VORICONAZOLE - Generic Drug Details

What are the generic sources for voriconazole and what is the scope of patent protection?

Voriconazole is the generic ingredient in two branded drugs marketed by Pf Prism Cv, Amneal Pharms, Hainan Poly, Novel Labs Inc, Rising, Almaject, Aspiro, Chartwell Rx, Eugia Pharma, Gland Pharma Ltd, Meitheal, Norvium Bioscience, Sandoz Inc, Slate Run Pharma, UBI, Zydus Pharms, Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Cadila, Epic Pharma Llc, Glenmark Pharms Ltd, Mylan Pharms Inc, Prinston Inc, and Teva Pharms, and is included in twenty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for voriconazole. Thirty-five suppliers are listed for this compound.

Summary for VORICONAZOLE

US Patents:	0
Tradenames:	2
Applicants:	24
NDAs:	29
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	153
Patent Applications:	7,024
Drug Prices:	Drug price trends for VORICONAZOLE
What excipients (inactive ingredients) are in VORICONAZOLE?	VORICONAZOLE excipients list
DailyMed Link:	VORICONAZOLE at DailyMed

See drug prices for VORICONAZOLE

Recent Clinical Trials for VORICONAZOLE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Post Graduate Institute of Medical Education and Research, Chandigarh	Phase 3
Gilead Sciences	Phase 1
RenJi Hospital	Phase 4

See all VORICONAZOLE clinical trials

Pharmacology for VORICONAZOLE

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

Medical Subject Heading (MeSH) Categories for VORICONAZOLE

14-alpha Demethylase Inhibitors

Antifungal Agents

Cytochrome P-450 CYP3A Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for VORICONAZOLE

J02AC	Triazole and tetrazole derivatives
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for VORICONAZOLE

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 VORICONAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Slate Run Pharma	VORICONAZOLE	voriconazole	INJECTABLE;INTRAVENOUS	211661-001	Nov 30, 2018	AP	RX	No	No
Sandoz Inc	VORICONAZOLE	voriconazole	INJECTABLE;INTRAVENOUS	090862-001	May 30, 2012	AP	RX	No	No
Novel Labs Inc	VORICONAZOLE	voriconazole	FOR SUSPENSION;ORAL	206799-001	May 31, 2016	AB	RX	No	No
Ajanta Pharma Ltd	VORICONAZOLE	voriconazole	TABLET;ORAL	206181-002	May 24, 2016	AB	RX	No	No
Norvium Bioscience	VORICONAZOLE	voriconazole	INJECTABLE;INTRAVENOUS	210849-001	Oct 11, 2022		DISCN	No	No

Expired US Patents for VORICONAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	VFEND	voriconazole	INJECTABLE;INTRAVENOUS	021267-001	May 24, 2002	5,773,443
Pf Prism Cv	VFEND	voriconazole	TABLET;ORAL	021266-002	May 24, 2002	5,364,938
Pf Prism Cv	VFEND	voriconazole	TABLET;ORAL	021266-001	May 24, 2002	5,567,817
Pf Prism Cv	VFEND	voriconazole	INJECTABLE;INTRAVENOUS	021267-001	May 24, 2002	5,116,844
Pf Prism Cv	VFEND	voriconazole	INJECTABLE;INTRAVENOUS	021267-001	May 24, 2002	5,567,817

EU/EMA Drug Approvals for VORICONAZOLE

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

VORICONAZOLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Voriconazole

Introduction to Voriconazole

Voriconazole is a second-generation triazole antifungal agent widely used for the treatment of various life-threatening fungal infections, including invasive aspergillosis, candidiasis, and rare mold infections. Its broad-spectrum antifungal activity has made it a critical therapeutic option in the management of these infections.

Global Market Size and Growth

The global voriconazole market is projected to experience significant growth over the forecast period from 2024 to 2031. The market size in 2023 was substantial, with a compound annual growth rate (CAGR) expected to be notable over the forecast period[1][4].

Market Drivers

Several key factors drive the growth of the voriconazole market:

• Increasing Prevalence of Invasive Fungal Infections: The global burden of invasive fungal infections, particularly among immunocompromised individuals such as those with hematological malignancies, organ transplants, and HIV/AIDS, is on the rise. This increasing prevalence drives the demand for effective antifungal therapies like voriconazole[4].
• Rising Awareness of Antifungal Stewardship: The importance of antifungal stewardship is becoming more recognized, leading to a greater emphasis on the use of effective and well-tolerated antifungal treatments[4].
• Need for Effective Treatment Options: The critical need for effective treatments for life-threatening fungal infections continues to drive the market growth[4].

Regional Analysis

The voriconazole market is geographically diverse, with different regions contributing significantly to its growth:

• North America: This region, particularly the United States, is expected to dominate the market due to the high prevalence of invasive fungal infections, well-established healthcare infrastructure, and the presence of leading pharmaceutical companies[4].
• Europe: Countries like Germany, the United Kingdom, and France have well-developed healthcare systems and a strong focus on managing invasive fungal infections, contributing to the market's growth in this region[4].
• Asia-Pacific: This region is expected to experience moderate growth driven by the increasing prevalence of invasive fungal infections, expanding healthcare infrastructure, and growing awareness among healthcare professionals and patients[4].

Market Segments and Applications

The market is characterized by diverse applications:

• Injection Segment: The injection segment accounted for a noticeable share of the global voriconazole market in 2023 and is projected to experience significant growth in the near future[1].
• Hospital Segment: The hospital segment is expected to expand at a significant CAGR, retaining its position throughout the forecast period[1].
• Pharmaceutical Grade Voriconazole: This segment is utilized in the development of various voriconazole-containing drug products, contributing to the market's growth[4].

Competitive Landscape

The voriconazole market is moderately competitive with both branded and generic API manufacturers:

• Key Players: Companies like Pfizer and GeneTech Pharm are focusing on strategy building to strengthen their product portfolios and expand their business in the global market[1].
• Product Quality and Regulatory Compliance: Manufacturers are emphasizing product quality, regulatory compliance, and effective supply chain management to maintain their market position[4].

Financial Performance and Revenue

The financial performance of the voriconazole market is robust:

• Revenue Growth: The market has seen significant revenue growth, with the injection segment and hospital segment contributing substantially to this growth[1].
• CAGR and Forecast: The market is expected to grow at a steady CAGR from 2024 to 2031, driven by the increasing demand for effective antifungal treatments[1][4].

Therapeutic Drug Monitoring (TDM) and Pharmacokinetics

Voriconazole's variable pharmacokinetics necessitate therapeutic drug monitoring (TDM) to optimize treatment outcomes:

• Pharmacokinetic Variability: The drug's serum concentrations can be highly variable in patients, making TDM crucial for treatment optimization and avoiding toxicity[3].
• Optimum Dosing Approach: Research aims to find the optimum dosing approach for voriconazole, especially in pediatric patients where pharmacokinetics can be highly variable[3].

Market Opportunities and Challenges

Opportunities

• Growing Burden of Invasive Fungal Infections: The increasing incidence and prevalence of invasive fungal infections present a significant opportunity for the growth of the voriconazole market[4].
• Product Innovations: Ongoing research and development efforts, as well as the successful commercialization of new voriconazole formulations or delivery methods, can contribute to the market's future growth[4].

Challenges

• Drug Resistance: Increasing drug resistance to antifungals is a global problem, requiring higher drug exposure to achieve treatment success while increasing the risk of toxicity[3].
• Regulatory and Reimbursement Challenges: The market is influenced by regulatory frameworks and reimbursement policies, which can vary significantly across different regions[4].

Key Takeaways

• The global voriconazole market is expected to grow significantly driven by the increasing prevalence of invasive fungal infections and the need for effective antifungal treatments.
• North America and Europe are anticipated to dominate the market due to their well-established healthcare infrastructure and high prevalence of invasive fungal infections.
• The market is moderately competitive, with a focus on product quality, regulatory compliance, and effective supply chain management.
• Therapeutic drug monitoring is crucial for optimizing voriconazole treatment due to its variable pharmacokinetics.

Frequently Asked Questions (FAQs)

1. What are the primary drivers of the voriconazole market?

The primary drivers include the increasing prevalence of invasive fungal infections, rising awareness of antifungal stewardship, and the need for effective and well-tolerated treatment options.

2. Which regions are expected to dominate the voriconazole market?

North America and Europe are expected to dominate the market due to their well-established healthcare infrastructure and high prevalence of invasive fungal infections.

3. Why is therapeutic drug monitoring (TDM) important for voriconazole?

TDM is important because voriconazole exhibits variable pharmacokinetics, and monitoring serum concentrations helps in optimizing treatment outcomes and avoiding toxicity.

4. What are the key market segments for voriconazole?

The key market segments include the injection segment and the hospital segment, with pharmaceutical grade voriconazole being utilized in various drug products.

5. What challenges does the voriconazole market face?

The market faces challenges such as increasing drug resistance to antifungals and varying regulatory and reimbursement policies across different regions.

Cited Sources:

1. Cognitivemarketresearch.com - Voriconazole Market Report 2024 (Global Edition)
2. Vertex Pharmaceuticals Incorporated - Vertex Reports Third-Quarter 2017 Financial Results
3. RUG.nl - Clinical Pharmacology & Therapeutic Drug Monitoring of Voriconazole
4. Datahorizzonresearch.com - Pharmaceutical Grade Voriconazole Market Size, Share, Growth, Trends, Statistics Analysis Report and By Segment Forecasts 2024 to 2033