SPORANOX Drug Patent Profile

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

Sporanox is a drug marketed by Janssen Pharms and is included in three NDAs.

The generic ingredient in SPORANOX is itraconazole. There are fifteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sporanox

A generic version of SPORANOX was approved as itraconazole by SANDOZ on May 28^th, 2004.

Summary for SPORANOX

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	40
Patent Applications:	5,974
Drug Prices:	Drug price information for SPORANOX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SPORANOX
What excipients (inactive ingredients) are in SPORANOX?	SPORANOX excipients list
DailyMed Link:	SPORANOX at DailyMed

See drug prices for SPORANOX

Recent Clinical Trials for SPORANOX

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

Sponsor	Phase
University of Chicago	Phase 1
Arvinas Estrogen Receptor, Inc.	Phase 1
Postgraduate Institute of Medical Education and Research	N/A

See all SPORANOX clinical trials

Pharmacology for SPORANOX

Drug Class	Azole Antifungal
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Paragraph IV (Patent) Challenges for SPORANOX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SPORANOX	Oral Solution	itraconazole	10 mg/mL	020657	1	2013-05-03

US Patents and Regulatory Information for SPORANOX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	SPORANOX	itraconazole	CAPSULE;ORAL	020083-001	Sep 11, 1992	AB	RX	Yes	Yes
Janssen Pharms	SPORANOX	itraconazole	INJECTABLE;INJECTION	020966-001	Mar 30, 1999		DISCN	No	No
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997		DISCN	Yes	No

Expired US Patents for SPORANOX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997	4,791,111
Janssen Pharms	SPORANOX	itraconazole	INJECTABLE;INJECTION	020966-001	Mar 30, 1999	4,727,064
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997	4,727,064
Janssen Pharms	SPORANOX	itraconazole	CAPSULE;ORAL	020083-001	Sep 11, 1992	4,267,179
Janssen Pharms	SPORANOX	itraconazole	INJECTABLE;INJECTION	020966-001	Mar 30, 1999	6,407,079

EU/EMA Drug Approvals for SPORANOX

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Avimedical B.V.	Fungitraxx	itraconazole	EMEA/V/C/002722For the treatment of aspergillosis and candidiasis in companion birds,	Authorised	no	no	no	2014-03-12

International Patents for SPORANOX

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1006000
China	1086579
Singapore	48826	Oral formulations of an antifungal
Canada	1149386	DERIVES HETEROCYCLIQUES DE (4-PHENYL- PIPERAZIN-1-YLARYLOXYMETHYL-1,3-DIOXOLAN-2-YL) METHYL-1H-IMIDAZOLES ET 1H-1,2,4-TRIAZOLES (HETEROCYCLIC DERIVATIVES OF (4-PHENYL- PIPERAZIN-1-YLARYLOXYMETHYL-1,3-DIOXOLAN- 2-YL)METHYL-1H-IMIDAZOLES AND 1H-1,2,4-TRIAZOLES)
New Zealand	218553	((4-(4-(4-PHENYL-1-PIPERAZINYL)-PHENOXY METHYL)-1,3-DIOXOLAN-2-YL)-METHYL)-1H-IMIDAZOLE AND -1H-1,2,4 TRIAZOLE DERIVATIVES AS PHARMACEUTICALS

Supplementary Protection Certificates for SPORANOX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0006711	SPC/GB93/038: EXPIRE	United Kingdom

Market Dynamics and Financial Trajectory for SPORANOX (Itraconazole)

Last updated: July 31, 2025

Introduction

SPORANOX (itraconazole) has maintained a pivotal role in the antifungal therapeutic landscape since its approval. As a broad-spectrum triazole antifungal agent, SPORANOX's efficacy across systemic mycoses—including histoplasmosis, aspergillosis, and onychomycosis—has cemented its significance among healthcare providers. Understanding its market dynamics and financial trajectory involves examining the evolving disease landscape, competitive environment, regulatory landscape, and the pharmaceutical industry's strategic maneuvers.

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Market Overview

Therapeutic Area and Clinical Demand

SPORANOX chiefly addresses invasive fungal infections and dermatophyte conditions. The increasing prevalence of immunocompromised populations—particularly HIV/AIDS, organ transplant, and oncology patients—fuels demand for effective antifungal treatments [1].

The global antifungal market is projected to reach approximately USD 15 billion by 2026, growing at a CAGR of 4-6% (2021–2026), driven by rising fungal infection incidences and better diagnostic tools [2]. Within this space, itraconazole retains a substantial market share, especially in oral formulations due to its versatility and proven efficacy.

Geographic Market Distribution

The Asia-Pacific region, especially India and China, represents burgeoning markets due to high fungal infection incidences and increasing healthcare access. North America and Europe, with established healthcare infrastructure, contribute stable revenues, with growth driven by demographic shifts and expanding indications.

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Competitive Landscape

Key Competitors

SPORANOX faces competition from several antifungal agents:

• Fluconazole (Diflucan): Cost-effective alternative for candidiasis but less broad-spectrum.
• Voriconazole (Vfend): Preferred for invasive aspergillosis with superior CNS penetration.
• Posaconazole and Isavuconazole: Newer triazoles offering enhanced safety profiles.

While these agents compete on efficacy, safety, and cost, itraconazole’s broad-spectrum activity sustains its clinical niche. Still, patent expirations of comparable drugs and generic proliferation could threaten SPORANOX’s market dominance.

Genericization and Market Penetration

Generic versions of itraconazole entered several markets post-patent expiry, reducing drug prices and expanding patient access. However, pricing pressures risk compressing profit margins, prompting companies to diversify portfolios or invest in new formulations.

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Regulatory and Patent Landscape

Regulatory Status

SPORANOX received FDA approval in 1992 and CE marking in the European Union, with ongoing post-marketing commitments. Recent approvals seek expanded indications, such as prophylactic uses in hematology.

Patent and Exclusivity

The original patents have expired in major markets, with generic manufacturers challenging the brand’s exclusivity. The resultant price erosion impacts revenue streams—particularly in price-sensitive markets.

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Financial Trajectory & Revenue Streams

Historical Performance

Initially, SPORANOX experienced steady sales driven by its wide-spectrum antifungal activity. Over time, patent expiration-related generic competition attenuated growth. In 2021, Pfizer reported global sales of SPORANOX exceeding USD 110 million, with a notable decline from prior peaks amid generic entry [3].

Revenue Drivers

Key factors influencing revenues include:

• Market Penetration: Expansion into emerging markets with limited antifungal options.
• Regulatory Approvals: New indications can open additional revenue channels.
• Pricing Strategies: Tiered pricing and bundling to sustain margins amid generic competition.
• Manufacturing Costs: Optimization through scale and process innovation.

Forecasted Financial Trajectory

Given patent expiry and increasing competition, revenues are expected to decline moderately in mature markets but could stabilize or grow marginally in emerging regions. Strategic investments, like combination therapies or novel formulations, could provide new revenue streams.

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Market Challenges and Opportunities

Challenges

• Price Competition: Widespread generics diminish profit margins.
• Regulatory Hurdles: Approvals for new indications are lengthy and costly.
• Emerging Resistance: Fungal resistance to azole class could reduce efficacy.
• Market Saturation: In developed markets, growth potential is limited.

Opportunities

• Biomarker and Diagnostic Advances: Enable targeted therapy, bolstering efficacy and adoption.
• Development of Novel Formulations: Extended-release, inhalable, or IV options could expand usage.
• Strategic Partnerships: Collaborations with biotech firms can facilitate pipeline diversification.
• Growing Global Disease Burden: Rising fungal infections, especially in immunocompromised populations, ensure sustained demand.

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Impact of External Factors

• Healthcare Policy & Reimbursement: Variations influence access and sales, with reimbursement growth favoring branded formulations in certain regions.
• Pandemic Effects: COVID-19 heightened awareness of fungal infections, possibly increasing antifungal use.
• Supply Chain Dynamics: Raw material costs and manufacturing complexities impact profitability.

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Conclusion

SPORANOX’s market dynamics are now characterized by the interplay of patent expiries, generic competition, and emerging therapeutic needs. While facing pressure from low-cost generics, it retains niche dominance through clinical efficacy and expanding indications. The company's strategy focusing on innovation, targeted marketing, and geographic expansion will be critical for sustaining its financial trajectory in a rapidly evolving antifungal market landscape.

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Key Takeaways

• The antifungal market's growth is driven by increasing immunocompromised populations, especially in emerging markets.
• Patent expiries and generic entry significantly impact SPORANOX’s revenue streams, necessitating strategic diversification.
• Competitive positioning depends on innovation in formulations and expanding indications.
• Regulatory environments and reimbursement policies significantly influence market penetration.
• Future growth hinges on technological advancements, geographic expansion, and addressing antifungal resistance issues.

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FAQs

1. How does patent expiration affect SPORANOX's market performance?
Patent expiration leads to generic competition, typically resulting in significant price reductions and revenue decline for the original brand. Companies often respond with new formulations or expanded uses to maintain market share.

2. Are there any recent developments in SPORANOX’s formulation or indications?
Pfizer and other manufacturers are exploring new formulations such as inhalable itraconazole and expanding indications like prophylaxis in immunocompromised patients, which could influence future sales.

3. What is the outlook for SPORANOX in emerging markets?
Growing healthcare infrastructure, increasing fungal infections, and lower generic penetration position emerging markets as promising growth areas for SPORANOX.

4. How does antifungal resistance impact SPORANOX's long-term prospects?
Resistance to azoles like itraconazole could limit their effectiveness, emphasizing the need for developing novel agents and combination therapies to sustain efficacy.

5. What strategic moves can Pfizer leverage to maintain SPORANOX’s relevance?
Investments in new formulations, expanding indications, strategic partnerships, and entering emerging markets are pivotal for sustaining market relevance amid competitive pressures.

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References

[1] International Journal of Infectious Diseases, 2020. Trends in fungal infections among immunocompromised populations.
[2] MarketWatch, 2022. Global antifungal market forecast 2021-2026.
[3] Pfizer Annual Report 2021. Financial disclosures and sales data for SPORANOX.