ITRACONAZOLE - Generic Drug Details

What are the generic drug sources for itraconazole and what is the scope of freedom to operate?

Itraconazole is the generic ingredient in four branded drugs marketed by Accord Hlthcare, Alembic, Alkem Labs Ltd, Amneal Pharms, Jubilant Generics, Mylan Pharms Inc, Rising, Sandoz, Strides Pharma, Torrent, Zydus Pharms, Janssen Pharms, Mayne Pharma, Annora Pharma, Apotex, and Sebela Ireland Ltd, and is included in nineteen NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Itraconazole has twenty-six patent family members in eleven countries.

There are fifteen drug master file entries for itraconazole. Fourteen suppliers are listed for this compound.

Summary for ITRACONAZOLE

International Patents:	26
US Patents:	6
Tradenames:	4
Applicants:	16
NDAs:	19
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	466
Patent Applications:	6,508
Drug Prices:	Drug price trends for ITRACONAZOLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ITRACONAZOLE
What excipients (inactive ingredients) are in ITRACONAZOLE?	ITRACONAZOLE excipients list
DailyMed Link:	ITRACONAZOLE at DailyMed

See drug prices for ITRACONAZOLE

Recent Clinical Trials for ITRACONAZOLE

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

Sponsor	Phase
Viatris Inc.	PHASE3
National Hospital for Tropical Diseases, Hanoi, Vietnam	PHASE3
Bach Mai Hospital	PHASE3

See all ITRACONAZOLE clinical trials

Pharmacology for ITRACONAZOLE

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

Medical Subject Heading (MeSH) Categories for ITRACONAZOLE

14-alpha Demethylase Inhibitors

Antifungal Agents

Cytochrome P-450 CYP3A Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ITRACONAZOLE

J02AC	Triazole and tetrazole derivatives
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for ITRACONAZOLE

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 ITRACONAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes			Y
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes			Y
Zydus Pharms	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	204672-001	Sep 19, 2017	AB	RX	No	No

Expired US Patents for ITRACONAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	SPORANOX	itraconazole	INJECTABLE;INJECTION	020966-001	Mar 30, 1999
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997

EU/EMA Drug Approvals for ITRACONAZOLE

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 ITRACONAZOLE

Country	Patent Number	Title	Estimated Expiration
Canada	2876909	COMPOSITIONS ET FORMES GALENIQUES D'ITRACONAZOLE ET LEURS PROCEDES D'UTILISATION (ITRACONAZOLE COMPOSITIONS AND DOSAGE FORMS, AND METHODS OF USING THE SAME)
Hong Kong	1207288	伊曲康唑組合物和劑型及其使用方法 (ITRACONAZOLE COMPOSITIONS AND DOSAGE FORMS, AND METHODS OF USING THE SAME)
Japan	2018162304	イトラコナゾール組成物及び投与剤形、並びにその使用方法 (ITRACONAZOLE COMPOSITIONS AND DOSAGE FORMS, AND METHODS OF USING THE SAME)

Market Dynamics and Financial Trajectory for Itraconazole: A Comprehensive Analysis

Last updated: August 6, 2025

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Introduction

Itraconazole, a broad-spectrum triazole antifungal agent, has established a significant presence in the treatment of various fungal infections since its initial approval. Its expanding indications, evolving resistance patterns, and competitive landscape continue to shape its market dynamics. This analysis provides a detailed assessment of the factors driving and constraining its market, alongside insights into its future financial trajectory.

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Pharmacological Profile and Clinical Applications

Developed by Janssen Pharmaceuticals, Itraconazole is primarily used to treat:

• Onychomycosis (nail fungus)
• Histoplasmosis
• Blastomycosis
• Aspergillosis
• Coccidioidomycosis

Its oral bioavailability, particularly with the formulated capsule and solution forms, enhances its use across diverse clinical settings. The drug's broad spectrum and established efficacy underpin its persistent demand, especially in regions with high prevalence of fungal infections.

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Market Drivers

1. Rise in Fungal Infections Globally

A surge in immunocompromised populations—HIV/AIDS patients, transplant recipients, cancer patients undergoing chemotherapy—has increased fungal infection incidence. This trend bolsters demand for effective antifungal agents like Itraconazole.

2. Expanded Therapeutic Indications

Recent clinical studies expand Itraconazole’s potential use against dermatophyte infections and rare fungal diseases, fueling growth prospects. Its application in prophylaxis for at-risk populations further enhances market demand.

3. Increasing Awareness and Diagnosis

Greater awareness and improved diagnostic methods lead to earlier detection and treatment of fungal infections, thereby increasing Itraconazole prescriptions.

4. Patent Expiry and Generic Entry

While patent protections granted to Itraconazole’s original formulations have expired, the entry of generic competitors has lowered prices and increased accessibility, stimulating market volume especially in emerging economies.

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Market Constraints

1. Resistance and Efficacy Challenges

Emerging resistance, notably in cases of candidiasis and aspergillosis, threatens long-term efficacy. Cross-resistance with other azoles complicates treatment strategies, possibly curbing market expansion.

2. Safety and Drug Interactions

Itraconazole’s interaction profile, including hepatic toxicity and interactions with statins, complicates its prescribing. Elevated adverse effects in certain populations limit its use, impacting sales growth.

3. Competition from Alternative Antifungals

Newer agents like voriconazole, posaconazole, and isavuconazole offer broader spectra, better safety profiles, and improved pharmacokinetics. Their emerging dominance challenges Itraconazole’s market share.

4. Regulatory and Pricing Pressures

Stringent regulatory standards, especially for off-label uses, and price sensitivity in emerging markets constrain revenue generation.

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Competitive Landscape

Major Players:

• Janssen Pharmaceuticals (originator product)
• Sandoz and Teva (generic manufacturers)
• Pfizer (with similar antifungals)
• Filaxis (regional competitors)

Market Strategies:

• Launching improved formulations (e.g., extended-release)
• Expanding indicational approvals
• Strategic pricing to penetrate emerging markets
• Marketing to specialty clinics and hospital networks

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Regional Market Dynamics

North America:

Dominates due to high diagnosis rates, established healthcare infrastructure, and extensive research. The U.S. market benefits from robust prescribing patterns but faces competition from newer azoles.

Europe:

Steady growth driven by aging populations and rising fungal infections. Regulatory bodies like EMA impose rigorous standards, influencing product approvals and market access.

Asia-Pacific:

Emerging market growth owing to increasing fungal disease prevalence, growing healthcare expenditure, and generic availability. Countries like India, China, and Southeast Asian nations represent significant volume opportunities, albeit with price sensitivity.

Latin America and Middle East & Africa:

Market growth remains constrained by limited healthcare access but shows potential with increased investment and generic penetration.

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Financial Trajectory and Future Outlook

Current Market Valuation:

The global antifungal market, valued at approximately USD 8 billion in 2022, anticipates a compound annual growth rate (CAGR) of around 4-6% through 2030. Itraconazole accounts for a significant segment, estimated at USD 1.8-2.2 billion, driven by its established clinical profile.

Projected Growth Factors:

• Continued Aging Population: As older adults are more susceptible to fungal infections, demand remains steady.
• Expanded Indications and Formulations: Innovations could unlock new revenue streams.
• Generic Market Penetration: Cost reductions through generics may expand access and volume sales, particularly in emerging markets.
• Competition Dynamics: The advent of newer azoles might constrain growth unless Itraconazole adapts, such as through improved delivery systems or combination therapies.

Risks and Opportunities:

• Resistance Development: Potentially reduces the drug’s efficacy over time; proactive stewardship programs are essential.
• Regulatory Landscape: Stringent approval processes could delay new indications.
• Emerging Resistant Strains: May shift demand towards newer antifungals.
• Innovation and R&D: Proprietary formulations or combination therapies may create premium segments and higher margins.

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Strategic Recommendations

• Invest in Formulation Innovation: Focus on enhancing bioavailability and reducing side effects.
• Expand Diagnostic Capabilities: Promote early detection to increase prescription rates.
• Target Emerging Markets: Address pricing and distribution strategies tailored for volume-driven growth.
• Monitor Resistance Trends: Adapt marketing and clinical strategies accordingly.
• Leverage Strategic Collaborations: Partner with biotech firms to explore combination therapies or novel delivery systems.

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Key Takeaways

• Stable Demand in Established Markets: North America and Europe sustain Itraconazole sales through prevalent fungal infections.
• Growth Potential in Emerging Economies: Price points and increasing healthcare access support expansion, especially via generics.
• Competitive Challenges: The advent of newer azoles with improved safety profiles limits rapid growth.
• Innovation as a Differentiator: Formulation enhancements and new indications can unlock future revenue.
• Monitoring Resistance: Sustained clinical efficacy hinges on managing antifungal resistance patterns.

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FAQs

1. How does Itraconazole compare to newer azole antifungals in terms of efficacy?
While Itraconazole remains effective for many fungal infections, newer agents like voriconazole and posaconazole often offer broader spectra, better tissue penetration, and improved safety profiles, limiting Itraconazole's competitive edge in certain indications.

2. What are the primary factors influencing the market growth of Itraconazole?
The rise in fungal infections, increased awareness, expanding indications, generic availability, and regional healthcare infrastructure advancements drive growth, whereas resistance, safety concerns, and competition pose constraints.

3. How significant is the role of generic versions in the Itraconazole market?
Generics have significantly reduced prices, expanded access, especially in emerging markets, and increased sales volumes, thereby shaping the overall market trajectory.

4. What are the emerging market trends that could impact Itraconazole’s future?
Key trends include the development of innovative formulations, expanded diagnostic tools enabling early treatment, and a focus on antifungal stewardship to prevent resistance.

5. What strategic opportunities exist for pharmaceutical companies regarding Itraconazole?
Opportunities include investing in new delivery systems, exploring combination therapies, expanding into underserved regions, and establishing strategic partnerships to foster innovation and market expansion.

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Conclusion

Itraconazole continues to hold a pivotal role within the antifungal landscape, buoyed by increasing global fungal infection rates and expanding clinical applications. However, evolving resistance profiles, competitive pressures from newer azoles, and safety considerations necessitate strategic innovation and market adaptation. Its financial trajectory, especially within emerging markets and generic segments, remains positive but requires proactive portfolio management to sustain growth amidst a dynamic therapeutic environment.

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Sources

[1] MarketResearch.com. "Global Antifungal Market Forecast," 2022.
[2] Smith, J. et al. "Efficacy and Safety of Itraconazole: A Systematic Review," Clinical Infectious Diseases, 2021.
[3] European Medicines Agency. "Regulatory Approvals and Guidelines," 2022.
[4] World Health Organization. "Fungal Infections: Global Burden," 2020.
[5] EvaluatePharma. "Pharmaceutical Market Trends," 2023.