AMPHOTERICIN B - Generic Drug Details

What are the generic sources for amphotericin b and what is the scope of patent protection?

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
National Hospital for Tropical Diseases, Hanoi, Vietnam	PHASE3
Bach Mai Hospital	PHASE3
Pham Ngoc Thach University of Medicine	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
Alkopharma Usa	AMPHOTEC	amphotericin b	INJECTABLE, LIPID COMPLEX;INJECTION	050729-002	Nov 22, 1996		DISCN	No	No
Teva Parenteral	AMPHOTERICIN B	amphotericin b	INJECTABLE;INJECTION	064062-001	Mar 31, 1995		DISCN	No	No
Apothecon	FUNGIZONE	amphotericin b	CREAM;TOPICAL	050314-001	Approved Prior to Jan 1, 1982		DISCN	No	No
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
Xgen Pharms	AMPHOTERICIN B	amphotericin b	INJECTABLE;INJECTION	063206-001	Apr 29, 1992		RX	No	Yes
Mylan Labs Ltd	AMPHOTERICIN B	amphotericin b	INJECTABLE, LIPOSOMAL;INJECTION	212967-001	Jun 30, 2025	AB	RX	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 of Amphotericin B

Last updated: December 18, 2025

Summary

Amphotericin B (AmB) remains a cornerstone antifungal agent since its initial approval in 1958. Despite its longstanding clinical use, recent market shifts are driven by emerging resistance, novel antifungal agents, manufacturing challenges, and evolving healthcare policies. This analysis explores the current market landscape, financial trajectories, competitive dynamics, regulatory environment, growth projections, and future opportunities for Amphotericin B, providing a comprehensive view for stakeholders across the pharmaceutical ecosystem.

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What Are the Core Market Drivers for Amphotericin B?

Historical Significance and Clinical Utility

Amphotericin B is a polyene macrolide antifungal, widely regarded for its broad spectrum activity against systemic fungal infections, including cryptococcal meningitis, histoplasmosis, and aspergillosis. Its inclusion in the World Health Organization's list of essential medicines underscores its critical role in global healthcare.

Market Drivers

Driver	Description	Impact Level
Rising Incidence of Fungal Infections	Increased immunocompromised populations (HIV/AIDS, transplant recipients)	High
Expanding Healthcare Infrastructure	Growth in hospital-acquired infections requiring antifungal treatment	Medium
Generic Availability	Availability of cost-effective formulations in developing regions	High
Barriers to Newer Drugs	Resistance, toxicity concerns, high costs limit novel antifungals' uptake	Medium
Emerging Resistance	Microbial resistance to azoles and echinocandins sustains demand	Medium

Market Challenges

• Toxicity Profile: Nephrotoxicity and infusion-related reactions restrict widespread use, prompting reliance on lipid-based formulations.
• Formulation Limitations: Liposomal and lipid complex formulations, more effective and safer, are costlier and face supply constraints.
• Patent and Regulatory Barriers: Limited patent protection encourages generic proliferation; however, regulatory hurdles influence market entry.

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What Is the Current Market Size and Financial Trajectory?

Global Market Valuation & Segmentation

Year	Estimated Market Size (USD billion)	Growth Rate (%)	Notes
2020	$1.4	3.8	Steady growth, driven by emerging markets
2021	$1.5	7.1	COVID-19 pandemic affects hospital use
2022	$1.6	6.7	Continued growth amid rising resistance
2023 (Projected)	$1.75	9.4	Increased adoption of lipid formulations

Source: Market research reports by Mordor Intelligence and GlobalData (2023).

Regional Market Breakdown

Region	Market Size (USD billion)	CAGR (2022-2028)	Major Factors
North America	$0.6	5.0%	Advanced healthcare infrastructure, high adoption of lipid formulations
Europe	$0.35	4.5%	Aging population, regulatory landscape
Asia-Pacific	$0.5	10.2%	Growing infectious disease burden, expanding healthcare access
Latin America	$0.2	4.2%	Rising prevalence of HIV-related infections
Middle East & Africa	$0.05	8.0%	Limited access but rising demand in tertiary care

Financial Outlook (2023–2028)

• Compound Annual Growth Rate (CAGR): Projected at 7-9%, driven predominantly by Asia-Pacific expansion and increased use of lipid formulations.
• Revenue Streams: Primarily from generic Liposomal Amphotericin B; branded formulations (Fungizone®) hold a niche share.
• Pricing Dynamics: Patient affordability, manufacturing costs, and patent expirations influence pricing strategies.

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How Do Regulatory Policies Impact Market Dynamics?

• Global Approvals: The WHO's Essential Medicines List promotes continued use in low-resource settings.
• FDA and EMA: Approvals of liposomal formulations (e.g., AmBisome®) have influenced market growth; regulatory preferences encourage safer formulations.
• Generic Entry Policy: Encourages lower prices and wider access but can depress overall market revenue.
• Biosimilar Development: Approval pathways for biosimilar liposomal Amphotericin B pursue expanded competition, impacting pricing and margins.

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What Are the Competitive Dynamics?

Key Players	Notable Products	Market Share	Strategic Focus
Gilead Sciences	AmBisome® (Liposomal Amphotericin B)	~60%	Innovation in lipid formulations, patents
Pfizer	Fungizone® (Deoxycholate Amphotericin B)	~20%	Cost-effective generic formulations
Other Generic Manufacturers	Various (Amphotericin B deoxycholate, liposomal generics)	20%	Cost competition, regional markets

Note: The market proportion is approximate, emphasizing Liposomal Amphotericin B dominance in developed economies.

What Are the Future Growth Opportunities?

Emerging Formulations and Delivery Modes

• Liposomal formulations with improved safety profiles.
• Thermoresponsive and targeted delivery mechanisms.
• Combination therapies to mitigate resistance and toxicity.

Expansion in Developing Markets

• Addressing unmet needs in HIV/AIDS, TB co-infections.
• Increasing availability of affordable formulations.

Technological Innovations

Innovation	Potential Impact
Nanoparticle Delivery	Enhanced targeting, reduced toxicity
Biosimilars	Lower-cost options, increased access
AI-driven Formulation Optimization	Faster development, tailored therapies

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Deep Dive: Regulatory Environment and Policy Influence

Region	Key Policies	Effect
United States	FDA approval processes for generics/biosimilars	Facilitates rapid market entry for low-cost options
European Union	EMA guidelines on lipid formulations	Encourages innovation in safer, higher-margin drugs
India (CDSCO)	Accelerated approvals for generics	Drives low-cost competition, expanding access
WHO	Essential Medicines List inclusion, guidelines	Promotes global adoption, especially in low-income regions

Comparison with Other Antifungals

Drug Class	Spectrum	Toxicity Profile	Cost Stability	Resistance Patterns
Polyenes (AmB)	Broad (systemic fungi)	High nephrotoxicity	Moderate (generics)	Low to moderate resistance
Azoles	Variable (species-specific)	Hepatotoxicity possible	Affordable	Growing resistance, cross-resistance
Echinocandins	Candida, Aspergillus	Well-tolerated	High	Resistance emerging with prolonged use

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Key Takeaways

• Amphotericin B retains a vital role in systemic fungal infection management amid rising resistance to newer agents.
• The lipid formulations, notably liposomal Amphotericin B, constitute a growth segment driven by safety improvements and regulatory endorsements.
• Market revenues are projected to grow at a CAGR of approximately 7–9% through 2028, fueled by expanding healthcare access in Asia-Pacific, especially in low- and middle-income countries.
• Patent expirations and biosimilar entries are expected to pressure prices but can also expand access, especially in underserved regions.
• Innovations in delivery and formulations represent significant opportunities to address toxicity and improve patient outcomes.

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FAQs

1. What are the main factors influencing Amphotericin B's market growth?
The key factors include increasing incidence of systemic fungal infections, growing use of lipid formulations for safety, emerging antifungal resistance, and expanding healthcare infrastructure in developing regions.

2. How do lipid-based formulations impact market dynamics?
Liposomal and lipid complex AmB formulations command higher prices due to superior safety profiles, thus creating a premium market segment and influencing overall revenue streams.

3. What challenges does Amphotericin B face from newer antifungals?
Emerging agents like echinocandins and azoles provide alternative options with better tolerability, risking market share especially where toxicity is a concern. Resistance development also pressures existing therapies.

4. How do regulatory policies affect Amphotericin B’s market?
Regulations favoring safer formulations and accelerated approval pathways in various regions facilitate wider access but may also accelerate generic entry, impacting margins.

5. What future innovations could alter Amphotericin B's market landscape?
Advancements include nanoparticle delivery, biosimilars, combination therapies, and precision drug delivery systems aiming to reduce toxicity and improve efficacy.

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References

[1] WHO Model List of Essential Medicines, 22nd Edition, 2023.
[2] Mordor Intelligence. Global Antifungal Market Report, 2023.
[3] GlobalData. Pharmaceutical Industry Outlook, 2023.
[4] U.S. Food and Drug Administration (FDA). Approvals and regulatory updates, 2022.
[5] European Medicines Agency (EMA). Pharmacovigilance and approval summaries, 2023.