FLUCYTOSINE - Generic Drug Details

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

Flucytosine is the generic ingredient in two branded drugs marketed by Bausch, Aurobindo Pharma Ltd, Hikma, Novel Labs Inc, Sigmapharm Labs Llc, and Strides Pharma, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for flucytosine. Eleven suppliers are listed for this compound.

Summary for FLUCYTOSINE

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	7
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	211
Clinical Trials:	35
Patent Applications:	7,391
Drug Prices:	Drug price trends for FLUCYTOSINE
What excipients (inactive ingredients) are in FLUCYTOSINE?	FLUCYTOSINE excipients list
DailyMed Link:	FLUCYTOSINE at DailyMed

See drug prices for FLUCYTOSINE

Recent Clinical Trials for FLUCYTOSINE

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

Sponsor	Phase
Huashan Hospital	Phase 4
University of Minnesota	Phase 3
Matinas BioPharma Nanotechnologies, Inc.	Phase 3

See all FLUCYTOSINE clinical trials

Pharmacology for FLUCYTOSINE

Drug Class

Nucleoside Analog Antifungal

Medical Subject Heading (MeSH) Categories for FLUCYTOSINE

Antifungal Agents

Antimetabolites

Anatomical Therapeutic Chemical (ATC) Classes for FLUCYTOSINE

D01AE	Other antifungals for topical use
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

J02AX	Other antimycotics for systemic use
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for FLUCYTOSINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Strides Pharma	FLUCYTOSINE	flucytosine	CAPSULE;ORAL	212632-002	Apr 17, 2020	AB	RX	No	No
Aurobindo Pharma Ltd	FLUCYTOSINE	flucytosine	CAPSULE;ORAL	213665-002	May 1, 2020	AB	RX	No	No
Strides Pharma	FLUCYTOSINE	flucytosine	CAPSULE;ORAL	207536-002	Jun 18, 2018		DISCN	No	No

FLUCYTOSINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Flucytosine

Introduction to Flucytosine

Flucytosine, an antifungal drug, is primarily used to treat serious fungal infections such as cryptococcal meningitis and candida infections. Understanding the market dynamics and financial trajectory of flucytosine is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Size and Growth Projections

The flucytosine tablets market has been experiencing significant growth in recent years. As of 2023, the market size was valued at several billion USD and is anticipated to expand substantially by 2031. The compound annual growth rate (CAGR) for the period from 2024 to 2031 is expected to be robust, driven by increasing demand for antifungal treatments[1][4].

Segmentation of the Market

The flucytosine market is segmented based on several key factors:

Type of Tablets

• The market is divided into 250 mg and 500 mg tablets, each catering to different treatment needs and patient populations[1][4].

Applications

• The primary applications include the treatment of cryptococcal meningitis and candida infections. These segments are critical in understanding the market's growth potential and the demand for flucytosine in various clinical settings[1][3].

Geographical Regions

• The market is analyzed across regions such as North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. North America currently holds a significant share of the global market, but other regions are expected to grow at a rapid pace due to increasing healthcare needs and improving economic conditions[1][4].

Drivers of Market Growth

Several factors are driving the growth of the flucytosine market:

Increasing Prevalence of Fungal Infections

• The rise in fungal infections, particularly among immunocompromised patients such as those with HIV/AIDS or undergoing chemotherapy, has increased the demand for effective antifungal treatments like flucytosine[3].

Advancements in Healthcare Infrastructure

• Improvements in healthcare infrastructure and access to medical services in developing regions are contributing to the growing demand for flucytosine and other antifungal drugs[4].

Government Initiatives and Policies

• Policies aimed at reducing the cost of essential medications and increasing access to healthcare are supporting the growth of the flucytosine market. For instance, initiatives to curb large price increases for medically important drugs can make flucytosine more affordable and accessible[2].

Challenges and Restraints

Despite the growth potential, the flucytosine market faces several challenges:

Price Volatility

• Flucytosine has experienced significant price fluctuations in the past. For example, between 2000 and 2019, the drug saw drastic price increases, which were later alleviated by subsequent price reductions attributed to market competition and regulatory actions[2].

Competition from Generic and Alternative Treatments

• The presence of generic versions of flucytosine and other antifungal drugs like amphotericin B and fluconazole can impact the market share of branded flucytosine products. Additionally, the development of new antifungal treatments poses a competitive threat[3].

Regulatory Environment

• The regulatory landscape, including FDA approvals and guidelines, can significantly influence the market dynamics of flucytosine. New approvals and changes in regulatory policies can affect the pricing and availability of the drug[2].

Competitive Landscape

The competitive landscape of the flucytosine market is characterized by the presence of several key players:

Major Pharmaceutical Companies

• Companies such as Pfizer Inc., Novartis AG, Sandoz (Novartis), Mylan N.V., Teva Pharmaceutical Industries Ltd., and others are prominent in the market. These companies engage in various strategies including product launches, partnerships, mergers, and acquisitions to maintain their market position[1].

Regional and Industry Presence

• The market is also influenced by the regional and industry presence of these companies. For instance, companies with a strong presence in North America and Europe often have a significant market share, but emerging players in Asia-Pacific and other regions are gaining traction[1][4].

Financial Performance and Pricing Analysis

The financial performance of the flucytosine market is closely tied to pricing dynamics:

Pricing Trends

• The wholesale acquisition cost of flucytosine has seen significant fluctuations. Despite initial drastic increases, subsequent reductions have made the drug more affordable. However, the cost remains a critical factor in the treatment of fungal infections, especially in low-income and middle-income countries[2].

Revenue and Growth Rate

• The revenue from flucytosine sales is expected to grow at a steady CAGR from 2024 to 2031. This growth is driven by increasing demand, improved market penetration, and the expansion of healthcare services in various regions[1][4].

Market Outlook and Future Prospects

The future outlook for the flucytosine market is promising:

Emerging Markets

• Regions such as Asia-Pacific and Latin America are expected to contribute significantly to the market growth due to their large patient populations and improving healthcare infrastructure[4].

New Developments and Innovations

• Continuous research and development in antifungal treatments, including new formulations and delivery methods, can further enhance the market growth of flucytosine[4].

Regulatory and Policy Support

• Supportive regulatory policies and initiatives aimed at reducing drug prices and improving access to healthcare will continue to play a crucial role in shaping the market dynamics of flucytosine[2].

Key Takeaways

• The flucytosine market is expected to grow significantly from 2024 to 2031, driven by increasing demand for antifungal treatments.
• The market is segmented by type, application, and geographical region, with North America currently holding a major share.
• Price volatility and competition from generic and alternative treatments are key challenges.
• Major pharmaceutical companies dominate the market, with emerging players gaining traction in various regions.
• Regulatory and policy support are crucial for the market's growth and affordability.

FAQs

Q: What are the primary applications of flucytosine?

• Flucytosine is primarily used to treat cryptococcal meningitis and candida infections.

Q: Which regions are expected to drive the growth of the flucytosine market?

• North America currently holds a significant share, but regions like Asia-Pacific and Latin America are expected to drive future growth.

Q: What are the major challenges facing the flucytosine market?

• Price volatility, competition from generic and alternative treatments, and regulatory changes are significant challenges.

Q: Who are the key players in the flucytosine market?

• Major players include Pfizer Inc., Novartis AG, Sandoz (Novartis), Mylan N.V., and Teva Pharmaceutical Industries Ltd.

Q: What is the expected CAGR for the flucytosine market from 2024 to 2031?

• The market is expected to grow at a robust CAGR, though the exact figure varies depending on the source and specific market conditions.

Citations

1. Market Research Intellect: "Flucytosine Tablets Sales Market Size, Scope And Forecast Report"
2. Wiley Online Library: "Antifungal drug price increases in the United States, 2000–2019"
3. Transparency Market Research: "Cryptococcosis Market | Global Analysis Report 2027"
4. Cognitive Market Research: "Flucytosine Tablets Market Report 2024 (Global Edition)"