Zileuton - Generic Drug Details

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

Zileuton is the generic ingredient in three branded drugs marketed by Aizant, Annora Pharma, Lupin Ltd, Rising, Strides Pharma, Teva Pharms Usa, and Chiesi, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for zileuton. Six suppliers are listed for this compound.

Summary for zileuton

US Patents:	0
Tradenames:	3
Applicants:	7
NDAs:	8
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	131
Clinical Trials:	21
Patent Applications:	5,987
Drug Prices:	Drug price trends for zileuton
What excipients (inactive ingredients) are in zileuton?	zileuton excipients list
DailyMed Link:	zileuton at DailyMed

See drug prices for zileuton

Recent Clinical Trials for zileuton

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

Sponsor	Phase
Postgraduate Institute of Dental Sciences Rohtak	Phase 4
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4

See all zileuton clinical trials

Pharmacology for zileuton

Drug Class	5-Lipoxygenase Inhibitor
Mechanism of Action	5-Lipoxygenase Inhibitors
Physiological Effect	Decreased Leukotriene Production

US Patents and Regulatory Information for zileuton

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Usa	ZILEUTON	zileuton	TABLET, EXTENDED RELEASE;ORAL	211043-001	May 3, 2022		DISCN	No	No
Annora Pharma	ZILEUTON	zileuton	TABLET, EXTENDED RELEASE;ORAL	215742-001	Oct 11, 2022	AB	RX	No	No
Lupin Ltd	ZILEUTON	zileuton	TABLET, EXTENDED RELEASE;ORAL	211972-001	Nov 5, 2019		DISCN	No	No
Aizant	ZILEUTON	zileuton	TABLET, EXTENDED RELEASE;ORAL	211390-001	Oct 23, 2020	AB	RX	No	No
Strides Pharma	ZILEUTON	zileuton	TABLET, EXTENDED RELEASE;ORAL	212670-001	Dec 16, 2019	AB	RX	No	No
Chiesi	ZYFLO CR	zileuton	TABLET, EXTENDED RELEASE;ORAL	022052-001	May 30, 2007		DISCN	Yes	No
Chiesi	ZYFLO	zileuton	TABLET;ORAL	020471-001	Dec 9, 1996		DISCN	No	No

Expired US Patents for zileuton

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	ZYFLO CR	zileuton	TABLET, EXTENDED RELEASE;ORAL	022052-001	May 30, 2007
Chiesi	ZYFLO	zileuton	TABLET;ORAL	020471-003	Dec 9, 1996
Chiesi	ZYFLO	zileuton	TABLET;ORAL	020471-001	Dec 9, 1996
Chiesi	ZYFLO CR	zileuton	TABLET, EXTENDED RELEASE;ORAL	022052-001	May 30, 2007
Chiesi	ZYFLO CR	zileuton	TABLET, EXTENDED RELEASE;ORAL	022052-001	May 30, 2007

Zileuton Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zileuton

Introduction to Zileuton

Zileuton is a leukotriene synthesis inhibitor used primarily in the treatment of asthma and other respiratory conditions. It works by blocking the production of leukotrienes, which are inflammatory chemicals that can cause airway constriction and increased mucus production.

Market Size and Growth Projections

The global Zileuton market has been experiencing significant growth in recent years. According to market research, the Zileuton market is projected to continue its upward trajectory from 2023 to 2031. The market size is expected to expand substantially, driven by increasing demand for effective treatments for respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD)[1][4].

Market Segmentation

The Zileuton market is segmented based on several key factors:

By Type

• Tablets: This segment includes the traditional tablet form of zileuton.
• Extended Release: This segment includes formulations designed for slower release, providing longer-lasting effects.
• Oral: This encompasses other oral forms of the drug, including chewable tablets and oral granules[1][4].

By Application

• Hospital: Zileuton is often prescribed and administered in hospital settings.
• Drug Store: The drug is also available through retail pharmacies and drug stores, which are increasingly preferred by patients due to convenience[1][3].

By Geography

The market is analyzed across various geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America is expected to generate the most revenue due to the high incidence of respiratory diseases in this region[1][3].

Drivers of the Market

Several factors are driving the growth of the Zileuton market:

Increasing Prevalence of Respiratory Diseases

The rise in asthma and COPD cases globally, particularly in regions with high pollution levels and changing environmental conditions, is a significant driver. Allergic diseases, which affect approximately 35% of the global population, also contribute to the demand for leukotriene modifiers like zileuton[3].

Improvements in Healthcare Infrastructure

The availability of well-established healthcare facilities and advancements in treatment options are boosting the market. In developed countries, the prevalence of allergies and respiratory diseases is higher, further driving the demand for zileuton[3].

Convenience of Retail Pharmacies

Retail pharmacies are becoming more popular for purchasing medications due to their convenience, which is another factor contributing to the market growth[3].

Financial Performance

Historically, zileuton has shown strong financial performance. For instance, in the second quarter of 2013, net sales of the ZYFLO® (zileuton) family of products increased by 37% compared to the same period in 2012, reaching $14.8 million. This period also saw a significant improvement in net income, from a loss of $4.4 million in 2012 to a net income of $5.8 million in 2013[2].

Revenue Projections

The market is expected to continue its strong financial trajectory. With a projected CAGR, the revenue from zileuton sales is anticipated to increase substantially over the forecast period from 2023 to 2031. The detailed market analysis includes predictions for revenue growth, which will be driven by the increasing demand for effective treatments for respiratory diseases[1][4].

Competitive Landscape

The Zileuton market is competitive, with several key players:

• Prasco
• Chiesi
• Lupin
• Endo International
• Rising

These companies are profiled based on their product portfolios, financial statements, key developments, and strategic market approaches. The competitive landscape also includes an analysis of mergers and acquisitions, product launches, and other pivotal developments[1].

Market Outlook

The market outlook for zileuton is positive, driven by several growth catalysts:

Porter's 5 Forces Framework

This framework analysis reveals that the market is influenced by factors such as the bargaining power of buyers, the threat of new entrants, the threat of substitute products, the bargaining power of suppliers, and the intensity of competitive rivalry[1].

Macroeconomic Scrutiny

Macroeconomic factors, including economic growth, healthcare policies, and demographic changes, are also scrutinized to understand their impact on the market[1].

Value Chain Evaluation

The value chain analysis highlights the efficiency and effectiveness of the supply chain, from production to distribution, which is crucial for maintaining market competitiveness[1].

Challenges and Opportunities

Despite the positive outlook, the market faces several challenges and opportunities:

Challenges

• Regulatory Hurdles: Strict regulatory environments can pose challenges for new product approvals and market entry.
• Competition: The presence of other leukotriene modifiers and generic alternatives can compete with zileuton for market share[1][3].

Opportunities

• Emerging Markets: Growing healthcare needs in developing countries present opportunities for market expansion.
• Innovative Formulations: Developing new formulations, such as extended-release versions, can enhance patient compliance and market penetration[1][4].

Key Takeaways

• The Zileuton market is expected to grow significantly from 2023 to 2031, driven by increasing demand for respiratory disease treatments.
• The market is segmented by type, application, and geography, with North America being a key revenue generator.
• Drivers include the rising prevalence of respiratory diseases, improvements in healthcare infrastructure, and the convenience of retail pharmacies.
• Financial performance is strong, with historical data showing significant revenue growth.
• The competitive landscape is dominated by several key players, and the market outlook is positive despite some challenges.

FAQs

What is the primary use of zileuton?

Zileuton is primarily used in the treatment of asthma and other respiratory conditions by inhibiting the production of leukotrienes.

Which region is expected to dominate the zileuton market?

North America is expected to generate the most revenue in the zileuton market due to the high incidence of respiratory diseases in this region.

What are the key drivers of the zileuton market?

Key drivers include the increasing prevalence of respiratory diseases, improvements in healthcare infrastructure, and the convenience of retail pharmacies.

Who are the major players in the zileuton market?

Major players include Prasco, Chiesi, Lupin, Endo International, and Rising.

What are the challenges faced by the zileuton market?

Challenges include regulatory hurdles, competition from other leukotriene modifiers and generic alternatives, and the need for innovative formulations to enhance market penetration.

Sources

1. Market Research Intellect: Global Zileuton Market Size, Scope And Forecast Report.
2. GlobeNewswire: Cornerstone Therapeutics Reports Second Quarter 2013 Financial Results.
3. Future Market Insights: Leukotriene Modifiers Market - Share, Size & Forecast 2033.
4. Cognitive Market Research: Global Zileuton Market Report 2024 Edition.