EXTINA Drug Patent Profile

Which patents cover Extina, and when can generic versions of Extina launch?

Extina is a drug marketed by Norvium Bioscience and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Extina

A generic version of EXTINA was approved as ketoconazole by TARO on June 15^th, 1999.

Summary for EXTINA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	2
Patent Applications:	2,099
Drug Prices:	Drug price information for EXTINA
What excipients (inactive ingredients) are in EXTINA?	EXTINA excipients list
DailyMed Link:	EXTINA at DailyMed

See drug prices for EXTINA

Recent Clinical Trials for EXTINA

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

Sponsor	Phase
St. Louis University	N/A
Stiefel, a GSK Company	Phase 4
GlaxoSmithKline	Phase 4

See all EXTINA clinical trials

Paragraph IV (Patent) Challenges for EXTINA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EXTINA	Foam	ketoconazole	2%	021738	1	2009-07-30

US Patents and Regulatory Information for EXTINA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norvium Bioscience	EXTINA	ketoconazole	AEROSOL, FOAM;TOPICAL	021738-001	Jun 12, 2007		DISCN	Yes	No

Expired US Patents for EXTINA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Norvium Bioscience	EXTINA	ketoconazole	AEROSOL, FOAM;TOPICAL	021738-001	Jun 12, 2007	7,553,835
Norvium Bioscience	EXTINA	ketoconazole	AEROSOL, FOAM;TOPICAL	021738-001	Jun 12, 2007	8,026,238

EU/EMA Drug Approvals for EXTINA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
HRA Pharma Rare Diseases	Ketoconazole HRA	ketoconazole	EMEA/H/C/003906 Ketoconazole HRA is indicated for the treatment of endogenous Cushing’s syndrome in adults and adolescents above the age of 12 years.	Authorised	no	no	yes	2014-11-18

International Patents for EXTINA

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

Country	Patent Number	Title	Estimated Expiration
Australia	732456
Canada	2306560	COMPOSITION ANTIFONGIQUE TOPIQUE (TOPICAL ANTIFUNGAL COMPOSITION)
Japan	2001520184
Japan	4917204
Spain	2277394
World Intellectual Property Organization (WIPO)	9920250

Market Dynamics and Financial Trajectory for EXTINA

Introduction to EXTINA

EXTINA, a brand name for ketoconazole topical, is a widely used antifungal medication. It is available in formulations such as aerosol and foam, and is approved by the FDA for the treatment of various fungal infections.

Market Context: Antifungal Drugs

The antifungal drugs market is experiencing significant growth, driven by several key factors. The market is estimated to reach USD 16.61 billion in 2024 and is expected to grow at a CAGR of 3.9% to reach USD 20.11 billion by 2029[1].

Demand for Antifungal Drugs

The increasing incidence of fungal infections, such as onychomycosis, is a major driver of the market. For instance, onychomycosis affects up to 14% of the global population, with fungal toenail infections being more common than fingernail infections[1].

EXTINA's Position in the Market

EXTINA, as a topical antifungal, is part of the broader antifungal drugs market. However, its specific formulations have undergone changes. All the formulations of EXTINA, including the 2% aerosol and foam, have been discontinued as of the last update in November 2024[4].

Impact of Discontinuation

The discontinuation of EXTINA formulations can significantly impact its market presence and revenue. When a product is discontinued, it often leads to a shift in market share towards other available antifungal treatments. This can result in reduced sales and revenue for the manufacturer, NORVIUM BIOSCIENCE.

Alternative Antifungal Treatments

The market for antifungal drugs is competitive, with several other treatments available. For example, other OTC antifungal drugs like clotrimazole, econazole, and miconazole continue to gain popularity. New product launches, such as the advanced Supra Bioavailable Itraconazole capsules by Apex Labs, also contribute to the competitive landscape[1].

Regional Market Dynamics

North America, particularly the United States, is a significant market for antifungal drugs due to the high burden of fungal infections. The region is expected to witness significant growth driven by increasing company activities in product development and the rising incidence of fungal infections[1].

Financial Implications

The financial trajectory for EXTINA is likely to be negatively impacted by its discontinuation. Here are some key financial implications:

• Reduced Revenue: The discontinuation of EXTINA formulations will result in a decline in revenue for NORVIUM BIOSCIENCE.
• Market Share Shift: The market share that EXTINA held will likely be captured by other antifungal treatments, further reducing its financial contribution.
• Consumer Impact: Patients may need to switch to alternative treatments, which could affect their treatment outcomes and satisfaction.

Industry Trends and Competition

The antifungal drugs market is characterized by low market concentration, indicating a competitive landscape. Major players like Abbott Laboratories, Bayer AG, Merck & Co., Inc., Glenmark Pharmaceuticals Limited, and GSK plc are actively involved in product launches, mergers and acquisitions, and collaborations to enhance their market presence[1].

Regulatory Considerations

The FDA plays a crucial role in regulating antifungal drugs, including topical treatments like EXTINA. The approval and discontinuation of formulations are subject to FDA regulations, which can significantly impact the financial and market dynamics of these products[4].

Consumer Safety

The discontinuation of EXTINA also raises concerns about consumer safety. Patients are advised to be cautious when purchasing medications online to avoid counterfeit products, which can be potentially unsafe[4].

Key Takeaways

• Discontinuation Impact: The discontinuation of EXTINA formulations will lead to reduced revenue and market share for NORVIUM BIOSCIENCE.
• Market Competition: The antifungal drugs market is highly competitive, with other treatments gaining market share.
• Regional Dynamics: North America remains a significant market for antifungal drugs due to the high burden of fungal infections.
• Consumer Advice: Patients should be cautious when switching to alternative treatments and ensure they purchase from reputable sources.

FAQs

What is EXTINA used for?

EXTINA, a brand name for ketoconazole topical, is used for the treatment of various fungal infections.

Why has EXTINA been discontinued?

All formulations of EXTINA have been discontinued as of the last update in November 2024.

What are the financial implications of EXTINA's discontinuation?

The discontinuation will result in reduced revenue for NORVIUM BIOSCIENCE and a shift in market share towards other antifungal treatments.

What are some alternative antifungal treatments available?

Other OTC antifungal drugs like clotrimazole, econazole, and miconazole, as well as new product launches like Supra Bioavailable Itraconazole capsules, are available alternatives.

How does the discontinuation of EXTINA affect consumer safety?

Patients need to be cautious when purchasing alternative medications online to avoid counterfeit products, which can be potentially unsafe.

Sources

1. Mordor Intelligence: Antifungal Drugs Market Size & Share Analysis - Growth Trends
2. AstraZeneca: Q1 2024 results announcement
3. Express Scripts Canada: 2013 Drug Trend Report
4. Drugs.com: Generic Extina Availability