ABELCET Drug Patent Profile

When do Abelcet patents expire, and what generic alternatives are available?

Abelcet is a drug marketed by Leadiant Biosci Inc and is included in one NDA.

The generic ingredient in ABELCET 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 Abelcet

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

Summary for ABELCET

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	3
Drug Prices:	Drug price information for ABELCET
What excipients (inactive ingredients) are in ABELCET?	ABELCET excipients list
DailyMed Link:	ABELCET at DailyMed

See drug prices for ABELCET

Recent Clinical Trials for ABELCET

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

Sponsor	Phase
Fundació Sant Joan de Déu	Phase 2
Ministry of Health, Spain	Phase 2
Enzon Pharmaceuticals, Inc.	Phase 3

See all ABELCET clinical trials

Pharmacology for ABELCET

Drug Class

Lipid-based Polyene Antifungal Polyene Antifungal

US Patents and Regulatory Information for ABELCET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Leadiant Biosci Inc	ABELCET	amphotericin b	INJECTABLE, LIPID COMPLEX;INJECTION	050724-001	Nov 20, 1995		RX	Yes	Yes

Expired US Patents for ABELCET

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
Leadiant Biosci Inc	ABELCET	amphotericin b	INJECTABLE, LIPID COMPLEX;INJECTION	050724-001	Nov 20, 1995

International Patents for ABELCET

See the table below for patents covering ABELCET around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	176010
South Africa	8801477
Australia	622405
Japan	H02502460
European Patent Office	0394265	PROCEDE DE SEPARATION GRANULOMETRIQUE DE PARTICULES. (METHOD FOR SIZE SEPARATION OF PARTICLES.)
New Zealand	223660	LOW TOXICITY DRUG-LIPID COMPLEXES; METHODS OF MAKING THEM; AND METHOD OF DETERMINING THEIR TOXICITY

ABELCET Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ABELCET

Introduction to ABELCET

ABELCET, also known as amphotericin B lipid complex (ABLC), is a formulation of the antifungal drug amphotericin B, designed to reduce the nephrotoxicity associated with conventional amphotericin B therapy. It is primarily used in hospitals to treat invasive fungal infections in immunocompromised patients.

Market Drivers

Several factors drive the demand for ABELCET:

Increase in Fungal Infections

The rise in fungal infections, particularly among immunocompromised patients such as those with cancer, HIV, or recipients of organ or bone marrow transplants, has increased the demand for effective antifungal treatments like ABELCET[3][5].

Hospital-Acquired Infections

Hospital-acquired infections (HAIs) also contribute to the demand for antifungal medications. HAIs can be caused by various pathogens, including fungi, and pose a significant challenge to patient care and healthcare systems[1].

Advantages Over Conventional Amphotericin B

ABELCET offers broad-spectrum efficacy similar to conventional amphotericin B but with significantly lower kidney toxicity. This makes it a preferred option for patients who are intolerant of or have failed conventional amphotericin B therapy[3][5].

Market Segmentation and Distribution

The market for ABELCET is segmented based on several factors:

Product Type

ABELCET falls under the category of lipid complex formulations of amphotericin B, which is distinct from other forms like static drops or atomization inhalation[1].

Application

It is used primarily for treating systemic fungal infections such as aspergillosis, which is a critical application given the life-threatening nature of these infections[4].

Route of Administration

ABELCET is administered intravenously, which is a common route for antifungal medications in hospital settings[1].

Distribution Channels

The drug is distributed through hospital pharmacies, retail pharmacies, and online pharmacies, with a strong presence in hospital settings due to its use in treating severe fungal infections[1].

Financial Performance and Trajectory

The financial performance of ABELCET is closely tied to its market dynamics and the overall strategy of the companies involved in its development and marketing.

Acquisition and Integration

Enzon Pharmaceuticals acquired the North American rights to ABELCET from Elan in 2002 for $360 million, along with the operating assets and a manufacturing facility. This acquisition was transformative for Enzon, shifting it from a royalty-based company to a product-based company[3][5].

Revenue and Sales

Following the acquisition, ABELCET contributed significantly to Enzon's revenue. For instance, in the fiscal year 2004, the sales guidance for ABELCET in North America was between $60-70 million, indicating a strong market presence[5].

Competitive Landscape

The market for hospital-based antifungal products is highly competitive. Despite this, Enzon's sales force successfully addressed competitive threats, leading to consistent month-to-month growth in prescriptions for ABELCET[5].

Impact on Company Financials

The acquisition and successful marketing of ABELCET significantly impacted Enzon's financials. By 2004, the products marketed by Enzon, including ABELCET, made up 56% of the company's revenues, up from 22% the previous year. This shift highlighted the company's transformation into a fully integrated biopharmaceutical company[5].

Challenges and Opportunities

While ABELCET has a strong market presence, there are challenges and opportunities to consider:

Challenges

• Nephrotoxicity Reduction: Although ABELCET reduces kidney toxicity compared to conventional amphotericin B, it still carries some risks and side effects, which can impact patient compliance and market growth[3].
• Competitive Pressure: The antifungal market is competitive, with new compounds and formulations entering the market, which can challenge ABELCET's market share[5].

Opportunities

• Growing Demand for Antifungals: The increasing incidence of fungal infections and the need for effective treatments provide ongoing opportunities for ABELCET[1].
• Strategic Transactions: Companies involved in the development and marketing of ABELCET can explore strategic transactions, such as licensing agreements and partnerships, to expand their market reach and product pipeline[3][5].

Regional Analysis

The global market for antifungal drugs, including ABELCET, varies by region:

North America

North America dominates the market due to increasing healthcare initiatives, a strong presence of major players, and rising cases of chronic fungal conditions[1].

Global Expansion

Companies like Enzon have rights to market ABELCET in various regions outside of North America, such as Japan, which provides additional market opportunities[3].

Key Takeaways

• Market Demand: Driven by the rise in fungal infections and hospital-acquired infections.
• Product Advantages: Lower kidney toxicity compared to conventional amphotericin B.
• Financial Impact: Significant revenue contributor to companies like Enzon Pharmaceuticals.
• Challenges: Competitive market and potential side effects.
• Opportunities: Growing demand for antifungals and strategic transactions.

FAQs

Q: What is ABELCET used for?

A: ABELCET is used to treat invasive fungal infections, particularly in immunocompromised patients who are intolerant of or have failed conventional amphotericin B therapy.

Q: How does ABELCET differ from conventional amphotericin B?

A: ABELCET is a lipid complex formulation that reduces the nephrotoxicity associated with conventional amphotericin B.

Q: Who acquired the rights to ABELCET in North America?

A: Enzon Pharmaceuticals acquired the North American rights to ABELCET from Elan in 2002.

Q: What was the financial impact of ABELCET on Enzon Pharmaceuticals?

A: ABELCET significantly contributed to Enzon's revenue, transforming the company from a royalty-based to a product-based company.

Q: What are the main challenges facing the market for ABELCET?

A: The main challenges include competitive pressure from new antifungal compounds and the potential side effects of the drug.

Cited Sources

1. Data Bridge Market Research - Global Amphotericin B Market Size, Demand & Revenue Forecast By 2030
2. AbCellera - Full Year 2023 Business Results
3. Enzon Pharmaceuticals - Acquisition of ABELCET Business
4. Medtech Citeline - THE LIPOSOME COMPANY's ABELCET (ABLC) GAINS APPROVAL FOR ASPERGILLOSIS IN SIX MONTHS
5. Enzon Pharmaceuticals, Inc. - Annual Reports - Management's Discussion and Analysis of Financial Condition and Results of Operations