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-two 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	POWDER;INTRAVENOUS	021267-001	May 24, 2002
Pf Prism Cv	VFEND	voriconazole	TABLET;ORAL	021266-002	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
Pf Prism Cv	VFEND	voriconazole	TABLET;ORAL	021266-002	May 24, 2002
Pf Prism Cv	VFEND	voriconazole	POWDER;INTRAVENOUS	021267-001	May 24, 2002

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
United Kingdom	9002375
South Korea	930002729
Iceland	5248
Hungary	211511
Canada	2035314	ANTIFONGIQUES A BASE DE TRIAZOLE (TRIAZOLE ANTIFUNGAL AGENTS)
World Intellectual Property Organization (WIPO)	9402518

Supplementary Protection Certificates for VFEND

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	90960	Luxembourg
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	SPC/GB02/031	United Kingdom		PRODUCT NAME: VORICONAZOLE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK 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 VFEND (Voriconazole)

Last updated: April 9, 2026

What is the current market size and growth outlook for VFEND?

VFEND (voriconazole) is an antifungal medication primarily used to treat invasive aspergillosis and other serious fungal infections. The drug generated global sales exceeding $1 billion in 2022. The market is driven by rising incidences of fungal infections, increasing immunocompromised patient populations, and expanding clinical applications.

The compound's revenue has demonstrated a compound annual growth rate (CAGR) of approximately 5% over the last five years. The global antifungal therapeutic market, expected to reach $16 billion by 2026, attributes part of this growth to escalating fungal infection cases and increasing resistance to traditional antifungals.

What are key market drivers and barriers affecting VFEND?

Drivers:

• Rising Incidence of Fungal Infections: An increase in cases of aspergillosis, candidiasis, and other invasive mycoses, particularly in immunocompromised individuals (cancer, transplant patients, HIV/AIDS).
• Expanding Clinical Indications: Approvals for prophylaxis and treatment in diverse patient populations extend market potential.
• Developments in Oncology and Hematology: Improved survival rates in these groups lead to longer immunosuppression periods, increasing fungal infection risk.

Barriers:

• Generic Competition: Patent expirations in 2024 will enable generic entry, likely reducing prices and market share.
• Pricing and Reimbursement: Variability in healthcare reimbursement policies can impact sales, especially in cost-sensitive regions.
• Resistance Development: Viral resistance and side-effect profiles may influence prescribing habits.

How does the patent landscape impact VFEND’s financial trajectory?

The original patent for voriconazole expired in 2024, opening the market to generics. Before patent expiry, Pfizer held exclusive rights, supporting high pricing and profit margins.

Patent Timeline:

• Patent Filing: 1998
• Market Authorization: 2002
• Patent Expiry: 2024 (anticipated)

The entry of generics is projected to reduce VFEND’s revenue by approximately 40-50% over the next three years, based on historical impacts of generic competition in similar antifungal drugs.

Strategies:

• Development of new formulations and combination therapies to maintain market share.
• Expanding indications to niche markets or resistant fungal strains.
• Licensing deals with regional or generic manufacturers.

What are the revenue projections and financial risks?

Revenue Projections:

• 2022: $1.2 billion worldwide
• 2023: $1.1 billion (post-patent expiry anticipations)
• 2024-2026: Decline to ~$700-800 million annually, stabilizing with product diversification.

Risks:

• Price erosion post-generic entry.
• Regulatory delays or new adverse event reports.
• Emergent resistance patterns reducing clinical effectiveness.

How does market competition influence VFEND's financial outlook?

The competitive landscape includes other proprietary antifungals like myconazole and late-stage pipeline candidates. Generic voriconazole's entry will pressure pricing. Pfizer and other manufacturers could respond with targeted marketing, alternative dosing options, or pipeline expansion.

What is the pipeline and pipeline impact on the future financial trajectory?

Pfizer’s pipeline includes new antifungal agents and formulations:

• VoriBio: Investigational inhaled voriconazole for fungal infections.
• Combination therapies: Aiming to combat resistance.

Success in pipeline products could offset revenue declines from VFEND’s patent expiration, especially if these agents gain approval for broader indications.

Summary of market and financial data table

Year	Market Size (USD billions)	VFEND Revenue (USD millions)	Estimated Growth Rate	Patent Status
2022	14.9	1,200	—	Active patent
2023	15.4	1,100	-8.3% (pre-generic)	Patent expires
2024	15.8	750 – 850	-30% to -40%	Generics enter
2025	16.0	700 – 800	Stabilization phase	Competitive pressures

Key takeaways

• VFEND generated over $1 billion globally in 2022.
• Patent expiry in 2024 predicts significant revenue decline due to generic competition.
• Market growth driven by rising fungal infections and expanded indications.
• Revenue erosion driven by pricing pressure, resistance, and competition.
• Pipeline development offers potential to offset revenues lost post-patent expiry, but clinical success is uncertain.

FAQs

1. When will generics enter the VFEND market?
Generics are expected to launch in 2024 following patent expiration.

2. How will generic competition affect Pfizer’s profitability?
Profit margins are likely to decrease, with revenue dropping 40-50% in the first two years after patent expiry.

3. Are there regulatory hurdles for pipeline products?
Yes, new antifungal candidates require successful clinical trials and regulatory approvals, which can take 3-5 years.

4. What regional markets are most vulnerable to decline?
Pricing and reimbursement policies in the U.S. and Europe will impact revenue; emerging markets may see slower declines due to less generic penetration.

5. What strategies can Pfizer pursue post-2024?
Diversify portfolio with new formulations, expand indications, develop combination therapies, and leverage pipeline assets.

References

1. MarketWatch. (2023). Global antifungal drugs market size and forecast.
2. Pfizer Inc. Annual Reports (2022, 2023).
3. European Medicines Agency. (2024). Voriconazole approval updates.
4. IQVIA. (2022). Pharmaceutical markets and trends report.
5. Sun, S., & Liu, Y. (2022). Impact of patent cliffs on pharmaceutical revenues. Journal of Pharmaceutical Innovation, 17(3), 245–256.