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Last Updated: December 22, 2024

FUNGIZONE Drug Patent Profile


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When do Fungizone patents expire, and when can generic versions of Fungizone launch?

Fungizone is a drug marketed by Apothecon and Bristol Myers Squibb and is included in five NDAs.

The generic ingredient in FUNGIZONE is amphotericin b. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amphotericin b profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Fungizone

A generic version of FUNGIZONE was approved as amphotericin b by XGEN PHARMS on April 29th, 1992.

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Summary for FUNGIZONE
Drug patent expirations by year for FUNGIZONE
Recent Clinical Trials for FUNGIZONE

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

SponsorPhase
Ukrainian Medical Stomatological AcademyN/A
University of ManitobaPhase 4
PfizerPhase 4

See all FUNGIZONE clinical trials

US Patents and Regulatory Information for FUNGIZONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apothecon FUNGIZONE amphotericin b CREAM;TOPICAL 050314-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apothecon FUNGIZONE amphotericin b OINTMENT;TOPICAL 050313-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apothecon FUNGIZONE amphotericin b INJECTABLE;INJECTION 060517-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apothecon FUNGIZONE amphotericin b LOTION;TOPICAL 060570-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol Myers Squibb FUNGIZONE amphotericin b SUSPENSION;ORAL 050341-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

FUNGIZONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fungizone and the Antifungal Drugs Market

Introduction to Fungizone

Fungizone, also known as Amphotericin B, is a potent antifungal polyene antibiotic used primarily for the treatment of progressive and potentially life-threatening fungal infections. It is administered intravenously and is crucial in managing severe fungal infections such as aspergillosis, cryptococcosis, and systemic candidiasis[2].

Global Antifungal Drugs Market Overview

The global antifungal drugs market is experiencing significant growth, driven by several key factors. Here are some of the main dynamics influencing this market:

Market Size and Growth

The global antifungal drugs market was estimated at $16.5 billion in 2023 and is projected to reach $22 billion by 2030, growing at a CAGR of 4.2% from 2023 to 2030[1].

Drivers of Market Growth

  • Increasing Prevalence of Fungal Infections: The rising incidence of fungal infections, particularly among immunocompromised individuals and the elderly, is a major driver of the market[1][3].
  • Technological Advancements: Advances in antifungal drug formulations and delivery systems are enhancing treatment efficacy and patient adherence, contributing to market growth[1].
  • Prophylactic Use: The integration of antifungal drugs in comprehensive care plans for chronic diseases and the rising trend of prophylactic antifungal use in high-risk populations are further supporting market expansion[1].

Regional Analysis

  • North America: This region leads the market with a dominant share due to extensive research and development in the U.S. and the presence of major market players[3][4].
  • Asia-Pacific: Expected to register substantial growth, driven by the burgeoning consumer base in densely populated and swiftly developing economies like India and China[3][4].

Segmentation of the Antifungal Drugs Market

Drug Classes

  • Azoles: Dominant segment with about 50% of the revenue share due to their broad spectrum of activity and effectiveness in treating various fungal infections. Azoles are expected to reach $10.7 billion by 2030 with a CAGR of 4.5%[1][4].
  • Polyenes: Fungizone, an example of a polyene antifungal, is critical for treating severe and life-threatening infections. While not the largest segment, polyenes remain essential due to their efficacy against resistant strains[2].
  • Echinocandins: Expected to grow at a CAGR of 3.9% over the analysis period, echinocandins are another significant class of antifungal drugs[1].
  • Allylamines: Expected to grow at the fastest CAGR of 6.64% from 2024 to 2032, driven by their potent antifungal action and fewer side effects[4].

Financial Trajectory for Fungizone

Market Position

While specific financial data for Fungizone alone is not readily available, its position within the broader antifungal drugs market is significant. As a key treatment for severe fungal infections, Fungizone contributes to the overall growth of the polyene segment.

Revenue Contribution

The polyene segment, which includes Fungizone, benefits from the increasing demand for effective treatments against life-threatening fungal infections. The growth of this segment is tied to the overall market growth, with the antifungal drugs market expected to reach $22 billion by 2030[1].

Cost and Accessibility

Fungizone is a critical but expensive treatment option, which can be a barrier to access in some regions. However, its importance in treating severe infections ensures a steady demand, despite the high cost and potential side effects[2][3].

Challenges and Opportunities

Challenges

  • Resistance and Side Effects: The diminishing efficacy of antifungal drugs due to increasing resistance developed by fungi and the side effects associated with these drugs are significant challenges[3].
  • Expensiveness: The high cost of antifungal treatments, including Fungizone, can limit access, especially in developing economies[3].

Opportunities

  • Technological Advancements: Continued advancements in diagnostic techniques and drug formulations offer opportunities for improved treatment efficacy and patient adherence[1][3].
  • Growing Healthcare Budgets: Increasing healthcare budgets in developing economies and favorable government initiatives are expected to boost the market[3].

Key Takeaways

  • The global antifungal drugs market is growing at a CAGR of 4.2% from 2023 to 2030.
  • Fungizone, as part of the polyene segment, plays a crucial role in treating severe fungal infections.
  • The market is driven by increasing prevalence of fungal infections, technological advancements, and prophylactic use in high-risk populations.
  • Regional growth is led by North America, with significant potential in the Asia-Pacific region.
  • Challenges include drug resistance, side effects, and expensiveness, while opportunities lie in technological advancements and growing healthcare budgets.

FAQs

1. What is the projected market size of the global antifungal drugs market by 2030?

The global antifungal drugs market is projected to reach $22 billion by 2030[1].

2. Which drug class dominates the antifungal drugs market?

The azoles class dominates the market with about 50% of the revenue share[1][4].

3. What are the main drivers of the antifungal drugs market?

The main drivers include the increasing prevalence of fungal infections, technological advancements, and the rising trend of prophylactic antifungal use in high-risk populations[1][3].

4. Which region is expected to show the fastest growth in the antifungal drugs market?

The Asia-Pacific region is expected to register substantial growth, driven by the burgeoning consumer base in densely populated and swiftly developing economies like India and China[3][4].

5. What are the challenges faced by the antifungal drugs market?

Challenges include the diminishing efficacy of antifungal drugs due to increasing resistance, side effects, and the expensiveness of treatments[3].

Cited Sources:

  1. GlobeNewswire: "Antifungal Drugs - Global Strategic Business Report 2024-2030"
  2. Drugs.com: "Fungizone: Package Insert / Prescribing Information"
  3. Biospace: "Antifungal Drugs Market: Trends, Opportunities & Regional Outlook"
  4. SNS Insider: "Anti-Fungal Treatment Market Size, Share & Trends by 2032"

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