AMPHOTERICIN B - Generic Drug Details

What are the generic drug 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, Eugia Pharma, Spil, Abbott, Abraxis Pharm, Teva Parenteral, Xgen Pharms, and Bristol Myers Squibb, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for AMPHOTERICIN B

US Patents:	0
Tradenames:	5
Applicants:	11
NDAs:	14
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	170
Patent Applications:	6,746
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
Federal University of Health Science of Porto Alegre	Phase 3
Huashan Hospital	Phase 4
Helwan University	N/A

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
Bristol Myers Squibb	FUNGIZONE	amphotericin b	SUSPENSION;ORAL	050341-003	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
Alkopharma Usa	AMPHOTEC	amphotericin b	INJECTABLE, LIPID COMPLEX;INJECTION	050729-002	Nov 22, 1996		DISCN	No	No
Apothecon	FUNGIZONE	amphotericin b	LOTION;TOPICAL	060570-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Astellas	AMBISOME	amphotericin b	INJECTABLE, LIPOSOMAL;INJECTION	050740-001	Aug 11, 1997	AB	RX	Yes	Yes
Apothecon	FUNGIZONE	amphotericin b	CREAM;TOPICAL	050314-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Spil	AMPHOTERICIN B	amphotericin b	INJECTABLE, LIPOSOMAL;INJECTION	212514-001	Dec 14, 2021	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	5,616,334
Astellas	AMBISOME	amphotericin b	INJECTABLE, LIPOSOMAL;INJECTION	050740-001	Aug 11, 1997	5,965,156
Astellas	AMBISOME	amphotericin b	INJECTABLE, LIPOSOMAL;INJECTION	050740-001	Aug 11, 1997	5,874,104
Leadiant Biosci Inc	ABELCET	amphotericin b	INJECTABLE, LIPID COMPLEX;INJECTION	050724-001	Nov 20, 1995	6,406,713

AMPHOTERICIN B Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Amphotericin B

Introduction

Amphotericin B is a critical antifungal medication used to treat a wide range of fungal infections, particularly in immunocompromised patients. The market for Amphotericin B has been experiencing significant growth, driven by several key factors.

Market Size and Growth Projections

The global Amphotericin B market has shown substantial growth in recent years. As of 2022, the market size was valued at USD 0.22 billion and is projected to reach USD 0.30 billion by 2030, with a Compound Annual Growth Rate (CAGR) of 4.6% during the forecast period of 2023-2030[4].

Segmentation

The Amphotericin B market is segmented based on several criteria:

• Type: The market is categorized into different formulations such as 5Mg/Vial and 50Mg/Vial[1].
• Application: The primary applications include hospitals, clinics, and other healthcare settings[1].
• Route of Administration: The market includes intravenous, parenteral, oral, and other routes of administration. Notably, oral formulations like MAT2203 are emerging as significant alternatives to traditional IV administration[2][4].
• Geography: The market is analyzed across regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America dominates the market due to increasing healthcare initiatives and a strong presence of major players[1][4].

Drivers

Several factors drive the growth of the Amphotericin B market:

• Increase in Hospital-Acquired Infections (HAIs): HAIs contribute to a higher demand for antifungal medications like Amphotericin B. These infections are a significant challenge to patient care and overall healthcare systems[4].
• Rise in Fungal Infections: The global incidence of fungal infections is increasing, particularly among immunocompromised individuals, patients with chronic diseases, and those undergoing invasive medical procedures[4].
• Growing Healthcare Expenditure: Increased healthcare spending and government initiatives to combat fungal infections also drive market growth[4].

Challenges and Restraints

Despite the growth, the market faces several challenges:

• Toxicity Concerns: Traditional IV formulations of Amphotericin B are associated with significant side effects, including kidney damage, which can limit their use[2][3].
• Drug Resistance: The rise in antifungal drug resistance among fungal strains poses a challenge to the market[4].
• Side Effects: Common side effects such as blue lips, seizures, abdominal pain, and fever can also hamper market growth[4].

Opportunities

The market presents several opportunities for growth and innovation:

• Emerging Oral Formulations: Oral formulations like MAT2203, developed by Matinas BioPharma, offer a safer and more convenient alternative to IV administration. These formulations have shown promising clinical results with reduced toxicity and improved efficacy[2].
• Clinical Trials and R&D: Ongoing clinical trials and research activities are expected to provide beneficial opportunities for the market. For example, the Phase 3 registration trial of MAT2203 for the treatment of invasive aspergillus is set to commence in the second half of 2024[2].
• Growing Unhygienic Practices: Unfortunately, growing unhygienic practices in some regions can lead to an increase in fungal infections, thereby increasing the demand for Amphotericin B[4].

Key Players

The market is dominated by several key players:

• Gilead Sciences
• CSPC
• North China Pharmaceutical
• Shanghai Shanghai Pharmaceuticals New Asia Pharmaceutical Co. Ltd.
• Matinas BioPharma Holdings, Inc. (developer of MAT2203)[1][2].

Clinical Trials and Efficacy

Clinical trials have been instrumental in demonstrating the efficacy and safety of new Amphotericin B formulations. For instance, the NIH-funded trial evaluating MAT2203 in HIV-infected patients with cryptococcal meningitis showed significant improvements in survival rates and culture conversion compared to traditional IV-administered Amphotericin B[2].

Financial Impact

The financial trajectory of the Amphotericin B market is positive, with projected growth driven by increasing demand and the introduction of safer, more effective formulations. Here are some key financial insights:

• Market Value: The market is expected to grow from USD 0.22 billion in 2022 to USD 0.30 billion by 2030[4].
• Revenue Streams: Revenue is generated through various distribution channels, including hospital pharmacies, retail pharmacies, and online pharmacies[4].

Regional Analysis

The global Amphotericin B market is analyzed across various regions, with North America being the dominant market due to strong healthcare initiatives and the presence of major players. Other significant regions include Europe, Asia-Pacific, and the Middle East and Africa[1][4].

Pharmacoeconomic Analysis

Pharmacoeconomic studies highlight the economic benefits of using Amphotericin B formulations. For example, a study comparing liposomal Amphotericin B with voriconazole in patients with fever and neutropenia assessed the economic outcomes and found that the choice of antifungal therapy can significantly impact healthcare costs and patient outcomes[5].

Key Takeaways

• The Amphotericin B market is projected to grow significantly, driven by increasing cases of fungal infections and the development of safer oral formulations.
• Traditional IV formulations face challenges due to toxicity concerns, but emerging oral formulations like MAT2203 offer promising alternatives.
• Clinical trials and R&D activities are crucial for market growth and innovation.
• The market is dominated by key players, and regional analysis shows North America as the leading market.

FAQs

Q: What is the current market size of the Amphotericin B market? A: The current market size of the Amphotericin B market was valued at USD 0.22 billion in 2022[4].

Q: What is the projected growth rate of the Amphotericin B market? A: The market is expected to grow at a CAGR of 4.6% from 2023 to 2030[4].

Q: What are the main drivers of the Amphotericin B market? A: The main drivers include the increase in hospital-acquired infections, the rise in fungal infections, and growing healthcare expenditure[4].

Q: What are the challenges faced by the Amphotericin B market? A: The market faces challenges such as toxicity concerns, drug resistance, and side effects associated with traditional IV formulations[2][3][4].

Q: What are the emerging trends in the Amphotericin B market? A: Emerging trends include the development of oral formulations like MAT2203, which offer safer and more convenient alternatives to traditional IV administration[2].

Cited Sources

1. Market Research Intellect, "Amphotericin B Injection Market Size, Scope And Forecast Report", December 2024.
2. Matinas BioPharma Holdings, Inc., "MAT2203 :: Matinas BioPharma Holdings, Inc. (MTNB)".
3. MDPI, "Orally Administered Amphotericin B Nanoformulations", August 2022.
4. Data Bridge Market Research, "Amphotericin B Market Size, Demand & Revenue Forecast By 2030".
5. PubMed, "Pharmacoeconomic analysis of liposomal amphotericin B versus voriconazole in patients with fever and neutropenia", 2007.