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Last Updated: December 22, 2024

AMBISOME Drug Patent Profile


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Which patents cover Ambisome, and what generic alternatives are available?

Ambisome is a drug marketed by Astellas and is included in one NDA.

The generic ingredient in AMBISOME 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 Ambisome

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

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Summary for AMBISOME
Drug patent expirations by year for AMBISOME
Drug Prices for AMBISOME

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Recent Clinical Trials for AMBISOME

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

SponsorPhase
F2G Biotech GmbHPhase 3
Iqvia Pty LtdPhase 3
Dongkook Pharmaceutical Co., Ltd.Phase 1

See all AMBISOME clinical trials

Pharmacology for AMBISOME

US Patents and Regulatory Information for AMBISOME

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astellas AMBISOME amphotericin b INJECTABLE, LIPOSOMAL;INJECTION 050740-001 Aug 11, 1997 AB RX Yes Yes ⤷  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

Expired US Patents for AMBISOME

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astellas AMBISOME amphotericin b INJECTABLE, LIPOSOMAL;INJECTION 050740-001 Aug 11, 1997 ⤷  Subscribe ⤷  Subscribe
Astellas AMBISOME amphotericin b INJECTABLE, LIPOSOMAL;INJECTION 050740-001 Aug 11, 1997 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

AMBISOME Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for AMBISOME

Introduction

AMBISOME, a liposomal formulation of the antifungal medication Amphotericin B, is a critical treatment for serious fungal infections, particularly in immunocompromised patients. The market dynamics and financial trajectory of AMBISOME are influenced by several key factors, including regulatory support, technological advancements, healthcare infrastructure, and competitive pressures.

Regulatory Landscape

The regulatory environment plays a significant role in the growth of the AMBISOME market. Regulatory agencies such as the FDA and EMA have introduced programs like breakthrough therapy and orphan drug designations to expedite the approval of drugs targeting serious fungal infections. These programs reduce the timeline for market entry and provide financial incentives, such as tax credits and waived user fees, which are crucial for the development and commercialization of AMBISOME[1].

Advancements in Drug Formulation Technologies

Advancements in drug formulation technologies have enhanced the efficacy and safety profile of AMBISOME. The liposomal formulation reduces the nephrotoxicity associated with conventional Amphotericin B, making it a more favorable option for patients. This reduction in nephrotoxicity not only improves patient outcomes but also lowers hospital costs, as evidenced by a pharmacoeconomic study that found AMBISOME to be more cost-effective than Abelcet due to reduced treatment-related nephrotoxicity[2].

Healthcare Infrastructure and Emerging Markets

The expansion of healthcare infrastructure in emerging markets is a significant driver for the AMBISOME market. Countries experiencing economic growth are investing heavily in healthcare, improving access to essential medicines and modern healthcare facilities. This increased access leads to a higher diagnosis and treatment rate of serious infections, including fungal infections, thereby fueling the growth of the AMBISOME market[1].

High Cost of Treatment

Despite its benefits, the high cost of AMBISOME is a significant restraint on its market growth. The financial burden associated with this treatment can limit accessibility, especially in lower-income regions and countries without adequate healthcare coverage. This cost can lead to patient non-compliance and may prompt healthcare providers to opt for less expensive alternatives, complicating market penetration[1].

Limited Indications and Generic Competition

AMBISOME faces challenges due to its limited indications and the presence of generic formulations. As patents for branded drugs expire, generic versions are introduced, offering similar efficacy at a lower cost. This competition pressures the pricing strategies of AMBISOME and influences physician prescribing habits, potentially diminishing its market share[1].

Global Market Segmentation

The global AMBISOME market is segmented by geography, with key regions including North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. Each region presents unique healthcare dynamics and market opportunities. For instance, North America and Europe have high accessibility to healthcare facilities and innovative treatment protocols, while the Asia-Pacific region shows rapid growth due to rising healthcare expenditures and a growing population at risk of fungal infections[1].

Key Players

The AMBISOME market is dominated by several major players, including Gilead Sciences, Cipla, Bristol-Myers Squibb Company, Matinas Biopharma Holdings, and others. These companies play a crucial role in driving innovation, marketing strategies, and distribution channels for AMBISOME[1].

Financial Trajectory

The financial trajectory of AMBISOME is expected to be positive, driven by several factors. The global Amphotericin B market, which includes AMBISOME, was valued at USD 0.22 billion in 2022 and is expected to grow to USD 0.30 billion by 2030, with a CAGR of 4.6% during the forecast period. This growth is attributed to the rising prevalence of fungal infections, increasing healthcare expenditures, and growing government initiatives for spreading awareness about antifungal treatments[4].

Cost-Effectiveness

Studies have shown that AMBISOME is cost-effective compared to other antifungal treatments. A pharmacoeconomic study found that AMBISOME at a dose of 3 mg/kg/day was more cost-effective than Abelcet due to reduced nephrotoxicity and associated hospital costs. This cost-effectiveness is a significant financial advantage, especially in the context of rising healthcare costs[2].

Market Growth Drivers

  • Rising Prevalence of Fungal Infections: The increasing incidence of fungal infections, particularly in immunocompromised patients, drives the demand for effective antifungal treatments like AMBISOME[4].
  • Emerging Markets: The expansion of healthcare infrastructure in emerging markets increases access to modern healthcare facilities and essential medicines, boosting the market for AMBISOME[1].
  • Regulatory Support: Favorable regulatory environments and financial incentives support the development and commercialization of AMBISOME[1].

Market Challenges

  • High Treatment Costs: The high cost of AMBISOME limits its accessibility, especially in lower-income regions, and may lead to patient non-compliance and preference for cheaper alternatives[1].
  • Generic Competition: The presence of generic formulations poses a significant challenge to the market share of AMBISOME, as generics offer similar efficacy at lower costs[1].

Conclusion

The market dynamics and financial trajectory of AMBISOME are shaped by a combination of regulatory support, technological advancements, healthcare infrastructure expansion, and competitive pressures. Despite challenges such as high treatment costs and generic competition, the market is expected to grow significantly, driven by the rising prevalence of fungal infections and supportive regulatory environments.

Key Takeaways

  • Regulatory Support: Favorable regulatory programs expedite market entry and provide financial incentives.
  • Technological Advancements: Liposomal formulation reduces nephrotoxicity and improves cost-effectiveness.
  • Healthcare Infrastructure: Expansion in emerging markets increases access to essential medicines.
  • High Treatment Costs: Limits accessibility and may lead to patient non-compliance.
  • Generic Competition: Pressures pricing strategies and influences prescribing habits.
  • Financial Trajectory: Expected growth driven by rising fungal infection prevalence and healthcare expenditures.

FAQs

Q: What are the key drivers of the AMBISOME market?

A: The key drivers include regulatory support, advancements in drug formulation technologies, expansion of healthcare infrastructure in emerging markets, and the rising prevalence of fungal infections.

Q: How does the high cost of AMBISOME affect its market?

A: The high cost limits accessibility, especially in lower-income regions, and may lead to patient non-compliance and preference for cheaper alternatives.

Q: What is the impact of generic competition on AMBISOME?

A: Generic formulations offer similar efficacy at lower costs, pressuring the pricing strategies of AMBISOME and influencing physician prescribing habits, potentially diminishing its market share.

Q: Which regions show the most promising growth for AMBISOME?

A: The Asia-Pacific region shows rapid growth due to rising healthcare expenditures and a growing population at risk of fungal infections.

Q: What is the expected financial growth of the AMBISOME market?

A: The global Amphotericin B market, including AMBISOME, is expected to grow from USD 0.22 billion in 2022 to USD 0.30 billion by 2030, with a CAGR of 4.6% during the forecast period.

Sources

  1. Verified Market Research: Ambisome Market Size, Scope, Growth, Trends and Forecast.
  2. Gilead Sciences: Pharmacoeconomic Study Compares Total Hospital Costs of AmBisome to Abelcet for Empirical Treatment of Patients with Febrile Neutropenia.
  3. GlobeNewswire: Global Mucormycosis Treatment Market is estimated to be US$ 822.0 million by 2030 with a CAGR of 7.5 during the forecast period.
  4. Data Bridge Market Research: Amphotericin B Market Size, Demand & Revenue Forecast By 2030.
  5. PLOS Neglected Tropical Diseases: A randomized trial of AmBisome monotherapy and AmBisome and miltefosine combination to treat visceral leishmaniasis in HIV co-infected patients in Ethiopia.

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