ITRACONAZOLE - Generic Drug Details

What are the generic drug sources for itraconazole and what is the scope of freedom to operate?

Itraconazole is the generic ingredient in four branded drugs marketed by Accord Hlthcare, Alembic, Alkem Labs Ltd, Amneal Pharms, Jubilant Generics, Mylan Pharms Inc, Rising, Sandoz, Strides Pharma, Torrent, Zydus Pharms, Janssen Pharms, Mayne Pharma, Annora Pharma, Apotex, and Sebela Ireland Ltd, and is included in nineteen NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Itraconazole has twenty-six patent family members in eleven countries.

There are fifteen drug master file entries for itraconazole. Nineteen suppliers are listed for this compound.

Summary for ITRACONAZOLE

International Patents:	26
US Patents:	6
Tradenames:	4
Applicants:	16
NDAs:	19
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	389
Patent Applications:	5,511
Drug Prices:	Drug price trends for ITRACONAZOLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ITRACONAZOLE
What excipients (inactive ingredients) are in ITRACONAZOLE?	ITRACONAZOLE excipients list
DailyMed Link:	ITRACONAZOLE at DailyMed

See drug prices for ITRACONAZOLE

Recent Clinical Trials for ITRACONAZOLE

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

Sponsor	Phase
Emalex Biosciences Inc.	Phase 1
Syneos Health	Phase 1
Cambridge Cognition Ltd	Phase 1

See all ITRACONAZOLE clinical trials

Pharmacology for ITRACONAZOLE

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

Medical Subject Heading (MeSH) Categories for ITRACONAZOLE

14-alpha Demethylase Inhibitors

Antifungal Agents

Cytochrome P-450 CYP3A Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ITRACONAZOLE

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 ITRACONAZOLE

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 ITRACONAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes			Y
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes
Amneal Pharms	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	205080-001	Sep 26, 2016	AB	RX	No	No
Apotex	ITRACONAZOLE	itraconazole	SOLUTION;ORAL	208481-001	Aug 2, 2019		DISCN	No	No

Expired US Patents for ITRACONAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	SPORANOX	itraconazole	INJECTABLE;INJECTION	020966-001	Mar 30, 1999
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997
Janssen Pharms	SPORANOX	itraconazole	INJECTABLE;INJECTION	020966-001	Mar 30, 1999

EU/EMA Drug Approvals for ITRACONAZOLE

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 ITRACONAZOLE

Country	Patent Number	Title	Estimated Expiration
Japan	2018162304	イトラコナゾール組成物及び投与剤形、並びにその使用方法 (ITRACONAZOLE COMPOSITIONS AND DOSAGE FORMS, AND METHODS OF USING THE SAME)
Japan	2015531749	イトラコナゾール組成物及び投与剤形、並びにその使用方法
Australia	2020217438	Itraconazole compositions and dosage forms, and methods of using the same
Mexico	366829	COMPOSICIONES Y FORMAS DE DOSIFICACION DE ITRACONAZOL Y METODOS DE USO DE LAS MISMAS. (ITRACONAZOLE COMPOSITIONS AND DOSAGE FORMS, AND METHODS OF USING THE SAME.)

ITRACONAZOLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Itraconazole

Introduction to Itraconazole

Itraconazole is a triazole antifungal drug widely used to treat various fungal infections, including those caused by Aspergillus, Candida, and Cryptococcus. Its efficacy and relatively lower side effect profile have made it a preferred choice among medical professionals[2].

Market Growth Drivers

Rising Incidence of Fungal Infections

The global rise in fungal infections, particularly in tropical regions and among immunocompromised populations, is a significant driver of the Itraconazole market. Approximately 1.5 million deaths annually are attributed to invasive fungal diseases, highlighting the urgent need for effective treatments[2].

Innovative Formulations

Recent advancements in drug formulation have improved the efficacy and safety profile of Itraconazole. New oral solutions and injectables, including lipid-based formulations, enhance absorption and reduce side effects, making the drug more effective against resistant fungal strains[2].

Increased Investment in Research and Development

Pharmaceutical companies are investing heavily in R&D to explore new indications for Itraconazole, such as its potential role in treating COVID-19-related fungal infections. This investment could open new avenues for market growth[2].

Market Segmentation

By Form

The Itraconazole market is segmented into tablets and capsules. The development of new formulations, such as oral solutions and injectables, is also contributing to market growth[1].

By Distribution Channel

The market is segmented into hospital pharmacies, retail pharmacies, and others. This segmentation helps in understanding the different channels through which Itraconazole is distributed and consumed[1].

By Application Site

The market can be segmented based on the site of infection, such as mouth & throat, lungs, and toe & fingernail infections. The mouth & throat infection segment is expected to contribute significantly to the market revenue[4].

By Route of Administration

The market is bifurcated into intravenous administration and oral intake. Oral administration, particularly through capsules, holds the largest share due to its availability, cost, and patient preference[4].

Geographical Analysis

The Itraconazole market is analyzed across regions including North America, Europe, APAC, MEA, and South & Central America. North America, particularly the US and Canada, is a major contributor due to the high prevalence of fungal infections. However, the Asia-Pacific region is expected to be a hub of opportunities due to extensive incidence of lung infections and high drug penetration trends[1][4].

Financial Trajectory

Market Size and Growth Rate

The Itraconazole market is projected to grow at an annual rate of 5-7% over the next decade. The market size is expected to reach several billion dollars by the end of the decade, reflecting significant growth driven by rising healthcare expenditures and increasing awareness of fungal infections[2].

Revenue Forecast

The global Itraconazole market reached a value of USD XX billion in 2023 and is anticipated to attain USD XX billion by 2031, exhibiting a substantial growth trajectory[3].

CAGR and Historical Data

The market is expected to rise at a CAGR of around 5-7% from 2023 to 2031. Historical data from 2021-2022 provides a baseline for understanding the market's growth pattern[1].

Challenges and Restraints

Antifungal Resistance

The rise of antifungal resistance is a significant concern, as some fungal strains have developed resistance to existing treatments. This could impact the market's growth prospects[2].

Regulatory Hurdles

Regulatory hurdles and the need for extensive clinical trials can slow down the introduction of new formulations, posing a challenge to the market's growth[2].

Strategic Partnerships and Mergers & Acquisitions

Strategic partnerships between biotech firms and established pharmaceutical companies are accelerating the development of next-generation antifungal therapies. Mergers and acquisitions are also prevalent, as companies look to consolidate resources and enhance their product offerings[2].

Investment Opportunities

The Itraconazole market presents robust investment opportunities due to its expanding patient base, increasing awareness of fungal infections, and ongoing innovations in treatment options. Investors can capitalize on the demand for effective antifungal treatments, making this market particularly attractive[2].

Competitor Analysis

The market includes both generic and branded Itraconazole API drugs. Generic medications are expected to have a larger share in the overall industry, especially in the Asia-Pacific region[4].

Key Takeaways

• The Itraconazole market is driven by the rising incidence of fungal infections and innovative drug formulations.
• The market is segmented by form, distribution channel, application site, and route of administration.
• North America and the Asia-Pacific region are key geographical markets.
• The market faces challenges such as antifungal resistance and regulatory hurdles.
• Strategic partnerships and mergers & acquisitions are reshaping the market landscape.
• The market offers attractive investment opportunities due to its growing demand and innovative treatments.

FAQs

Q: What are the primary drivers of the Itraconazole market? A: The primary drivers include the rising incidence of fungal infections, innovative drug formulations, and increased investment in research and development.

Q: How is the Itraconazole market segmented? A: The market is segmented by form (tablets and capsules), distribution channel (hospital pharmacies, retail pharmacies), application site (mouth & throat, lungs, etc.), and route of administration (intravenous and oral).

Q: Which regions are key contributors to the Itraconazole market? A: North America, particularly the US and Canada, and the Asia-Pacific region are significant contributors.

Q: What challenges does the Itraconazole market face? A: The market faces challenges such as antifungal resistance, regulatory hurdles, and the need for extensive clinical trials.

Q: What investment opportunities are available in the Itraconazole market? A: The market offers robust investment opportunities due to its expanding patient base, increasing awareness of fungal infections, and ongoing innovations in treatment options.

Cited Sources

1. The Insight Partners - Itraconazole Market Strategies and Share 2031
2. Market Research Intellect - Itraconazole Market Size And Projection
3. Market Research Intellect - Itraconazole Sales Market Size, Scope And Forecast Report
4. Global Market Estimates - Global Itraconazole API Market Analysis | Size & Forecasts