FUNGIZONE Drug Patent Profile
When do Fungizone patents expire, and when can generic versions of Fungizone launch?
Fungizone is a drug marketed by Apothecon and Bristol Myers Squibb and is included in five NDAs.
The generic ingredient in FUNGIZONE is amphotericin b. There is one drug master file entry 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 Fungizone
A generic version of FUNGIZONE was approved as amphotericin b by XGEN PHARMS on April 29th, 1992.
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Summary for FUNGIZONE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 9 |
| Patent Applications: | 4,852 |
| DailyMed Link: | FUNGIZONE at DailyMed |
Recent Clinical Trials for FUNGIZONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ukrainian Medical Stomatological Academy | N/A |
| University of Manitoba | Phase 4 |
| Pfizer | Phase 4 |
US Patents and Regulatory Information for FUNGIZONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apothecon | FUNGIZONE | amphotericin b | CREAM;TOPICAL | 050314-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Apothecon | FUNGIZONE | amphotericin b | OINTMENT;TOPICAL | 050313-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Apothecon | FUNGIZONE | amphotericin b | INJECTABLE;INJECTION | 060517-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Apothecon | FUNGIZONE | amphotericin b | LOTION;TOPICAL | 060570-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Bristol Myers Squibb | FUNGIZONE | amphotericin b | SUSPENSION;ORAL | 050341-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Fungizone Market Dynamics, Patent Status, FDA Exclusivity, and Financial Trajectory
Fungizone is the historical brand name for conventional amphotericin B deoxycholate, an intravenous antifungal used for severe systemic fungal infections. Its commercial position has declined because of nephrotoxicity, infusion-related reactions, and substitution by liposomal amphotericin B and other lipid formulations. The product has no meaningful modern patent moat, no remaining regulatory exclusivity, and limited standalone financial disclosure. Its economic value persists mainly in hospital formulary niches, low-cost procurement, and settings where lipid formulations are unavailable or unaffordable.
What is Fungizone and who manufactures it?
Fungizone contains amphotericin B deoxycholate for intravenous administration. The conventional formulation is supplied as a sterile powder that is reconstituted and diluted before infusion. The historical U.S. product was associated with Bristol-Myers Squibb and its predecessors. Current U.S. supply is primarily provided through generic manufacturers and distributors rather than through a branded Fungizone franchise.
| Attribute | Fungizone profile |
|---|---|
| Active ingredient | Amphotericin B deoxycholate |
| Route | Intravenous infusion |
| Common vial strength | 50 mg |
| Primary use | Serious systemic and invasive fungal infections |
| Original innovator | Squibb/Bristol-Myers Squibb lineage |
| Current U.S. commercial model | Generic hospital supply |
| FDA pathway | Abbreviated New Drug Application and legacy approval pathways |
| Patent position | No material active composition patent protection |
| Regulatory exclusivity | Expired |
| Principal substitutes | Liposomal amphotericin B, amphotericin B lipid complex, azole antifungals, echinocandins |
The product is pharmacologically distinct from liposomal amphotericin B, marketed as AmBisome, and from amphotericin B lipid complex, marketed as Abelcet. These products are not generic equivalents of Fungizone because their delivery systems and clinical exposure profiles differ.
What is the FDA regulatory status of Fungizone?
Fungizone’s original regulatory exclusivity has expired. Conventional amphotericin B is an established injectable product with generic competition and no new-drug exclusivity supporting current commercial pricing.
FDA labeling identifies amphotericin B deoxycholate as a treatment for serious, potentially life-threatening fungal infections. The drug is generally reserved for patients who require systemic therapy because its toxicity profile limits routine use. Renal impairment, electrolyte abnormalities, anemia, fever, chills, and infusion reactions are key safety considerations. [1]
The FDA’s regulatory framework treats conventional amphotericin B and lipid-based formulations as separate products. A generic manufacturer seeking approval for amphotericin B deoxycholate does not automatically gain substitution rights for AmBisome or Abelcet. Product-specific approval, formulation, clinical, and manufacturing requirements remain relevant.
Does Fungizone have FDA exclusivity?
No current FDA exclusivity materially protects Fungizone. Any historical new-drug exclusivity expired decades ago. The product is now exposed to generic competition and hospital purchasing pressure.
The FDA’s Orange Book does not create a durable commercial barrier for an old injectable active ingredient when patent and exclusivity terms have expired. Generic applicants can compete through abbreviated applications if they satisfy quality, bioequivalence, sterility, and manufacturing requirements. [2]
What patents protect Fungizone?
No active composition-of-matter patent is commercially relevant to conventional amphotericin B deoxycholate. Amphotericin B was discovered in the 1950s, placing the original molecule far beyond the term of any historical compound patent.
The remaining intellectual-property issues are more likely to involve:
- Manufacturing processes
- Drug-release or infusion systems
- Lipid or liposomal delivery technologies
- Stabilizers and excipients
- Packaging and reconstitution systems
- Use patents for newer formulations or combinations
These rights generally do not block manufacture of conventional amphotericin B deoxycholate when the generic product does not practice the protected formulation or delivery technology.
What formulation patents affect amphotericin B?
The most commercially important formulation IP has historically covered lipid-based delivery systems rather than Fungizone itself. Liposomal amphotericin B was developed to improve tolerability and alter distribution while retaining antifungal activity. Such formulations can carry separate patents, regulatory exclusivity, manufacturing know-how, and process controls.
This distinction creates two separate markets:
| Market | Product type | IP and commercial profile |
|---|---|---|
| Conventional amphotericin B | Deoxycholate formulation | Mature generic market, low patent protection |
| Liposomal amphotericin B | Liposome-encapsulated formulation | Higher manufacturing complexity and stronger historical product differentiation |
| Lipid complex amphotericin B | Lipid-complex formulation | Separate product approval and formulation know-how |
| Oral antifungals | Azoles and other agents | Different route, spectrum, safety, and resistance profile |
When did Fungizone lose market exclusivity?
Fungizone lost meaningful exclusivity long before the modern generic-drug market. The original drug was introduced in the late 1950s, and its compound patent and regulatory protection are no longer relevant to present-day competition.
There is no credible current exclusivity date that would delay generic entry. Generic competition is already established. Any commercial protection today would have to arise from supply reliability, manufacturing approvals, hospital contracts, or temporary shortages rather than from patents.
Fungizone exclusivity timeline
| Period | Commercial event |
|---|---|
| 1950s | Amphotericin B discovered and developed for systemic fungal disease |
| Late 1950s | Conventional amphotericin B introduced commercially |
| Subsequent decades | Generic and alternative amphotericin products enter the market |
| 1990s onward | Liposomal and lipid-complex formulations gain use where toxicity reduction is important |
| Current market | Conventional product competes primarily on price and availability |
How strong is the Fungizone patent estate?
The patent estate is weak for conventional amphotericin B deoxycholate. Its competitive position is based on legacy clinical familiarity and manufacturing execution, not exclusivity.
A practical assessment is:
| Patent factor | Assessment |
|---|---|
| Active ingredient patent | None of meaningful current value |
| Basic formulation patent | Expired or commercially nonblocking |
| Method-of-use protection | No material current barrier for standard indications |
| Manufacturing patents | Possible at supplier level, but not a broad Fungizone monopoly |
| Orange Book patent protection | No meaningful barrier expected |
| Generic vulnerability | High |
| Biosimilar vulnerability | Not applicable |
The product’s manufacturing process still presents technical barriers. Amphotericin B is poorly water soluble and requires careful formulation, sterile processing, reconstitution instructions, impurity control, and stability testing. These requirements can limit the number of reliable suppliers even when the legal patent barrier is absent.
What is the market position of Fungizone versus AmBisome?
AmBisome has largely displaced conventional amphotericin B in many high-income-country settings when clinicians prioritize reduced nephrotoxicity and improved tolerability. Fungizone retains a role where acquisition cost, availability, or local treatment protocols favor the conventional product.
| Factor | Fungizone | AmBisome |
|---|---|---|
| Formulation | Deoxycholate | Liposomal |
| Patent position | Mature, largely unprotected | Historically stronger formulation and process protection |
| Renal toxicity | Higher | Lower relative to conventional amphotericin B |
| Infusion reactions | More frequent | Generally reduced, but still possible |
| Acquisition cost | Lower | Higher |
| Manufacturing complexity | Moderate to high | High |
| Hospital use | Resource-constrained or selected cases | Broad use in severe infections where tolerability matters |
| Generic substitution | More established | More limited and technically difficult |
| Commercial pricing power | Low | Higher than conventional formulation |
Clinical guidelines frequently favor liposomal amphotericin B in serious infections when toxicity and clinical risk justify the cost. For example, treatment recommendations for invasive fungal disease and cryptococcal meningitis have supported lipid formulations in important patient populations. [3,4]
What are the main market drivers for Fungizone?
Fungizone demand is shaped by clinical need, health-system economics, and supply conditions.
Clinical demand
Demand persists in:
- Invasive candidiasis and other serious fungal infections
- Cryptococcal disease
- Mucormycosis
- Visceral leishmaniasis in selected settings
- Empiric treatment of high-risk febrile neutropenia in certain protocols
- Regions with limited access to lipid formulations
Use is constrained by nephrotoxicity and the availability of azoles, echinocandins, and newer antifungal agents.
Procurement economics
Conventional amphotericin B has a lower drug acquisition cost than liposomal amphotericin B. Hospitals may use it when:
- Budgets are constrained
- Liposomal product is unavailable
- Treatment protocols accept the renal-risk tradeoff
- The patient has no suitable alternative
- Public-health programs use standardized low-cost regimens
The low unit price does not eliminate total treatment cost. Renal monitoring, electrolyte replacement, hospitalization, infusion management, and treatment of adverse events can increase the overall cost of therapy.
Supply reliability
Sterile injectable antifungals are vulnerable to manufacturing interruptions. A small number of approved suppliers, complex sterile production, and low-margin pricing can reduce supplier participation. Shortages can produce temporary price increases or cause hospitals to shift between conventional and lipid formulations.
Are there Paragraph IV challenges involving Fungizone?
Paragraph IV litigation is not a material current issue for conventional Fungizone. Paragraph IV certifications target listed patents associated with an approved reference product. Because the relevant conventional amphotericin B patents are expired or commercially inactive, a modern generic challenge is unlikely to create a significant litigation event.
The more relevant patent disputes have historically concerned newer amphotericin formulations, delivery technologies, or manufacturing processes. Those disputes are distinct from generic entry into conventional amphotericin B deoxycholate.
What litigation and settlement agreements affect Fungizone?
No major current litigation or settlement agreement appears to define the commercial outlook for conventional Fungizone. The product’s competitive pressure is structural rather than litigation-driven.
Potential disputes in the broader amphotericin market could involve:
- Liposomal formulation patents
- Process patents
- ANDA approval timing
- Product labeling
- Distribution agreements
- Drug-shortage allocation
- Manufacturing quality issues
Those disputes would affect competing formulations or individual suppliers rather than restore exclusivity to Fungizone.
Is there biosimilar risk for Fungizone?
No. Fungizone is a small-molecule antifungal, not a biologic. The relevant competitive pathway is generic approval, not biosimilar approval.
The main technical risk is product equivalence and manufacturing quality. Amphotericin B products can differ materially in formulation, aggregation behavior, infusion performance, and tissue distribution. Liposomal amphotericin B is not interchangeable with conventional amphotericin B merely because both contain amphotericin B as the active antifungal.
What is the financial trajectory for Fungizone?
Fungizone does not have a separately disclosed public revenue stream that supports a precise product-level financial forecast. The historical branded franchise has transitioned into a mature generic market. Financial exposure is therefore best analyzed through market structure rather than reported brand sales.
Historical trajectory
The product’s financial trajectory has followed four stages:
- Innovator phase: High clinical value and branded pricing after launch.
- Generic erosion: Loss of exclusivity and entry by competing conventional amphotericin B suppliers.
- Formulation substitution: Migration of higher-value use toward liposomal amphotericin B and other lipid products.
- Mature generic phase: Low-margin hospital sales, tender pricing, and volume tied to severe infection incidence and supply availability.
Revenue outlook
The likely revenue profile is:
| Financial metric | Outlook |
|---|---|
| Branded Fungizone revenue | Minimal or absent as a standalone disclosed franchise |
| Generic amphotericin B volume | Stable but niche |
| Average selling price | Low, with volatility during shortages |
| Gross margin | Constrained by hospital tenders and manufacturing costs |
| Growth driver | Disease incidence, emerging fungal outbreaks, and access in developing markets |
| Downside driver | Substitution by liposomal formulations, azoles, and echinocandins |
| Price power | Weak under normal supply conditions |
| Strategic value | Supply reliability and portfolio access rather than patent rents |
A supplier with an approved conventional amphotericin B product can obtain strategic value from dependable supply, but the product is unlikely to generate the economics associated with a protected specialty drug. The strongest opportunity is often portfolio-based: pairing amphotericin B with other hospital injectables, antifungals, or anti-infective products.
What generic launch scenarios exist for Fungizone?
Generic entry is already the base case. Future competitive scenarios are more likely to concern supplier additions or withdrawals than first generic entry.
Scenario 1: Stable generic supply
Multiple manufacturers remain active. Prices stay low, and hospitals use conventional amphotericin B selectively.
Scenario 2: Supplier contraction
One or more manufacturers exit because of low margins or quality problems. Supply tightens, tender prices rise, and hospitals shift temporarily to lipid formulations or alternative antifungals.
Scenario 3: Increased use in resource-constrained markets
Demand grows in countries where liposomal amphotericin B is less accessible. Volume increases without creating strong pricing power because public procurement remains price-sensitive.
Scenario 4: Continued clinical substitution
Guideline preferences, improved access to liposomal products, and wider use of echinocandins and triazoles reduce conventional amphotericin B use in wealthier health systems.
Which companies compete with Fungizone?
Competition occurs at both the conventional amphotericin B and broader systemic-antifungal levels.
Direct competitors
Direct competitors include manufacturers of generic amphotericin B deoxycholate injection. Supplier participation varies by jurisdiction and over time, particularly in the United States, Europe, India, Latin America, and public-health procurement markets.
Formulation competitors
Key branded or differentiated competitors include:
- Gilead Sciences’ AmBisome, liposomal amphotericin B
- Leadiant and other historical suppliers of lipid-based amphotericin products, depending on market
- Manufacturers of amphotericin B lipid complex products
Therapeutic competitors
Fungizone also competes with:
- Echinocandins such as micafungin, anidulafungin, and caspofungin
- Triazoles such as voriconazole, posaconazole, isavuconazole, and fluconazole
- Other systemic antifungal therapies selected according to pathogen, resistance profile, organ function, and infection site
The competitive decision is clinical rather than purely price-based. Toxicity, resistance, route of administration, pathogen identification, and severity of disease determine product selection.
What geographic markets are most relevant to Fungizone?
The commercial value of conventional amphotericin B is geographically uneven.
United States and Western Europe
Use is concentrated in selected severe infections and situations where lipid formulations are unsuitable, unavailable, or cost-prohibitive. Liposomal amphotericin B and newer antifungals have greater influence on treatment decisions.
Emerging markets
Conventional amphotericin B remains more relevant because procurement budgets are limited and hospital access to liposomal products can be inconsistent. Public-health programs and infectious-disease centers can generate stable demand.
Low-resource settings
The product’s low acquisition cost can support continued use, but administration requires intravenous infrastructure, renal monitoring, electrolyte management, and trained personnel. These practical requirements limit access despite the drug’s age and low price.
Key Takeaways
- Fungizone is conventional amphotericin B deoxycholate, an old intravenous antifungal with no meaningful current patent exclusivity.
- The product has no relevant biosimilar risk; competition occurs through generic drug approvals.
- Paragraph IV litigation is not a material current threat or source of commercial protection.
- Liposomal amphotericin B is the main differentiated competitor because it offers a more favorable toxicity profile.
- Fungizone remains valuable in cost-sensitive hospitals, public-health programs, and markets with limited access to lipid formulations.
- Product-level revenue is not publicly disclosed in a way that supports a precise standalone forecast.
- Financial performance is likely low-margin and volume-driven, with temporary pricing power during supply disruptions.
- The main barriers are sterile manufacturing, quality control, supply reliability, and hospital procurement access, not patents.
- Long-term use in wealthy markets is likely to remain under pressure from lipid formulations, echinocandins, and triazole antifungals.
Frequently Asked Questions
Is Fungizone still sold in the United States?
Conventional amphotericin B remains available through generic injectable products, although the historical Fungizone brand is not the main commercial vehicle in the U.S. market.
Is Fungizone the same as AmBisome?
No. Fungizone is amphotericin B deoxycholate. AmBisome is liposomal amphotericin B. They have different formulations, pharmacokinetics, toxicity profiles, approvals, and substitution rules.
Can a generic manufacturer launch Fungizone without a patent license?
For conventional amphotericin B deoxycholate, expired compound and formulation rights generally do not require a license. A manufacturer must still satisfy FDA approval, sterile manufacturing, labeling, and quality requirements.
Why is Fungizone cheaper than liposomal amphotericin B?
Conventional amphotericin B is an older, generic formulation with a simpler commercial structure. Liposomal amphotericin B requires more complex lipid manufacturing, tighter product controls, and historically had stronger formulation differentiation.
Is Fungizone commercially attractive for pharmaceutical companies?
It is usually a portfolio product rather than a high-growth asset. Its appeal depends on manufacturing efficiency, reliable sterile capacity, hospital contracts, public-sector procurement, and the ability to manage shortage-related demand.
References
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U.S. Food and Drug Administration. (2023). Amphotericin B for injection prescribing information. FDA/DailyMed labeling database.
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U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. Orange Book.
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Patterson, T. F., Thompson, G. R., Denning, D. W., Fishman, J. A., Hadley, S., Herbrecht, R., et al. (2016). Practice guidelines for the diagnosis and management of aspergillosis: 2016 update by the Infectious Diseases Society of America. Clinical Infectious Diseases, 63(4), e1-e60.
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World Health Organization. (2022). Guidelines for diagnosing, preventing and managing cryptococcal disease among adults, adolescents and children living with HIV. World Health Organization.
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