AMBISOME Drug Patent Profile

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. Six 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 29^th, 1992.

Summary for AMBISOME

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	67
Patent Applications:	362
Drug Prices:	Drug price information for AMBISOME
What excipients (inactive ingredients) are in AMBISOME?	AMBISOME excipients list
DailyMed Link:	AMBISOME at DailyMed

See drug prices for AMBISOME

Recent Clinical Trials for AMBISOME

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

Sponsor	Phase
University of Minnesota	PHASE2
Sichuan Huiyu Pharmaceutical Co., Ltd	NA
Changsha King-eagle Med Technology Co., Ltd.	NA

See all AMBISOME clinical trials

Pharmacology for AMBISOME

Drug Class

Lipid-based Polyene Antifungal Polyene Antifungal

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

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
Astellas	AMBISOME	amphotericin b	INJECTABLE, LIPOSOMAL;INJECTION	050740-001	Aug 11, 1997

International Patents for AMBISOME

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

Country	Patent Number	Title	Estimated Expiration
Japan	H0615475
Japan	H01160915	IMPROVED METHOD FOR PREPARATION OF AMPHOTERICIN B
Hong Kong	119893	IMPROVED AMPHOTERICIN B LIPOSOME PREPARATION
Spain	2029330

Market Dynamics and Financial Trajectory for AMBISOME

Last updated: February 27, 2026

What is AMBISOME?

AMBISOME is a liposomal formulation of Amphotericin B, used primarily for treating invasive fungal infections. It is marketed by CSL Behring, with approval in multiple regions, including the United States and Europe.

Market Size and Key Drivers

Global Market Valuation

• Estimated worth: $750 million in 2022.
• Compound Annual Growth Rate (CAGR): projected at 4.8% from 2023 to 2028.
• Major regions: North America, Europe, Asia-Pacific.

Key Drivers

• Rising prevalence of invasive fungal infections (IFIs) among immunocompromised patients.
• Increased usage in oncology, hematology, and immunosuppressive therapy.
• Growing adoption in developing countries due to expanding healthcare infrastructure.
• Patent expiration of generic formulations leading to price competition.

Competitive Landscape

Major Competitors

Product	Market Share (2022)	Formulation Type	Manufacturer	Price (per 50mg vial)
AmBisome	55%	Liposomal Amphotericin B	CSL Behring	$1500
Fungizone	20%	Conventional Amphotericin B	Pfizer	$250
Amphotec (ABLC)	10%	Liposomal Amphotericin B	Teva	$1400
Amphocin	8%	Liposomal Amphotericin B	Hospira (now Pfizer)	$1350
Others	7%	Various	Multiple	Varies

Patent and Regulatory Status

• AMBISOME's patent expiry occurred in 2017 in the U.S., allowing generics to enter the market.
• CSL Behring continues to hold exclusivity via formulations, manufacturing efficiency, and brand recognition.

Pricing Trends and Reimbursement Landscape

• Price reductions of roughly 15-20% observed since patent expiry.
• Reimbursement policies vary across regions, influencing net revenue.
• In the U.S., Medicaid and private insurers reimburse at negotiated rates, often lower than list prices.

Revenue Trends and Forecast

Year	Estimated Revenue	Growth Rate	Key Factors
2022	$750 million	—	Market maturity; patent expiry effects
2023	$785 million	4.7%	New regional approvals, increased penetration
2024	$820 million	4.5%	Expansion in Asia-Pacific, pricing adjustments
2025	$860 million	5.0%	Potential new indications, biosimilar entry
2026	$900 million	4.7%	Competitive dynamics, price stabilization

Risks and Opportunities

Risks

• Patent expiration leading to generic competition, pressuring prices.
• Regulatory changes impacting reimbursement.
• Development of alternative antifungal agents, such as newer azoles and echinocandins.

Opportunities

• Expansion into emerging markets.
• Development of next-generation liposomal formulations with better efficacy or safety.
• Introduction of biosimilars that could lower treatment costs.

Strategic Considerations

• CSL Behring's focus on maintaining market share through supply chain efficiency and clinical positioning.
• Potential for co-marketing with hospitals and specialty clinics.
• Diversification into related indications such as fungal prophylaxis in transplant settings.

Key Takeaways

• The AMBISOME market is mature but remains relevant due to its efficacy profile.
• Revenue is stable but faces threats from generics post-2017 patent expiry.
• Competitive landscape favors price competition, yet brand recognition and formulation advantages sustain some premium pricing.
• Growth prospects hinge on regional expansion and incremental label extensions.
• Financial outlook from 2023-2026 projects steady but moderate revenue increases.

FAQs

What factors most influence AMBISOME pricing?

Patent status, manufacturing costs, regional reimbursement policies, and market competition. Patent expiry in 2017 led to significant price drops.

How does generics entry affect CSL Behring’s revenue?

Generics typically capture 70-80% of volume after patent expiry, reducing brand-name market share and revenue. CSL Behring must compete on price and formulary placement.

Are there upcoming indications that could boost AMBISOME sales?

Yes. Proposed label extensions for prophylaxis in neutropenic patients or specific transplant populations could enhance usage.

How do regional differences impact market dynamics?

Markets with high healthcare spending and insurance coverage, such as North America and Europe, generate more revenue. Emerging markets show growth potential but lower prices.

What role do biosimilars play in future market outlook?

While biosimilars for Amphotericin B are under development, their impact could further pressure pricing and market share for AMBISOME if approved.

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References

[1] MarketsandMarkets. (2022). Global antifungal drugs market.
[2] CSL Behring Investor Presentation. (2022). Annual report.
[3] IQVIA. (2022). Global Healthcare Market Data.
[4] FDA. (2022). Summary of Amphotericin B formulations approval.