ONMEL Drug Patent Profile

Which patents cover Onmel, and what generic alternatives are available?

Onmel is a drug marketed by Sebela Ireland Ltd and is included in one NDA. There is one patent protecting this drug.

This drug has eight patent family members in five countries.

The generic ingredient in ONMEL 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 Onmel

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

Summary for ONMEL

International Patents:	8
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	84
Patent Applications:	4,332
Drug Prices:	Drug price information for ONMEL
DailyMed Link:	ONMEL at DailyMed

See drug prices for ONMEL

US Patents and Regulatory Information for ONMEL

ONMEL is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sebela Ireland Ltd	ONMEL	itraconazole	TABLET;ORAL	022484-001	Apr 29, 2010		DISCN	Yes	No			Y

Expired US Patents for ONMEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sebela Ireland Ltd	ONMEL	itraconazole	TABLET;ORAL	022484-001	Apr 29, 2010
Sebela Ireland Ltd	ONMEL	itraconazole	TABLET;ORAL	022484-001	Apr 29, 2010
Sebela Ireland Ltd	ONMEL	itraconazole	TABLET;ORAL	022484-001	Apr 29, 2010

EU/EMA Drug Approvals for ONMEL

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 ONMEL

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

Country	Patent Number	Title	Estimated Expiration
Czech Republic	9801885
Japan	5763735
Czech Republic	293841	Částice s obsahem itrakonazolu (Particles containing itraconazole A)

ONMEL Market Analysis and Financial Projection Experimental

Antifungal Drugs Market Dynamics and Financial Trajectory: Focus on ONMEL

Introduction to Antifungal Drugs Market

The antifungal drugs market is a significant segment within the pharmaceutical industry, driven by the increasing prevalence of fungal infections. Here, we will delve into the market dynamics and financial trajectory, with a specific focus on ONMEL, a brand-name antifungal drug.

Market Size and Growth

The antifungal drugs market is projected to grow substantially over the coming years. As of 2024, the market size is estimated to be around USD 16.61 billion and is expected to reach USD 20.11 billion by 2029, growing at a CAGR of 3.9% during the forecast period[1][4].

Key Drivers of Market Growth

Several factors contribute to the growth of the antifungal drugs market:

• Increasing Prevalence of Fungal Infections: The rise in fungal infections, such as candidiasis, aspergillosis, and dermatophytosis, is a major driver. For instance, onychomycosis, a fungal infection of the nails, affects up to 14% of the global population[1].
• Growing Geriatric Population: An aging population is more susceptible to fungal infections, contributing to market growth[4].
• Rising Number of Immunocompromised Patients: Patients with weakened immune systems, such as those with HIV/AIDS or undergoing chemotherapy, are more prone to fungal infections[4].
• Over-the-Counter (OTC) Drugs: The increasing availability and use of OTC antifungal drugs like clotrimazole, econazole, and ketoconazole also drive market growth[1].

Regional Market Analysis

North America

North America holds the largest market share in the antifungal drugs market. The United States, in particular, faces significant challenges from fungal infections, including drug-resistant strains of Candida. This region is expected to continue its dominance due to high product development activities and the approval of new antifungal drugs, such as VIVJOA (oteseconazole capsules) approved by the FDA in April 2022[1].

Asia Pacific

The Asia Pacific region is the fastest-growing market for antifungal drugs. This growth is attributed to the increasing awareness of fungal infections, rising healthcare expenditure, and a large patient population[1][4].

Market Segmentation

The antifungal drugs market is segmented based on drug class, indication, infection type, and route of administration.

• Drug Class: Azoles, echinocandins, polyenes, and allylamines are the main drug classes. Azoles dominate the market with a 48.2% revenue share in 2023[4].
• Indication: Candidiasis, aspergillosis, dermatophytosis, and mucormycosis are key indications. Candidiasis accounted for USD 5.5 billion in revenue in 2023[4].

Financial Trajectory of Antifungal Drugs

Price Trends

The prices of brand-name prescription drugs, including antifungals, have seen significant increases. For example, 78% of brand-name drugs available since 2012 have seen their prices increase by more than 50%, and 44% have more than doubled in price[3].

Revenue Projections

The market is expected to grow from USD 16.61 billion in 2024 to USD 20.11 billion by 2029, with a CAGR of 3.9%. By 2032, the market is projected to reach USD 21.2 billion at a CAGR of 3.7% from 2024 to 2032[1][4].

ONMEL (Itraconazole) Market Dynamics

ONMEL, a brand-name version of itraconazole, is an azole antifungal drug used to treat various fungal infections, including onychomycosis and systemic fungal infections.

Market Position

ONMEL, being part of the azole class, benefits from the dominance of this class in the market. Azoles account for a significant share of the antifungal drugs market, making ONMEL a key player in this segment[4].

Pricing and Cost

Like other brand-name antifungal drugs, ONMEL has likely seen price increases over the years. The trend of increasing prices for brand-name drugs, often more than 50% over a few years, applies to many antifungals, including itraconazole-based drugs[3].

Competition and Market Share

The antifungal drugs market is characterized by low market concentration, indicating a competitive landscape. Major players such as Abbott Laboratories, Bayer AG, Merck & Co., Inc., Glenmark Pharmaceuticals Limited, and GSK plc compete in this space. ONMEL, as a brand-name drug, faces competition from both other brand-name and generic versions of itraconazole[1].

Challenges and Opportunities

Challenges

• Drug Resistance: The emergence of drug-resistant fungal strains poses a significant challenge to the effectiveness of antifungal drugs like ONMEL.
• Price Transparency: The increasing costs of brand-name drugs, including antifungals, necessitate greater price transparency and regulatory oversight[3].

Opportunities

• Growing Demand: The increasing prevalence of fungal infections and the growing geriatric population present opportunities for growth.
• New Product Launches: Continuous innovation and the approval of new antifungal drugs can drive market expansion and competition[1][4].

Key Takeaways

• The antifungal drugs market is expected to grow significantly, driven by increasing fungal infections and a growing geriatric population.
• North America holds the largest market share, while the Asia Pacific region is the fastest-growing.
• Azoles, including ONMEL, dominate the market in terms of revenue share.
• Price increases for brand-name drugs are a trend, with many drugs seeing more than 50% increases since 2012.
• The market faces challenges such as drug resistance and the need for price transparency.

FAQs

What is the current size of the antifungal drugs market?

The antifungal drugs market size is expected to reach USD 16.61 billion in 2024[1].

Which region has the largest share in the antifungal drugs market?

North America accounts for the largest market share in the antifungal drugs market[1].

What are the key drivers of the antifungal drugs market growth?

Key drivers include the increasing prevalence of fungal infections, a growing geriatric population, and the rising number of immunocompromised patients[1][4].

How have prices of brand-name antifungal drugs changed in recent years?

Prices of brand-name antifungal drugs have seen significant increases, with 78% of drugs available since 2012 increasing by more than 50%, and 44% more than doubling in price[3].

Which drug class dominates the antifungal drugs market?

The azole class dominates the antifungal drugs market, accounting for 48.2% of the revenue share in 2023[4].

Sources

1. Mordor Intelligence: Antifungal Drugs Market Size & Share Analysis - Growth Trends[1].
2. Health Service Executive: HSE Annual Report and Financial Statements 2021[2].
3. JAMA Network Open: Trends in Prices of Brand-Name Prescription Drugs in the United States[3].
4. Global Market Insights: Antifungal Drugs Market Size, Share & Growth Trends - 2032[4].
5. Boston Scientific: 2023 Performance Report[5].