VFEND Drug Patent Profile

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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 is one drug master file entry for this compound. Thirty-three 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:	6,499
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	FOR SUSPENSION;ORAL	021630-001	Dec 19, 2003
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

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
African Regional IP Organization (ARIPO)	104	Triazole antifungal agents.
African Regional IP Organization (ARIPO)	8900135
Argentina	246963	UN PROCEDIMIENTO PARA LA PREPARACION DE NUEVOS DERIVADOS DE TRIAZOL. (A PROCEDURE FOR THE PREPARATION OF NEW TRIAZOLE DERIVATIVES.)
Austria	101600
Australia	3893089

Supplementary Protection Certificates for VFEND

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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

VFEND (Voriconazole) Market Dynamics, Patent Expiry, Generic Competition, and Financial Trajectory

Last updated: October 3, 2026

VFEND is Pfizer’s branded formulation of voriconazole, a triazole antifungal used for invasive aspergillosis and serious infections caused by Scedosporium apiospermum and Fusarium species. Its U.S. market exclusivity ended after the core patent and regulatory protection periods, and generic voriconazole now supplies most volume. Pfizer’s commercial exposure has shifted from a branded, hospital-driven product to a mature generic market with limited originator pricing power.

What is VFEND and how is voriconazole used?

VFEND contains voriconazole, a broad-spectrum triazole that inhibits fungal CYP51 and reduces ergosterol synthesis. The FDA approved VFEND in 2002 for serious invasive fungal infections where treatment options were limited. [1]

What formulations does VFEND have?

Formulation	Typical use	Commercial and technical considerations
50 mg and 200 mg tablets	Step-down and outpatient therapy	Generic substitution is widespread
40 mg/mL oral suspension after reconstitution	Patients unable to swallow tablets	Formulation and dosing accuracy matter
200 mg intravenous formulation	Initial treatment and hospitalized patients	Requires renal-function and excipient assessment

The injectable product uses sulfobutyl ether beta-cyclodextrin sodium as a solubilizing excipient. Accumulation of this excipient is a concern in severe renal impairment, which can influence selection of oral therapy. Voriconazole also has substantial drug-interaction, hepatic-monitoring, visual-disturbance, and therapeutic-drug-monitoring requirements. [1]

What diseases does VFEND treat?

FDA-labeled indications include:

• Invasive aspergillosis
• Serious infections caused by Scedosporium apiospermum
• Serious infections caused by Fusarium species
• Certain serious Candida infections in specified clinical settings

Voriconazole is used heavily in transplant medicine, hematologic malignancy, intensive care, and other immunocompromised populations. Clinical demand is tied to invasive fungal disease incidence, hospital formularies, antifungal stewardship, resistance patterns, and availability of alternatives such as isavuconazole, posaconazole, amphotericin B, and echinocandins.

When did VFEND lose exclusivity?

VFEND lost practical U.S. exclusivity after the expiration of its core patent protection and the arrival of generic ANDA products. The FDA approved the originator in May 2002. New chemical entity exclusivity generally protected the product from ANDA approval for five years, while orphan-drug protection may have applied to specific indications for seven years. [1, 2]

VFEND exclusivity timeline

Event	Approximate timing	Market effect
U.S. FDA approval	May 2002	Launch of branded voriconazole
New chemical entity exclusivity	Through approximately 2007	Delayed ANDA approval
Orphan-related protection for qualifying indications	Through approximately 2009	Limited indication-specific competition
Core compound patent period	Approximately 2010	End of principal small-molecule protection
Generic approvals and launches	Beginning in the early 2010s	Rapid price and share erosion
Current market	Mature generic market	Pfizer brand has limited pricing leverage

The precise date on which a particular generic could launch depended on ANDA litigation, any pediatric exclusivity, patent certifications, and settlement terms. The commercial result was clear: generic voriconazole became available after the principal protection period.

What patents protect VFEND?

VFEND was protected primarily by small-molecule compound patents and related pharmaceutical patent families. The strongest historical protection covered voriconazole itself rather than a complex biologic manufacturing process.

What patent types were relevant?

Patent category	Strategic value	Current relevance
Voriconazole compound patents	Protected the active molecule	Largely expired
Salt, stereochemical, or crystalline-form patents	Could protect specific solid forms	Limited effect after broad compound expiry
Tablet and oral-suspension formulation patents	Could protect excipient or dosage-form combinations	Generally weaker than compound protection
Injectable formulation patents	Could cover solubilized IV presentations	May affect individual products, not the entire molecule
Method-of-use patents	Could cover selected fungal infections or dosing methods	Usually narrower and vulnerable to design-around
Manufacturing patents	Could cover synthetic routes or intermediates	Relevant to API suppliers but not usually a barrier to all generics

The commercially decisive right was the basic compound protection. Once that protection expired, formulation and method patents could not preserve monopoly control over all voriconazole products unless they were both valid and enforceable against the proposed generic product.

What is the Orange Book status of VFEND?

VFEND’s U.S. products are associated with FDA-approved tablet, oral-suspension, and injectable presentations. The Orange Book identifies listed patents and regulatory exclusivities for approved products, but the active commercial significance of the historical VFEND listings is limited because generic voriconazole products have been approved for the same dosage forms. [2]

Orange Book analysis should distinguish:

1. Patents listed against the reference listed drug.
2. Patents that have expired.
3. Patents that remain listed but do not block approval because of litigation outcomes or certification status.
4. Product-specific patents that do not cover every dosage form.

The Orange Book is not a complete record of every patent that may be asserted in litigation. Unlisted manufacturing, contractual, trade-secret, or process rights can still affect supply without creating an Orange Book barrier. [2]

Which companies challenged VFEND patents?

Generic competition arose through ANDA filings by multiple manufacturers. FDA-approved generic suppliers have included large multinational and specialty-generic companies, with supplier participation changing over time as contracts, shortages, and price erosion affected market economics.

How did Paragraph IV challenges affect VFEND?

Paragraph IV certification allows an ANDA applicant to assert that a listed patent is invalid, unenforceable, or will not be infringed by the proposed generic product. A Paragraph IV filing can trigger patent litigation and, in some cases, a 30-month stay of approval under the Hatch-Waxman framework. [3]

For VFEND, the principal commercial consequence was the eventual approval of generic products after the core patent period. Publicly available product and litigation records do not establish a continuing patent barrier capable of restoring broad originator exclusivity.

Were there VFEND settlement agreements?

Generic settlements may have governed launch timing for individual applicants, but settlement terms are not a substitute for the patent expiration analysis. The relevant question for current market exposure is whether any settlement still delays generic supply. Generic voriconazole is already commercially available, so no historical settlement appears to preserve a broad U.S. monopoly for Pfizer.

What is the FDA regulatory status of VFEND?

VFEND remains an FDA-approved reference product. The product label contains boxed and prominent warnings relating to hepatic toxicity, visual disturbances, serious dermatologic reactions, photosensitivity, QT prolongation, drug interactions, and the need for clinical monitoring. [1]

The FDA-approved generic products rely on ANDA pathways that establish pharmaceutical equivalence and bioequivalence to the reference listed drug. They do not require a new clinical efficacy program equivalent to the original NDA, although manufacturing controls and quality requirements remain material.

Is VFEND a biologic with biosimilar risk?

No. VFEND is a conventional small-molecule drug, not a biologic. It faces generic, not biosimilar, competition. The relevant FDA pathway is an ANDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act rather than a 351(k) biosimilar application.

What is the financial trajectory of VFEND?

VFEND generated substantial branded revenue during the 2000s and early 2010s, supported by hospital use, limited options for invasive mold infections, and premium pricing for the injectable and oral products. Pfizer’s annual reports identified VFEND among its established pharmaceutical products during portions of this period. [4]

VFEND financial trajectory

Period	Commercial position	Revenue pattern
2002-2007	Protected branded launch	Rapid adoption in invasive aspergillosis
2008-2010	Mature branded product	High-value hospital and specialist use
2011-2014	Generic entry and price erosion	Declining originator sales
2015 onward	Mature generic category	Limited standalone Pfizer exposure
Current market	Multi-supplier generic supply	Low originator pricing power

Public Pfizer reporting indicates that VFEND was a meaningful product during its protected period, with annual sales reaching the high hundreds of millions of dollars globally around the peak commercial years. After generic entry, sales declined materially as hospitals and distributors substituted lower-cost products. Pfizer later reported many mature products in aggregated portfolios rather than as separately disclosed brands, limiting the usefulness of recent standalone revenue estimates. [4]

What drives current voriconazole market demand?

The principal demand drivers are:

• Incidence of invasive aspergillosis and other serious mold infections.
• Growth in transplant and immunocompromised patient populations.
• Hospital antifungal protocols.
• Local resistance to azoles.
• Therapeutic-drug-monitoring capacity.
• Availability and price of posaconazole and isavuconazole.
• Generic shortages and API supply continuity.

Voriconazole retains clinical value despite genericization because it is established in treatment guidelines and has extensive clinical experience. Its disadvantages include nonlinear pharmacokinetics, interaction burden, visual effects, photosensitivity, hepatic toxicity, and resistance concerns.

How does VFEND compare with competing antifungals?

Drug	Class	Main commercial position	Competitive advantage	Limitation
Voriconazole / VFEND	Triazole	Mature generic	Established first-line role for invasive aspergillosis	Interactions, monitoring, toxicity
Posaconazole / Noxafil	Triazole	Branded and generic competition	Prophylaxis and broad mold coverage	Absorption and interaction issues
Isavuconazole / Cresemba	Triazole	Differentiated branded product	Predictable pharmacology and shorter QT effect	Premium price and patent exposure
Liposomal amphotericin B / AmBisome	Polyene	Hospital injectable	Broad activity and no azole cross-resistance	Nephrotoxicity and infusion burden
Echinocandins	Echinocandin	Hospital generic products	Safety and Candida efficacy	Limited mold activity

Voriconazole competes on clinical familiarity and cost. Isavuconazole competes on tolerability and drug-interaction positioning, while liposomal amphotericin B remains important when azole resistance or intolerance is a concern.

What generic launch scenarios exist for VFEND?

The main scenarios are:

1. Continued multi-source generic supply with low prices.
2. Temporary price increases caused by API or injectable-product shortages.
3. Stable oral-tablet demand with more volatile injectable demand.
4. Limited brand retention in hospitals that prefer Pfizer supply assurance or specific contracting terms.
5. Clinical substitution toward newer triazoles in patients with toxicity, interaction, or resistance concerns.

The probability of a broad branded re-expansion is low because the active ingredient is off-patent, generic products are established, and therapeutic alternatives constrain price increases.

How strong is the VFEND patent estate?

The historical estate was strong when the compound patent was active. Its current defensive strength is low for broad market exclusion because the principal molecule is off-patent and generic products are already approved.

Patent-strength assessment

Factor	Assessment
Core molecule	Expired or commercially exhausted
Formulation protection	Narrow and product-specific
Method-of-use protection	Narrow, indication-dependent
Manufacturing protection	Potentially relevant to suppliers, not broad market exclusivity
Generic substitution barrier	Low
Litigation-driven launch risk	Low for the overall market
Supply-chain risk	More relevant than patent risk

Geographic protection differs by country because patent filing, expiry, supplementary protection certificates, pediatric extensions, and regulatory exclusivity vary by jurisdiction. U.S. generic entry does not establish identical entry dates in Europe, Japan, Canada, or emerging markets.

What patent litigation affects VFEND today?

No continuing U.S. litigation appears to create a market-wide barrier to generic voriconazole. Historical Hatch-Waxman litigation was relevant to the timing of individual ANDA approvals, but the current commercial issue is competition among generic suppliers rather than protection of the Pfizer brand.

Manufacturing disputes, API quality findings, product recalls, and supply interruptions can still affect the market. Those issues are regulatory and operational risks, not evidence of renewed patent exclusivity.

Key Takeaways

• VFEND is Pfizer’s branded voriconazole product for serious invasive fungal infections.
• U.S. regulatory exclusivity began with the 2002 FDA approval and ended after the applicable NCE, orphan, and patent periods.
• Generic voriconazole entered the U.S. market in the early 2010s.
• The core compound patent created the main historical barrier; formulation, method, and manufacturing patents were narrower.
• VFEND is a small molecule and faces generic, not biosimilar, competition.
• Pfizer revenue declined sharply after generic entry, and recent standalone sales are generally not separately reported.
• Current value is driven by clinical familiarity, hospital protocols, generic pricing, supply reliability, and resistance management.
• Patent risk is low; API availability, quality compliance, and hospital contracting are more important current market risks.

FAQs

Is VFEND still sold by Pfizer?

VFEND remains an FDA-approved reference product, but most U.S. voriconazole volume is supplied by generic manufacturers. Pfizer’s current standalone commercial exposure is limited compared with the protected-brand period.

Can a generic manufacturer launch a new VFEND formulation?

A manufacturer may develop a new dosage form or formulation, but it must satisfy FDA requirements for the applicable pathway. A new formulation can face separate patent, bioequivalence, stability, and manufacturing issues even when the active ingredient is off-patent.

Does voriconazole have pediatric exclusivity?

Pediatric exclusivity can add six months to applicable FDA exclusivity or patent terms when granted. Its effect is product- and listing-specific and must be reviewed against the relevant Orange Book records and FDA pediatric determinations.

Which drug is the strongest commercial competitor to voriconazole?

Isavuconazole is the closest differentiated branded competitor in invasive mold disease. Posaconazole competes across prophylaxis and treatment settings, while liposomal amphotericin B remains important for resistant or azole-intolerant infections.

Could Pfizer regain VFEND market share through a new delivery system?

A new delivery system could create a separate commercial product, but it would not restore broad exclusivity for conventional voriconazole tablets, oral suspension, or injection. Success would depend on clinical differentiation, FDA approval, reimbursement, and protection of the new formulation.

References

1. U.S. Food and Drug Administration. (2023). VFEND (voriconazole) prescribing information.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
3. U.S. Food and Drug Administration. (2024). Abbreviated new drug application approvals and patent certifications.
4. Pfizer Inc. (2007-2023). Annual reports and Form 10-K filings.
5. U.S. Food and Drug Administration. (2002). VFEND approval letter and regulatory review materials.