SPORANOX Drug Patent Profile

When do Sporanox patents expire, and what generic alternatives are available?

Sporanox is a drug marketed by Janssen Pharms and is included in three NDAs.

The generic ingredient in SPORANOX is itraconazole. There are fifteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sporanox

A generic version of SPORANOX was approved as itraconazole by SANDOZ on May 28^th, 2004.

Summary for SPORANOX

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	40
Patent Applications:	3,851
Drug Prices:	Drug price information for SPORANOX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SPORANOX
What excipients (inactive ingredients) are in SPORANOX?	SPORANOX excipients list
DailyMed Link:	SPORANOX at DailyMed

See drug prices for SPORANOX

Recent Clinical Trials for SPORANOX

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

Sponsor	Phase
University of Chicago	Phase 1
Arvinas Estrogen Receptor, Inc.	Phase 1
Postgraduate Institute of Medical Education and Research	N/A

See all SPORANOX clinical trials

Pharmacology for SPORANOX

Drug Class	Azole Antifungal
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Paragraph IV (Patent) Challenges for SPORANOX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SPORANOX	Oral Solution	itraconazole	10 mg/mL	020657	1	2013-05-03

US Patents and Regulatory Information for SPORANOX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	SPORANOX	itraconazole	CAPSULE;ORAL	020083-001	Sep 11, 1992	AB	RX	Yes	Yes
Janssen Pharms	SPORANOX	itraconazole	INJECTABLE;INJECTION	020966-001	Mar 30, 1999		DISCN	No	No
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997	AA	RX	Yes	Yes

Expired US Patents for SPORANOX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997	4,791,111
Janssen Pharms	SPORANOX	itraconazole	INJECTABLE;INJECTION	020966-001	Mar 30, 1999	4,727,064
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997	4,727,064
Janssen Pharms	SPORANOX	itraconazole	CAPSULE;ORAL	020083-001	Sep 11, 1992	4,267,179
Janssen Pharms	SPORANOX	itraconazole	INJECTABLE;INJECTION	020966-001	Mar 30, 1999	6,407,079

EU/EMA Drug Approvals for SPORANOX

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Avimedical B.V.	Fungitraxx	itraconazole	EMEA/V/C/002722 For the treatment of aspergillosis and candidiasis in companion birds,	Authorised	no	no	no	2014-03-12

International Patents for SPORANOX

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

Country	Patent Number	Title	Estimated Expiration
Spain	2097536
South Korea	0151893
New Zealand	218553	((4-(4-(4-PHENYL-1-PIPERAZINYL)-PHENOXY METHYL)-1,3-DIOXOLAN-2-YL)-METHYL)-1H-IMIDAZOLE AND -1H-1,2,4 TRIAZOLE DERIVATIVES AS PHARMACEUTICALS
Japan	H07285963	SUBSTITUTED (4-PHENYL-1-PIPERAZINYL)PHENOL DERIVATIVE AND ITS PRODUCTION
Denmark	167356

Supplementary Protection Certificates for SPORANOX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0006711	SPC/GB93/038: EXPIRE	United Kingdom

SPORANOX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sporanox (Itraconazole)

Market Overview

Sporanox, known generically as itraconazole, is an antifungal medication used to treat a variety of fungal infections. The market for Sporanox is influenced by several key factors, including the prevalence of fungal infections, advancements in medical technology, and the competitive landscape.

Market Size and Growth

The global Sporanox market is projected to experience significant growth over the coming years. According to market research, the itraconazole market was valued at US$ 639.4 million in 2023 and is expected to grow at a Compound Annual Growth Rate (CAGR) of 2.8% from 2024 to 2034, reaching US$ 866.3 million by the end of 2034[4].

Regional Analysis

North America

North America dominates the itraconazole market, driven by continuous advancements in therapeutic treatments in the U.S. and Canada. This region is expected to maintain its dominance during the forecast period due to the high prevalence of fungal infections and advanced healthcare infrastructure[4].

Europe

Europe is another significant market for itraconazole, with countries like Germany, the U.K., France, Italy, and Spain contributing substantially to the regional market. The European market is driven by a strong healthcare system and increasing awareness about fungal infections[4].

Asia-Pacific, Latin America, and Middle East & Africa

These regions are expected to grow at a faster rate due to increasing healthcare spending, rising awareness about fungal infections, and expanding production capacities of key players. Companies are focusing on untapped geographies in these regions to expand their market presence[4].

Market Segmentation

By Form

Itraconazole is available in various forms, including capsules, tablets, creams, and injections. Capsules are the most commonly used form, followed by tablets. The market value forecast by form indicates a steady demand for these formulations[4].

By Application

The primary applications of itraconazole include gynecology, dermatology, and other fields such as ophthalmology. Dermatology accounts for a significant share due to the high incidence of skin-related fungal infections[4].

By Distribution Channel

Hospital pharmacies hold the largest share in the distribution of itraconazole, followed by retail pharmacies and online pharmacies. The convenience and accessibility of these channels contribute to their market dominance[4].

Key Drivers

Increasing Prevalence of Fungal Infections

The rise in fungal infections, particularly in immunocompromised patients, is a major driver of the itraconazole market. This increase is attributed to factors such as the growing number of patients with chronic diseases and the use of immunosuppressive therapies[4].

Extensive R&D Activities

Clinical-stage biopharmaceutical companies are developing new formulations of itraconazole, such as orally inhaled dry powder formulations, to treat conditions like Allergic Bronchopulmonary Aspergillosis (ABPA) in asthma patients. These innovations are expected to boost market growth[4].

Competitive Landscape

The itraconazole market is competitive, with key players including Janssen Pharmaceuticals, Mylan N.V., Smilax Laboratories Limited, Chongquing Huabang Shengkai Pharmaceutical Co. Ltd., and others. These companies are engaged in various strategies to expand their production and reach untapped markets[4].

Financial Trajectory

Revenue Growth

The revenue from itraconazole is expected to grow steadily over the forecast period. The market size is projected to increase from US$ 639.4 million in 2023 to US$ 866.3 million by 2034, indicating a robust financial trajectory[4].

Cost-Effectiveness

Studies have shown that itraconazole, compared to other antifungal agents like fluconazole, can be cost-effective in certain scenarios. For instance, a cost-effectiveness analysis revealed that posaconazole, another antifungal, is more cost-effective than itraconazole or fluconazole in patients with prolonged neutropenia, but itraconazole still offers significant cost savings in many cases[5].

Market Attractiveness Analysis

The market attractiveness analysis by region, form, application, and distribution channel indicates that North America and Europe are highly attractive due to their well-established healthcare systems and high demand for antifungal treatments. Hospital pharmacies remain the most attractive distribution channel due to their widespread presence and patient preference[4].

Challenges and Opportunities

Challenges

One of the challenges facing the itraconazole market is the potential for resistance and breakthrough infections. Continuous R&D is necessary to develop new formulations and ensure the efficacy of existing treatments.

Opportunities

The growing demand for antifungal medications in emerging markets presents a significant opportunity for expansion. Additionally, the development of new formulations and delivery methods, such as orally inhaled dry powder formulations, offers potential for market growth.

Key Takeaways

• The itraconazole market is expected to grow at a CAGR of 2.8% from 2024 to 2034.
• North America and Europe are the dominant regions, driven by advanced healthcare infrastructure and high prevalence of fungal infections.
• Hospital pharmacies account for the largest share in the distribution of itraconazole.
• Extensive R&D activities and increasing prevalence of fungal infections are key drivers of the market.
• The market is competitive, with several key players focusing on expanding production and reaching untapped markets.

FAQs

Q: What is the projected market size of itraconazole by 2034?

A: The itraconazole market is expected to reach US$ 866.3 million by 2034[4].

Q: Which region dominates the itraconazole market?

A: North America dominates the itraconazole market, followed by Europe[4].

Q: What are the primary applications of itraconazole?

A: The primary applications include gynecology, dermatology, and other fields such as ophthalmology[4].

Q: Which distribution channel holds the largest share in the itraconazole market?

A: Hospital pharmacies hold the largest share in the distribution of itraconazole[4].

Q: What are the key drivers of the itraconazole market?

A: The key drivers include the increasing prevalence of fungal infections and extensive R&D activities[4].

Sources

1. Market Research Future: Sporanox Market Size, Share, Trends Report 2032.
2. VIVUS: VIVUS Reports First Quarter 2020 Financial Results.
3. Market Research Intellect: Global Sporanox Market Size and Forecast.
4. Transparency Market Research: Itraconazole Market Size, Trends & Analysis - 2034.
5. PubMed: Comparative cost-effectiveness of posaconazole versus fluconazole.