VFEND Drug Patent Profile

When do Vfend patents expire, and when can generic versions of Vfend launch?

Vfend is a drug marketed by Pf Prism Cv and is included in three NDAs.

The generic ingredient in VFEND 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 Vfend

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

Summary for VFEND

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	96
Patent Applications:	6,110
Drug Prices:	Drug price information for VFEND
What excipients (inactive ingredients) are in VFEND?	VFEND excipients list
DailyMed Link:	VFEND at DailyMed

See drug prices for VFEND

Pharmacology for VFEND

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

Paragraph IV (Patent) Challenges for VFEND

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 VFEND

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pf Prism Cv	VFEND	voriconazole	FOR SUSPENSION;ORAL	021630-001	Dec 19, 2003	AB	RX	Yes	Yes
Pf Prism Cv	VFEND	voriconazole	TABLET;ORAL	021266-002	May 24, 2002	AB	RX	Yes	Yes
Pf Prism Cv	VFEND	voriconazole	POWDER;INTRAVENOUS	021267-001	May 24, 2002	AP	RX	Yes	Yes
Pf Prism Cv	VFEND	voriconazole	TABLET;ORAL	021266-001	May 24, 2002	AB	RX	Yes	No

Expired US Patents for VFEND

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	VFEND	voriconazole	TABLET;ORAL	021266-002	May 24, 2002
Pf Prism Cv	VFEND	voriconazole	TABLET;ORAL	021266-002	May 24, 2002
Pf Prism Cv	VFEND	voriconazole	POWDER;INTRAVENOUS	021267-001	May 24, 2002
Pf Prism Cv	VFEND	voriconazole	TABLET;ORAL	021266-001	May 24, 2002
Pf Prism Cv	VFEND	voriconazole	TABLET;ORAL	021266-001	May 24, 2002
Pf Prism Cv	VFEND	voriconazole	FOR SUSPENSION;ORAL	021630-001	Dec 19, 2003

EU/EMA Drug Approvals for VFEND

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

International Patents for VFEND

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

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	199900937
Tajikistan	275	Derivatives of cyclodextrins exhibiting enhenced aqueous solubility and the use thereof
Hungary	228338	PHARMACEUTICAL FORMULATIONS CONTAINING VORICONAZOLE
Australia	625188
Saudi Arabia	521	مستحضرات دوائية مشتملة على فوريكونازول VORICONAZOLE
China	1026788

Supplementary Protection Certificates for VFEND

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0440372	90960	Luxembourg
0440372	02C0030	France		PRODUCT NAME: VORICONAZOLE; NAT. REGISTRATION NO/DATE: EU/1/02/212/001-025 20020319; FIRST REGISTRATION: EU/1/02/212/001-25 20020319
0440372	SPC/GB02/031	United Kingdom		PRODUCT NAME: VORICONAZOLE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/02/212/001-025 20020319
0440372	C300100	Netherlands		PRODUCT NAME: VORICONAZOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/02/212/001-025 20020319
1001813	PA2003005	Lithuania		PRODUCT NAME: VORICONAZOLIS; REGISTRATION NO/DATE: 02/7890/8 20021002

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: VFEND (Voriconazole)

Last updated: September 10, 2025

Introduction

VFEND, the brand name for voriconazole, is a triazole antifungal medication developed by Pfizer. Approved by the U.S. Food and Drug Administration (FDA) in 2002, VFEND has become a critical agent in the treatment of invasive fungal infections, including aspergillosis and candidemia, especially in immunocompromised populations. Its market trajectory is shaped by factors such as increasing fungal infection prevalence, evolving treatment paradigms, generic entry, and developments in diagnostic technologies. This report provides an in-depth analysis of VFEND’s market dynamics and financial outlook, emphasizing key drivers, competitive landscape, regulatory factors, and forecasting trends.

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Market Landscape and Key Drivers

Growing Incidence of Invasive Fungal Infections

The rising prevalence of invasive fungal infections (IFIs)—particularly among immunocompromised patients, such as those undergoing hematopoietic stem cell transplantation, chemotherapy, or intensive care—has bolstered demand for effective antifungal agents like voriconazole. The global immunosuppressive therapy expansion, coupled with increased awareness and diagnostic capabilities, has further expanded the patient pool eligible for VFEND.

Advancements in Treatment Guidelines

Guidelines from organizations such as the Infectious Diseases Society of America (IDSA) increasingly recommend voriconazole as first-line therapy for invasive aspergillosis. This authoritative endorsement consolidates VFEND’s position in clinical practice, fostering steady demand through prescription volume growth.

Global Expansion and Regional Growth

While North America and Europe represent mature markets with high penetration, emerging economies in Asia-Pacific and Latin America show significant growth potential. Rising healthcare infrastructure, increased healthcare spending, and expanding awareness underpin regional demand expansion.

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Competitive and Market Environment

Patent Expiry and Generic Competition

Pfizer’s patent protection for VFEND in key markets is set to expire or has expired in certain regions, opening avenues for generic formulations. The entrance of generics in 2023 has intensified price competition, exerting downward pressure on revenues. However, Pfizer's strategic launch of authorized generics and differentiated formulations helps mitigate erosion.

Emergence of New Antifungal Agents

Innovative antifungal therapies, such as isavuconazole (Cresemba), amphotericin derivatives, and combination regimens, introduce competitive dynamics. Their positioning based on efficacy, safety profiles, and dosing convenience influence VFEND’s market share.

Diagnostics and Personalized Medicine

Advances in molecular diagnostics enable earlier detection of IFIs, facilitating timely intervention. Personalized treatment approaches may influence prescribing patterns, potentially favoring formulations with proven pharmacokinetics and safety profiles like VFEND.

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Regulatory Landscape and Clinical Developments

Regulatory Approvals and Labeling

Regulatory bodies continue to approve novel formulations, combinations, and broadening of indications for voriconazole. Recent approvals of IV-to-Oral transition formulations increase treatment flexibility and adherence.

Post-Marketing Surveillance и New Clinical Evidence

Ongoing clinical trials and real-world evidence bolster the safety and efficacy profiles of VFEND. These data influence formulary decisions and treatment guidelines, sustaining market relevance.

Orphan and Special Disease Designations

Certain regions provide incentives for antifungals targeting rare or difficult-to-treat fungal infections, further impacting VFEND’s regulatory and reimbursement pathways.

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Financial Trajectory and Revenue Forecasts

Historical Revenue Performance

Pfizer reported that voriconazole sales contributed substantially to its infectious disease portfolio, with peak revenues reaching over $700 million globally in the late 2010s. The introduction of generics in 2023 led to a notable decline in sales volume and revenue, reflecting the typical patent cliff scenario.

Impact of Generic Entry

Post-patent expiration, Pfizer’s revenues are projected to decline by approximately 50-70% over the next 3-5 years, aligning with patterns observed in other branded drugs post-generic entry. Price erosion, market share redistribution, and discounting further accelerate this decline.

Future Revenue Streams

Despite near-term revenue dips, Pfizer’s strategic focus on expanding formulations (e.g., IV, oral, pediatric), exploring new indications, and integrating diagnostic innovations can generate future revenue streams. Additionally, efforts to secure new patent protections via formulation patents or expanded indications could extend the drug's lifecycle.

Market Growth in Emerging Economies

In emerging markets, where generics are dominant, voriconazole’s volume sales are expected to show moderate growth, supported by increasing healthcare access and rising awareness. However, profit margins may be lower compared to premium markets due to pricing pressures.

Cost Dynamics and Investment

Pfizer’s R&D investments in antifungal therapy optimization and companion diagnostics underpin incremental value creation. Marketing expenditures for education and regional expansion are critical components influencing profitability.

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Strategic Outlook

Innovation and Differentiation: Pfizer’s commitment to improving formulation convenience, reducing adverse effects, and expanding indications remains vital. Investment in companion diagnostics and personalized therapies can optimize utilization.

Lifecycle Management: Securing additional patents, new combination therapies, and exploring orphan indications are essential to curtail revenue erosion due to generics.

Market Diversification: Expanding penetration in emerging markets, leveraging local partnerships, and tailoring pricing strategies will support revenue stabilization.

Pricing and Reimbursement: Navigating evolving healthcare policies and reimbursement frameworks across regions impacts profitability. Demonstrating clinical value is essential, especially in cost-conscious markets.

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Key Takeaways

• Increasing Disease Burden Drives Demand: The growth of immunocompromised populations and improved diagnostics sustain steady demand for voriconazole, despite patent expirations.

• Patent Expiry and Generic Competition Are Major Risks: The arrival of generics has sharply reduced revenues in developed markets, emphasizing the need for lifecycle management.

• Emerging Markets Offer Growth Opportunities: Healthcare expansion in Asia-Pacific and Latin America supports volume growth, albeit at lower margins.

• Innovation and Differentiation Are Critical: Continued investments in formulations, indications, and companion diagnostics will be decisive in maintaining market relevance.

• Strategic Diversification Is Imperative: Diversifying product portfolio and entering new indications or formulations can offset revenue declines and extend drug lifecycle.

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FAQs

1. How has generic entry affected VFEND’s market share and revenues?
The entry of generics in 2023 has led to significant price erosion and a decline in Pfizer’s voriconazole revenues by approximately 50-70% in the subsequent years. Market share has shifted toward multiple generic manufacturers, reducing Pfizer's dominance.

2. What are the upcoming opportunities for voriconazole in the global market?
Opportunities include expanding into emerging markets, developing new formulations (e.g., pediatric), securing additional indications such as prophylaxis, and integrating diagnostic tools for personalized therapy.

3. How does clinical guideline endorsement influence VFEND’s market dynamics?
Endorsements from organizations like the IDSA position voriconazole as a first-line therapy, supporting sustained prescription volumes and market relevance amid competing agents.

4. What is the outlook for VFEND’s revenue trajectory over the next five years?
Initially, revenues are expected to decline sharply due to patent expiry, but strategic investments and market expansion could stabilize or slightly improve sales in emerging regions, ultimately resulting in a phased decline.

5. Can Pfizer extend VFEND’s lifecycle?
Yes. Patent defenses such as new formulations, novel indications, or combination therapies, along with lifecycle management strategies, are essential to prolong the drug’s commercial viability.

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References

1. FDA Drug Database. Voriconazole (VFEND) Approval. 2002.
2. Pfizer Annual Reports. (2010–2022).
3. Infectious Diseases Society of America (IDSA) Guidelines. 2016.
4. MarketResearch.com. Global Antifungal Market Outlook. 2022.
5. IQVIA Revenue Data. 2022–2023.