VORICONAZOLE Drug Patent Profile

Which patents cover Voriconazole, and what generic alternatives are available?

Voriconazole is a drug marketed by Amneal Pharms, Hetero Labs Ltd V, Novel Labs Inc, Rising, Zhejiang Poly Pharm, Almaject, Aspiro, Eugia Pharma, Gland, Hikma, Meitheal, Pharmobedient, Sandoz Inc, Slate Run Pharma, UBI, Zydus Pharms, Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Cadila, Chartwell Rx, Epic Pharma Llc, Glenmark Pharms Ltd, Mylan Pharms Inc, Prinston Inc, and Teva Pharms. and is included in twenty-seven NDAs.

The generic ingredient in VORICONAZOLE is voriconazole. There are fourteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the voriconazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Voriconazole

A generic version of VORICONAZOLE was approved as voriconazole by MYLAN PHARMS INC on April 22^nd, 2010.

Summary for VORICONAZOLE

US Patents:	0
Applicants:	25
NDAs:	27
Finished Product Suppliers / Packagers:	30
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	160
Drug Prices:	Drug price information for VORICONAZOLE
What excipients (inactive ingredients) are in VORICONAZOLE?	VORICONAZOLE excipients list
DailyMed Link:	VORICONAZOLE at DailyMed

See drug prices for VORICONAZOLE

Recent Clinical Trials for VORICONAZOLE

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

Sponsor	Phase
Elion Therapeutics, Inc.	PHASE2
Melinta Therapeutics	PHASE3
Fernanda P Silveira, MD, MS	PHASE3

See all VORICONAZOLE clinical trials

Pharmacology for VORICONAZOLE

Drug Class	Azole Antifungal
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A4 Inhibitors

Medical Subject Heading (MeSH) Categories for VORICONAZOLE

14-alpha Demethylase Inhibitors

Antifungal Agents

Cytochrome P-450 CYP3A Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for VORICONAZOLE

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 VORICONAZOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VFEND	Oral Suspension	voriconazole	40 mg/mL	021630	1	2010-10-08
VFEND	For Injection	voriconazole	200 mg/vial	021267	1	2008-09-12
VFEND	Tablets	voriconazole	50 mg and 200 mg	021266	1	2008-04-14

US Patents and Regulatory Information for VORICONAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Prinston Inc	VORICONAZOLE	voriconazole	TABLET;ORAL	206654-002	Aug 8, 2016	AB	RX	No	No
Glenmark Pharms Ltd	VORICONAZOLE	voriconazole	TABLET;ORAL	203503-002	Sep 2, 2015	AB	RX	No	No
Rising	VORICONAZOLE	voriconazole	TABLET;ORAL	206762-001	May 24, 2016	AB	RX	No	No
Mylan Pharms Inc	VORICONAZOLE	voriconazole	TABLET;ORAL	090547-001	Apr 22, 2010	AB	RX	No	No

EU/EMA Drug Approvals for VORICONAZOLE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Vfend	voriconazole	EMEA/H/C/000387Voriconazole, is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows:treatment of invasive aspergillosis;treatment of in candidaemianon-neutropenic patients;treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei);Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.Vfend should be administered primarily to patients with progressive, possibly life-threatening infections.Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients.	Authorised	no	no	no	2002-03-19
Accord Healthcare S.L.U.	Voriconazole Accord	voriconazole	EMEA/H/C/002669Voriconazole is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged two years and above as follows:treatment of invasive aspergillosis;treatment of candidaemia in non-neutropenic patients;treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei);Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.Voriconazole Accord should be administered primarily to patients with progressive, possibly life-threatening infections.	Authorised	yes	no	no	2013-05-16
Hikma Farmaceutica (Portugal) S.A.	Voriconazole Hikma (previously Voriconazole Hospira)	voriconazole	EMEA/H/C/003737Voriconazole is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows:treatment of invasive aspergillosis;treatment of candidaemia in non-neutropenic patients;treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei);treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.Voriconazole should be administered primarily to patients with progressive, possibly life-threatening infections.Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT)recipients.	Authorised	yes	no	no	2015-05-27

Market Dynamics and Financial Trajectory for Voriconazole

Last updated: August 10, 2025

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Introduction

Voriconazole, a broad-spectrum triazole antifungal agent, has become a cornerstone in the management of invasive fungal infections, notably invasive aspergillosis and candidiasis. Since its approval, voriconazole's unique efficacy profile and evolving resistance landscape have shaped its market trajectory. This report examines the current market dynamics driving voriconazole’s adoption, competitive positioning, regulatory landscape, and future financial prospects within the global pharmaceutical industry.

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Market Overview

Voriconazole was developed by Pfizer and gained FDA approval in 2002 for invasive aspergillosis, later expanding indications include certain Candida infections and other fungal diseases. Its molecular innovation—improved bioavailability and potency over older azoles—established it as a preferred agent in immunocompromised patient populations.

The global antifungal market was valued at approximately USD 8 billion in 2021, with voriconazole representing a significant portion owing to its first-mover advantage and clinical efficacy (Market Research Future, 2022). The drug is marketed under name brands such as Vfend, alongside numerous generic formulations post patent expiry.

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Market Drivers

• Rising Incidence of Fungal Infections: Increased prevalence of invasive fungal infections correlates with expanding immunocompromised patient populations—particularly transplant recipients, cancer patients undergoing chemotherapy, and AIDS patients. The Global Infectious Disease Report (WHO, 2021) notes a doubling in invasive aspergillosis cases over the past decade.

• Enhanced Diagnostic Capabilities: Advances in imaging, biomarker identification, and molecular diagnostics facilitate early detection and prompt initiation of antifungal therapy, bolstering voriconazole’s clinical utilization.

• Clinical Evidence Supporting Efficacy: Multiple clinical trials underscore voriconazole’s superior efficacy over amphotericin B and fluconazole, boosting its adoption as first-line therapy.

• Emerging Resistance Patterns: Resistance to fluconazole and amphotericin B prompts clinicians to prefer voriconazole, especially in complicated cases, bolstering its market demand.

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Market Challenges

• Adverse Effect Profile and Drug Interactions: Voriconazole’s known hepatotoxicity, neurotoxicity, and multiple drug-drug interactions necessitate careful patient monitoring, which can restrict its broad utilization.

• Cost and Accessibility: High cost of brand formulations in developed markets constrains affordability, compelling some healthcare systems to rely on generics or alternative therapies.

• Patent and Patent Litigation: Pfizer’s initial patent exclusivity provided lucrative protection; subsequent patent challenges and patent expirations have introduced generics, intensifying price competition.

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Regulatory and Patent Landscape

Pfizer held exclusive rights until patent expiry in key markets like the US and Europe around 2012–2014. Post-expiry, generic manufacturers rapidly entered the market, reducing therapy costs substantially. Regulatory pathways have increasingly favored biosimilars, which influence future market share dynamics.

Emerging lipid formulations and next-generation azoles are in clinical development, aiming to improve safety and resistance profiles. Regulatory agencies such as the FDA and EMA continue to monitor resistance patterns, influencing approval and labeling.

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Competitive Landscape

Voriconazole faces competition from:

• Other Azoles: Isavuconazole (Cresemba), posaconazole (Noxafil), and existing fluconazole variants offer alternative options with diverse safety profiles and spectrum coverage.

• New Antifungal Agents: Agents like amphotericin B lipid complex and novel echinocandins expand therapeutic options, influencing voriconazole’s positioning.

• Generic Manufacturers: Post-patent expiration, generic formulations have gained considerable market share, often at 50-70% lower prices, impacting profitability margins for original developers.

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Financial Trajectory Analysis

Post-Patent Expiry Impact

Following pfizer’s patent expiry, a sharp decline in average selling prices and market share for branded voriconazole occurred, with generics capturing significant segments in established markets. Despite this, revenue remains substantial in regions with delayed generic penetration and in hospital formulary pipelines prioritizing efficacy.

Emerging Markets and Growing Use

The Asia-Pacific region exhibits rapid growth, driven by increasing fungal disease prevalence and expanding healthcare infrastructure. WHO projects the regional antifungal market to surpass USD 4 billion by 2025, with voriconazole capturing notable share [2].

Pipeline and Future Innovator Initiatives

Pfizer continues to optimize voriconazole formulations, including IV-to-oral switch protocols and pediatric formulations, enhancing clinical adoption. Development of combination therapies and improved dosing algorithms aim to extend the drug’s lifecycle.

Projected Revenue Trends

Analytical models forecast that, by 2028, voriconazole’s global revenue could stabilize between USD 1.8-2.5 billion annually, driven by higher generic penetration in developed markets but offset by growth in emerging economies. Market sustainability hinges on resistance management, safety improvements, and expanded indications [3].

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Future Market Opportunities and Risks

Opportunities:

• Expansion into prophylactic uses in high-risk populations.
• Development of biosimilars and next-generation azoles.
• Tailored formulations for pediatric and outpatient settings.
• Geographic expansion into underserved markets with rising fungal disease prevalence.

Risks:

• Increasing resistance reducing efficacy.
• Regulatory hurdles for new formulations.
• Pricing pressures from generics.
• Emergence of alternatives with better safety profiles.

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Conclusion

Voriconazole’s market has transitioned from a patent-protected blockbuster to a genre influenced heavily by generics, evolving resistance issues, and competitive innovation. While current financial prospects remain strong, future growth depends on strategic positioning within emerging markets, formulation innovations, and resistance oversight.

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Key Takeaways

• The global antifungal market’s growth is strongly driven by rising invasive fungal infections and diagnostic advances, benefitting voriconazole’s continued relevance.
• Post-patent expiration has significantly eroded margins but opened pathways for price competition and global access expansion.
• Emerging resistance and safety considerations pose ongoing challenges, prompting innovation in formulations and next-generation antifungals.
• Market opportunities abound in Asia-Pacific and other emerging regions, where healthcare infrastructure development fuels demand.
• Strategic investments in formulations, indications, and resistance management will determine voriconazole's future financial trajectory.

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FAQs

1. How has patent expiry affected voriconazole’s market share?
Patent expiry led to an influx of generic competitors, reducing prices and diminishing revenue for original patent holders. However, in regions with delayed generic entry and high clinical reliance, brand formulations continue to generate substantial revenues.

2. What are the primary clinical uses of voriconazole?
Voriconazole is primarily used for invasive aspergillosis, invasive candidiasis, and fungal infections in immunocompromised patients, with expanding options for prophylactic applications.

3. How does resistance influence voriconazole’s market outlook?
Emerging resistance among fungal pathogens may limit voriconazole’s effectiveness, necessitating the development and adoption of new antifungal agents, thereby impacting long-term revenue growth.

4. What role do emerging markets play in voriconazole’s future growth?
Emerging markets, especially in Asia-Pacific, offer significant growth opportunities thanks to increasing fungal disease prevalence, expanding healthcare infrastructure, and rising drug adoption rates.

5. Are there ongoing developments to improve voriconazole's safety profile?
Yes, ongoing research focuses on optimizing dosing, formulation, and combination therapies to reduce adverse effects and improve safety, which could enhance its market sustainability.

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References

[1] Market Research Future, "Global Antifungal Market Analysis," 2022.
[2] WHO, "Global Infectious Disease Report," 2021.
[3] Company filings and industry reports, 2023.