VFEND Drug Patent Profile

Which patents cover Vfend, 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

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

International Patents for VFEND

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

Country	Patent Number	Title	Estimated Expiration
Germany	10299035
Romania	109648	DERIVATI 1 H-1,2,4-TRIAZOL,PROCEDEE PENTRU PREPARAREA ACESTORA,INTERMEDIARI PENTRU REALIZAREA PROCEDEELOR SI METODA PENTRU TRATAREA SAU PREVENIREA INFECTIEI FUNGICE (ANTI FUNGIC AGENTS ON THE TRIAZOLE BASIS)
Poland	162953
United Kingdom	9002375
Yugoslavia	68199
Denmark	172471

Supplementary Protection Certificates for VFEND

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
1001813	PA2003005	Lithuania		PRODUCT NAME: VORICONAZOLIS; REGISTRATION NO/DATE: 02/7890/8 20021002
0440372	SPC/GB02/031	United Kingdom		PRODUCT NAME: VORICONAZOLE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/02/212/001-025 20020319
0440372	90960	Luxembourg

Investment Scenario and Fundamentals Analysis for VFEND

Last updated: February 3, 2026

What is VFEND?

VFEND (active ingredient: voriconazole) is a broad-spectrum antifungal medication developed by Pfizer. It is used primarily for invasive fungal infections such as invasive aspergillosis and serious Candida infections in immunocompromised patients. Approved in multiple markets, VFEND's revenue depends heavily on its efficacy, patent position, and competition within antifungal therapeutics.

Market Overview

Market Size and Growth

• The global antifungal market was valued at approximately $13.1 billion in 2022.
• Compound annual growth rate (CAGR) is forecasted at 6.5% through 2028 [1].
• The antifungal segment accounts for roughly 10% of the overall prescription drug market.

Leading Competitors

• Myconostica (Fungus-specific drugs)
• Basilea's isavuconazole
• Gilead's тарсовудин

VFEND maintains a competitive advantage through its broad spectrum and established efficacy data, though competition from newer azoles and echinocandins challenges its market share.

Revenue and Sales Dynamics

• In 2022, Pfizer reported VFEND sales of approximately $600 million globally.
• The U.S. accounts for roughly 70% of sales, with ongoing expansion into emerging markets.
• Sales volatility relates to treatment guidelines favoring newer agents and resistance development.

Patent and Regulatory Status

• Pfizer's patent for VFEND extends until 2025 within key markets.
• Patent expiry poses a near-term risk for generic erosion.
• Regulatory approvals remain robust; no generic versions available yet in major markets.

Clinical and Therapeutic Fundamentals

Efficacy Profile

• Proven to treat invasive aspergillosis effectively.
• Superior penetration into the central nervous system aids in meningitis cases.
• Has a recommended dose of 6 mg/kg every 12 hours for the first 24 hours, then 4 mg/kg twice daily.

Safety and Tolerability

• Side effects include visual disturbances, elevated liver enzymes, and phototoxicity.
• Monitoring reduces adverse events.

Resistance and Challenges

• Emerged resistance in some Candida and Aspergillus strains.
• Resistance threatens future sales longevity.

Regulatory and IP Outlook

• Pfizer's patent protection is crucial for maintaining exclusivity until late 2025.
• Patent challenges or extensions depend on legal and regulatory strategies.
• Patent cliff expected by 2026 could impact revenues unless shifted by new formulations or indications.

R&D and Pipeline Potential

• Ongoing studies focus on new indications and formulations.
• No approved follow-on drugs specific to VFEND's pipeline as of 2023.
• Pfizer might leverage existing respiratory and invasive fungal infection trials for future expansion.

Investment Risks and Opportunities

Risks

• Patent expiry reduces exclusivity, increasing generic competition.
• Market share erosion from newer therapies (e.g., isavuconazole).
• Resistance development might limit prescribing.

Opportunities

• Market expansion in emerging regions.
• Label expansions for new indications.
• Potential for reformulations to extend patent life.

Financial Outlook and Valuation

• Current valuation reflects patent life, market share, and resistance trends.
• Revenue is expected to decline post-2025 unless significant pipeline or new indications emerge.
• Investment appeal depends on Pfizer's strategic response to patent expiration and competitive threats.

Key Takeaways

• VFEND is a mature product with solid efficacy but faces patent expiration in 2025.
• The antifungal market offers growth but with rising competition and resistance risks.
• Pfizer's pipeline and market expansion strategies are critical factors influencing future value.
• Revenue exposure is concentrated in the U.S.; diversification in emerging markets could mitigate risk.
• Long-term investment hinges on Pfizer's ability to defend or extend VFEND's market position and develop new therapies.

FAQs

1. When will VFEND face generic competition?
Patent protections expire in major markets around 2025, with patent exclusivity potentially ending by then, paving the way for generics.

2. How does VFEND compare to newer antifungal agents?
VFEND has a broad spectrum and proven efficacy, but newer azoles like isavuconazole may offer improved safety profiles and resistance resistance.

3. What factors could extend VFEND's market dominance?
Label expansions, new formulations, and indications, as well as strategic patent litigations, could prolong its market exclusivity.

4. How significant is resistance development for VFEND?
While resistance has emerged in some strains, it remains manageable. Ongoing surveillance is critical for maintaining efficacy.

5. What is Pfizer's strategy regarding VFEND beyond patent expiry?
Investing in pipeline developments, potential formulation reformulations, and expanding indications are primary strategies.

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Sources

[1] Grand View Research. Antifungal Market Size, Share & Trends Analysis Report 2022-2028.