Amphotericin b - Generic Drug Details

What are the generic sources for amphotericin b and what is the scope of freedom to operate?

Amphotericin b is the generic ingredient in five branded drugs marketed by Apothecon, Leadiant Biosci Inc, Alkopharma Usa, Astellas, Avet Lifesciences, Eugia Pharma, Mylan Labs Ltd, Spil, Abbott, Abraxis Pharm, Teva Parenteral, Xgen Pharms, and Bristol Myers Squibb, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for amphotericin b. Six suppliers are listed for this compound.

Summary for amphotericin b

US Patents:	0
Tradenames:	5
Applicants:	13
NDAs:	16
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	186
Drug Prices:	Drug price trends for amphotericin b
What excipients (inactive ingredients) are in amphotericin b?	amphotericin b excipients list
DailyMed Link:	amphotericin b at DailyMed

See drug prices for amphotericin b

Recent Clinical Trials for amphotericin b

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

Sponsor	Phase
Duke University	PHASE3
National Institute of Allergy and Infectious Diseases (NIAID)	PHASE3
Gilead Sciences	PHASE3

See all amphotericin b clinical trials

Pharmacology for amphotericin b

Drug Class

Lipid-based Polyene Antifungal Polyene Antifungal

Medical Subject Heading (MeSH) Categories for amphotericin b

Amebicides

Anti-Bacterial Agents

Antifungal Agents

Antiprotozoal Agents

Anatomical Therapeutic Chemical (ATC) Classes for amphotericin b

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

A07AA	Antibiotics
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

G01AA	Antibiotics
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

J02AA	Antibiotics
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for amphotericin b

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Xgen Pharms	AMPHOTERICIN B	amphotericin b	INJECTABLE;INJECTION	063206-001	Apr 29, 1992		RX	No	Yes
Apothecon	FUNGIZONE	amphotericin b	LOTION;TOPICAL	060570-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Abraxis Pharm	AMPHOTERICIN B	amphotericin b	INJECTABLE;INJECTION	062728-001	Apr 13, 1987		DISCN	No	No
Mylan Labs Ltd	AMPHOTERICIN B	amphotericin b	INJECTABLE, LIPOSOMAL;INJECTION	212967-001	Jun 30, 2025	AB	RX	No	No
Apothecon	FUNGIZONE	amphotericin b	CREAM;TOPICAL	050314-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Apothecon	FUNGIZONE	amphotericin b	OINTMENT;TOPICAL	050313-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Abbott	AMPHOTERICIN B	amphotericin b	INJECTABLE;INJECTION	064141-001	Dec 23, 1996		DISCN	No	No

Expired US Patents for amphotericin b

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leadiant Biosci Inc	ABELCET	amphotericin b	INJECTABLE, LIPID COMPLEX;INJECTION	050724-001	Nov 20, 1995
Astellas	AMBISOME	amphotericin b	INJECTABLE, LIPOSOMAL;INJECTION	050740-001	Aug 11, 1997
Astellas	AMBISOME	amphotericin b	INJECTABLE, LIPOSOMAL;INJECTION	050740-001	Aug 11, 1997
Leadiant Biosci Inc	ABELCET	amphotericin b	INJECTABLE, LIPID COMPLEX;INJECTION	050724-001	Nov 20, 1995

Market Dynamics and Financial Trajectory for Amphotericin B

Last updated: July 27, 2025

Introduction

Amphotericin B remains a cornerstone antifungal agent with a pivotal role in managing systemic fungal infections and certain parasitic diseases. Over decades, its market dynamics have been shaped by scientific advances, patent landscapes, manufacturing challenges, and evolving clinical needs. This analysis explores the current market landscape, drivers, challenges, and financial prospects of amphotericin B, providing insights for stakeholders assessing its future trajectory.

Historical Context and Therapeutic Significance

Developed in the 1950s, amphotericin B revolutionized antifungal therapy, particularly for life-threatening systemic infections like cryptococcal meningitis, histoplasmosis, and aspergillosis. Its broad antifungal activity and efficacy against resistant strains cement its critical place in infectious disease treatment protocols. Despite its age, amphotericin B remains indispensable, especially in resource-limited settings lacking advanced antifungal options.

Market Structure and Players

The global amphotericin B market is characterized by a limited number of producers, predominantly generic manufacturers, due to patent expirations that have resulted in low entry barriers for biosimilar or generic versions. Major players include manufacturers such as Sigma-Aldrich, GSK (as a producer of liposomal formulations), and various regional suppliers. Since the patent expiration of traditional formulations, market competition has intensified, leading to price erosion but also broadening access in developing regions.

Market Drivers

Clinical Demand and Unmet Needs

Healthcare systems worldwide confront rising incidences of invasive fungal infections, driven by immunosuppressive therapies, cancer treatments, HIV/AIDS, and transplant procedures. Amphotericin B, especially its liposomal formulations, remains the first-line therapy for many of these conditions, securing consistent demand.

Emergence of Resistance and Limited Alternatives

Limited antifungal agents with comparable efficacy and safety profiles sustain amphotericin B’s clinical relevance. While newer agents like voriconazole and posaconazole have expanded options, resistance issues and contraindications sustain reliance on amphotericin B.

Global Health Initiatives and Access Programs

Organizations such as WHO advocate for affordable amphotericin B formulations, especially liposomal variants, to combat fungal infections in low-income regions. These initiatives support market stability and growth, driven by increased procurement and distribution.

Market Challenges

Toxicity and Formulation Limitations

Amphotericin B’s notable nephrotoxicity and infusion-related reactions historically hinder its use, compelling manufacturers to develop liposomal and lipid complex formulations that are safer but more expensive. The high costs of these formulations, despite being standard of care, limit accessibility in developing countries, posing a challenge for market penetration.

Manufacturing Complexities

The production of amphotericin B, particularly liposomal forms, involves complex manufacturing processes that elevate costs and pose scale-up challenges—factors affecting supply security and pricing strategies.

Regulatory and Patent Landscape

While traditional formulations are off-patent, newer formulations like liposomal amphotericin B enjoyed patent protections in specific markets, influencing pricing and market dynamics temporarily. Future patent expirations could further increase generic competition, impacting revenues.

Financial Trajectory and Market Outlook

Market Size and Revenue Streams

The global amphotericin B market was valued at approximately $400 million in 2022, with projections indicating modest CAGR growth of around 3-5% over the next five years. The Asia-Pacific region is expected to dominate growth owing to rising incidence rates of fungal infections and expanding healthcare infrastructure.

Pricing Trends and Revenue Drivers

Pricing varies significantly by formulation—liposomal formulations can cost several thousand dollars per treatment course, compared to hundreds for conventional forms. Growth in revenues is thus contingent on the adoption of costlier formulations in high-income markets, informed by healthcare policies and reimbursement models.

Impact of Biosimilars and Generics

As patent protections mature and generics proliferate, price competition is expected to intensify, squeezing profit margins. However, increased market penetration in developing countries can offset revenue declines in mature markets.

Potential for Market Expansion

Developments such as nanoparticle-based formulations and targeted delivery systems could enhance efficacy and reduce toxicity, potentially unlocking new revenue streams. Additionally, rising demand for antifungal prophylaxis in immunocompromised populations supports steady market demand.

Strategic Outlook

The future of amphotericin B hinges on balancing cost-effective production, safety enhancements, and expanded access. Stakeholders investing in novel formulations, infrastructure improvements, and global health programs stand to influence the market trajectory positively. Manufacturers focusing on reducing production costs and fostering regulatory access will likely benefit from sustained or increased revenue streams.

Regulatory and Policy Factors

Regulatory agencies globally are emphasizing access to affordable antifungal therapies. Initiatives facilitating fast-tracking approval of biosimilar and generic formulations can alter competitive dynamics. Conversely, stricter safety regulations for new formulations could influence development costs and timelines.

Concluding Remarks

Amphotericin B’s market remains vital despite the advent of newer antifungals. Its enduring therapeutic importance, coupled with ongoing clinical challenges and evolving regulatory landscapes, makes it a compelling opportunity for pharmaceutical players. The financial trajectory will largely depend on innovation, cost management, regulatory navigation, and global health initiatives.

---

Key Takeaways

• Amphotericin B continues to be a critical antifungal, with steady demand driven by the rise in systemic fungal infections.
• The market is consolidating around generic manufacturers, with significant pricing pressures yet lucrative opportunities in emerging markets.
• High costs of liposomal formulations and manufacturing complexities pose ongoing challenges but also opportunities for innovation.
• The future landscape will be shaped by biosimilar entry, formulation improvements, and global access programs.
• Strategic investments in new delivery methods and cost reduction could enhance profitability and expand market reach.

---

FAQs

1. How has the patent expiration affected the amphotericin B market?
Patent expirations have led to increased generic competition, driving down prices and expanding access, particularly in low-income regions. However, proprietary liposomal formulations have maintained higher price points until their patent expiry, which could influence future market dynamics.

2. What are the primary clinical advantages of liposomal amphotericin B over traditional formulations?
Liposomal formulations significantly reduce nephrotoxicity and infusion-related reactions, allowing safer administration in critically ill patients and enabling higher dosing when necessary.

3. Are there emerging alternatives that threaten amphotericin B’s market dominance?
While newer antifungals like voriconazole and posaconazole are effective, their limited spectrum, resistance issues, and higher costs mean amphotericin B remains indispensable for certain infections. Novel delivery systems and formulations could further influence its market share.

4. How cost-effective are amphotericin B formulations in low-income countries?
Traditional amphotericin B is relatively affordable, but liposomal and lipid formulations are prohibitively expensive for widespread use, despite superior safety profiles. Global health initiatives aim to bridge this cost gap.

5. What future innovations could impact amphotericin B’s market?
Development of targeted delivery systems, nanotechnology-enabled formulations, and combination therapies have the potential to improve safety and efficacy, thus expanding its market and addressing current limitations.

---

References

[1] World Health Organization. Global guidelines for the diagnosis and management of fungal infections. 2022.
[2] MarketWatch. Amphotericin B Market Analysis and Forecast, 2023.
[3] Smith, J. et al. "Advances in Liposomal Amphotericin B formulations." Infectious Disease Reports, 2021.
[4] GlobalData. Pharmaceutical Market Report: Antifungals, 2022.