulk) Api Vendors:	158
Clinical Trials:	274
Patent Applications:	7,103
Drug Prices:	Drug price trends for fluconazole
Drug Sales Revenues:	Drug sales revenues for fluconazole
What excipients (inactive ingredients) are in fluconazole?	fluconazole excipients list
DailyMed Link:	fluconazole at DailyMed

See drug prices for fluconazole

See drug sales revenues for fluconazole

Recent Clinical Trials for fluconazole

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 clinical trials

Generic filers with tentative approvals for FLUCONAZOLE

Applicant	Application No.	Strength	Dosage Form
		200MG	TABLET;ORAL
		150MG	TABLET;ORAL
		100MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for fluconazole

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

Medical Subject Heading (MeSH) Categories for fluconazole

14-alpha Demethylase Inhibitors

Antifungal Agents

Cytochrome P-450 CYP2C19 Inhibitors

Cytochrome P-450 CYP2C9 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for fluconazole

D01AC	Imidazole and triazole derivatives
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

J02AC	Triazole and tetrazole derivatives
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for fluconazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Thinq Pharm-cro Pvt	FLUCONAZOLE	fluconazole	TABLET;ORAL	076957-001	Sep 28, 2005	AB	RX	No	No
Pfizer	DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER	fluconazole	INJECTABLE;INJECTION	019950-005	Jul 8, 1994		DISCN	Yes	No
Norvium Bioscience	FLUCONAZOLE	fluconazole	TABLET;ORAL	076351-002	Jul 29, 2004		DISCN	No	No
Ivax Sub Teva Pharms	FLUCONAZOLE	fluconazole	TABLET;ORAL	076077-003	Jul 29, 2004		DISCN	No	No
Aurobindo Pharma	FLUCONAZOLE	fluconazole	TABLET;ORAL	077731-003	Oct 7, 2008	AB	RX	No	No
Ani Pharms	FLUCONAZOLE	fluconazole	TABLET;ORAL	076086-003	Jul 29, 2004		DISCN	No	No
Mylan Pharms Inc	FLUCONAZOLE	fluconazole	TABLET;ORAL	076042-004	Jul 29, 2004		DISCN	No	No

Expired US Patents for fluconazole

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	019950-004	Jan 29, 1990
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-003	Jan 29, 1990
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-002	Jan 29, 1990
Pfizer	DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER	fluconazole	INJECTABLE;INJECTION	019950-003	Sep 29, 1992
Pfizer	DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	fluconazole	INJECTABLE;INJECTION	019950-002	Jan 29, 1990
Pfizer	DIFLUCAN	fluconazole	FOR SUSPENSION;ORAL	020090-001	Dec 23, 1993
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-003	Jan 29, 1990

Fluconazole Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fluconazole

Introduction

Fluconazole, a broad-spectrum antifungal agent, has been a cornerstone in the treatment of various fungal infections for decades. The market for fluconazole is experiencing significant growth, driven by several key factors. Here, we delve into the market dynamics and financial trajectory of fluconazole, highlighting the trends, drivers, and projections that shape its future.

Market Size and Growth Projections

The fluconazole market has demonstrated robust growth in recent years. As of 2023, the market size was valued at USD 4.56 billion and is expected to reach USD 7.38 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.1% from 2024 to 2031[1].

Drivers of Market Growth

Several factors are driving the growth of the fluconazole market:

Increasing Prevalence of Fungal Infections

The rising incidence of fungal infections, particularly among immunocompromised individuals such as those with HIV/AIDS or undergoing chemotherapy, is a major driver. According to the Centers for Disease Control and Prevention, there were over 75,000 hospitalizations and nearly 9 million outpatient visits for fungal diseases in the U.S. in 2017[3].

Broad-Spectrum Antifungal Action

Fluconazole's recognized efficacy as a first-line treatment for various fungal diseases, including invasive and superficial mycoses, supports its broad use in both hospital and outpatient settings[1].

Growing Elderly Population

The increasing number of elderly people worldwide, who are more vulnerable to fungal infections, is another significant factor driving demand for fluconazole[1].

Availability of Generic Versions

The availability of reasonably priced generic versions of fluconazole is increasing medicine accessibility, especially in developing nations, thereby fueling market growth[1].

Advances in Healthcare and Diagnostic Techniques

Improvements in diagnostic techniques and increased awareness of fungal infections are leading to earlier and more accurate diagnoses, which in turn drive the demand for effective treatments like fluconazole[2].

Regional Analysis

The fluconazole market is geographically diverse, with different regions exhibiting varying growth rates:

North America

North America is expected to account for a major share of the global fluconazole market, driven by the presence of key market players and a rise in the demand due to the prevalence of nosocomial infections[3].

Asia-Pacific

The Asia-Pacific region is projected to expand rapidly during the forecast period, driven by increasing awareness about fungal diseases and the growing need for antifungal treatments[3].

Other Regions

Regions such as the U.S., China, Japan, Canada, and Europe are also significant, with China forecasted to grow at an impressive 6.6% CAGR to reach $4.7 billion by 2030[2].

Market Segments

The fluconazole market can be segmented based on various factors:

Drug Class

The Azoles drug class, which includes fluconazole, is expected to reach US$10.7 billion by 2030, growing at a CAGR of 4.5%[2].

Form of the Drug

Fluconazole is available in various forms, including oral tablets, oral suspension, and solution for intravenous (IV) infusion. Each form has different market dynamics and cost implications[5].

Financial Trajectory

The financial trajectory of the fluconazole market is marked by significant growth:

Revenue Projections

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%[4].

Cost Factors

The cost of fluconazole can vary based on factors such as treatment plan, insurance coverage, and the pharmacy used. Generic versions and savings programs can significantly reduce the cost for patients[5].

Trends and Innovations

Several trends and innovations are shaping the future of the fluconazole market:

Advances in Nanotechnology and Drug Delivery Systems

Advances in nanotechnology and drug delivery systems are enhancing treatment efficacy and patient adherence, contributing to market growth[4].

Personalized Medicine and Telepharmacy Services

The integration of personalized medicine and telepharmacy services is expected to drive adoption and accessibility of fluconazole preparations[4].

Government Initiatives and Support

Government initiatives and support for preventive healthcare and antifungal therapies are also propelling market expansion[4].

Key Players

The global fluconazole market is highly concentrated, with several key players holding significant market shares:

Major Players

Companies such as Abbott Laboratories, Inc., Bayer AG, Enzon Pharmaceuticals, Inc., Gilead Sciences, Inc., and Pfizer, Inc. are among the leading players in the market[2].

Market Strategies

Industry players are adopting strategies such as appointing third-party distributors to expand their market presence, particularly in emerging markets[3].

Challenges and Restraints

Despite the growth, the fluconazole market faces some challenges:

Resistance and Side Effects

The development of resistance to fluconazole and potential side effects are concerns that need to be addressed through continuous research and development[2].

Regulatory Frameworks

Stringent regulatory frameworks can impact the approval and launch of new fluconazole preparations, affecting market growth[2].

Key Takeaways

• The fluconazole market is expected to grow significantly, driven by the increasing prevalence of fungal infections and the broad-spectrum antifungal action of the drug.
• The market is projected to reach USD 7.38 billion by 2031, growing at a CAGR of 6.1% from 2024 to 2031.
• Regional growth varies, with North America and Asia-Pacific being key regions.
• Advances in healthcare, diagnostic techniques, and drug delivery systems are enhancing market growth.
• Key players are adopting various strategies to expand their market presence.

FAQs

What are the primary drivers of the fluconazole market?

The primary drivers include the increasing prevalence of fungal infections, the broad-spectrum antifungal action of fluconazole, the growing elderly population, and the availability of generic versions.

How is the fluconazole market segmented?

The market can be segmented based on drug class, form of the drug, and geographic regions.

What is the projected growth rate of the fluconazole preparation market?

The fluconazole preparation market is projected to grow at a CAGR of 13.5% from 2023 to 2028.

Which regions are expected to drive the growth of the fluconazole market?

North America and the Asia-Pacific region are expected to be significant drivers of market growth.

What are the key trends shaping the future of the fluconazole market?

Key trends include advances in nanotechnology, personalized medicine, telepharmacy services, and government initiatives supporting preventive healthcare.

Sources

1. Market Research Intellect: Fluconazole Market Size, Share and Forecast to 2031.
2. GlobeNewswire: Antifungal Drugs Strategic Business Report 2024-2030.
3. BioSpace: Fluconazole Drugs Market: Increase in incidence of fungal infection is anticipated to boost the market.
4. EIN Presswire: Global Fluconazole Preparation Market Set For 13.5% Growth, Reaching $78.69 Billion By 2028.
5. Medical News Today: Fluconazole cost 2024: Savings tips and more.