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-five 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:	127
Patent Applications:	5,426
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	INJECTABLE;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	INJECTABLE;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	INJECTABLE;INTRAVENOUS	021267-001	May 24, 2002
Pf Prism Cv	VFEND	voriconazole	INJECTABLE;INTRAVENOUS	021267-001	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

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/000387 Voriconazole, 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/002669 Voriconazole 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/003737 Voriconazole 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
Indonesia	22939
World Intellectual Property Organization (WIPO)	9111172
Yugoslavia	17591
Egypt	23910	Pharmaceutical formulations containing voriconazole
Australia	646020
Hungary	211582
Canada	2119154	DERIVES DE CYCLODEXTRINES A SOLUBILITE AQUEUSE ACCRUE ET LEUR UTILISATION (DERIVATIVES OF CYCLODEXTRINS EXHIBITING ENHANCED AQUEOUS SOLUBILITY AND THE USE THEREOF)

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
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	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

VFEND Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VFEND (Voriconazole)

Introduction to VFEND (Voriconazole)

VFEND, known generically as voriconazole, is a synthetic antifungal drug that belongs to the second-generation broad-spectrum triazole derivatives. It works by inhibiting the cytochrome P450-dependent enzyme 14-alpha sterol demethylase, which is crucial for fungal cell membrane integrity, thereby hindering fungal growth[1].

Market Growth and Outlook

The voriconazole market has demonstrated significant growth in recent years. Here are some key points highlighting its market dynamics and financial trajectory:

Global Market Size and Growth

The global voriconazole API market is expected to experience substantial growth. As of 2023, the market size was valued at over $12.59 billion and is projected to reach $18.76 billion by 2028, with a compound annual growth rate (CAGR) of 8.31%[1].

Regional Market Performance

The market is expected to see robust growth in various regions, particularly in Latin America and the Asia-Pacific. These regions are emerging as significant contributors due to increasing demand and the rise of outsourcing manufacturing to these areas, which offers cost benefits and access to skilled workforces[1].

Key Drivers of Growth

Several factors are driving the growth of the voriconazole market:

• Increasing Demand: The growing need for effective antifungal treatments, especially for severe and invasive fungal infections, is a major driver.
• Outsourcing Manufacturing: Many companies are outsourcing production to regions with lower costs and skilled labor, creating a win-win situation for both suppliers and buyers[1].
• Technological Advancements: Continuous technological advancements in manufacturing units and strict compliance with regulatory standards are also contributing to the market's growth[1].

Financial Performance and Projections

Here are some financial highlights and projections for the voriconazole market:

Revenue Growth

The voriconazole API market has surpassed significant revenue milestones. For instance, the market grew from a relatively small base to over $10 million within three years starting from 2020[1].

Future Projections

The market is expected to continue its upward trajectory, driven by the increasing demand for antifungal treatments and the expansion of manufacturing capabilities. The CAGR of 16.71% projected until 2030 indicates a highly promising future for the voriconazole market[4].

Competitive Landscape

The competitive landscape of the voriconazole market is characterized by:

• Key Players: Major pharmaceutical companies, including those involved in outsourcing manufacturing, play a significant role. These companies are focused on maintaining high standards of quality and compliance with regulatory requirements[4].
• Market Segmentation: The market is segmented based on product type, application, and geography. Understanding these segments helps in projecting the market size and identifying growth opportunities[4].

Regulatory Compliance and Manufacturing

Regulatory compliance is a critical aspect of the voriconazole market. Companies must strictly adhere to industry regulations, ensuring that their outsourcing partners also comply with these standards. This focus on compliance, coupled with technological advancements in manufacturing units, is essential for sustaining growth in the global market[1].

Impact of COVID-19

While the COVID-19 pandemic had a significant impact on various pharmaceutical markets, the voriconazole market has shown resilience. The pandemic highlighted the importance of antifungal treatments, especially in patients with compromised immune systems, thereby supporting the market's growth[4].

Quotes from Industry Experts

Industry experts emphasize the importance of continuous research and development in maintaining the market's growth trajectory. For example:

"The present research study on the market scenario of the Voriconazole API proves to be promising, and the continuous efforts put by the companies for sustenance in the global market are worth studying and appreciating the efforts put by the R&D striving for patient compliance in formulation development for the treatment of deadly fungal infections and strive for early recovery is the motive of the research studies."[1]

Illustrative Statistics

• Market Size: Expected to grow from $12.59 billion in 2023 to $18.76 billion by 2028[1].
• CAGR: Projected at 8.31% from 2023 to 2028 and 16.71% until 2030[1][4].
• Regional Growth: Significant growth anticipated in Latin America and the Asia-Pacific regions[1].

Challenges and Opportunities

While the voriconazole market is poised for growth, it also faces several challenges and opportunities:

• Challenges: Regulatory compliance, competition from generic drugs, and the need for continuous innovation to stay ahead in the market.
• Opportunities: Increasing demand for antifungal treatments, emerging markets, and the potential for new formulations and applications[4].

Key Takeaways

• The voriconazole market is experiencing significant growth driven by increasing demand and outsourcing manufacturing.
• The market is projected to reach $18.76 billion by 2028 with a CAGR of 8.31%.
• Regulatory compliance and technological advancements are crucial for sustaining growth.
• The market faces challenges such as competition and regulatory hurdles but offers opportunities in emerging markets and new formulations.

FAQs

What is the current market size of the voriconazole API market?

The current market size of the voriconazole API market was valued at over $12.59 billion in 2023[1].

What is the projected CAGR for the voriconazole market until 2030?

The projected CAGR for the voriconazole market until 2030 is 16.71%[4].

Which regions are expected to contribute significantly to the growth of the voriconazole market?

Latin America and the Asia-Pacific regions are expected to contribute significantly to the growth of the voriconazole market[1].

What are the key drivers of growth for the voriconazole market?

Key drivers include increasing demand for antifungal treatments, outsourcing manufacturing, and technological advancements in manufacturing units[1].

What challenges does the voriconazole market face?

The market faces challenges such as regulatory compliance, competition from generic drugs, and the need for continuous innovation[4].

How does the voriconazole market benefit from outsourcing manufacturing?

Outsourcing manufacturing to regions with lower costs and skilled labor creates a win-win situation for both suppliers and buyers, contributing to the market's growth[1].

Sources

1. Medwin Publishers: "Voriconazole (API): Global Market Growth Study Report"[1].
2. Pfizer: "Pfizer Reports First-Quarter 2023 Results"[2].
3. Pfizer: "Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Guidance"[3].
4. OpenPR: "Voriconazole Vfend Market is Likely to Increase at a Significantly High CAGR during Forecast Period 2030"[4].