ZYFLO Drug Patent Profile

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

Zyflo is a drug marketed by Chiesi and is included in two NDAs.

The generic ingredient in ZYFLO is zileuton. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the zileuton profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zyflo

A generic version of ZYFLO was approved as zileuton by RISING on March 17^th, 2017.

Summary for ZYFLO

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	130
Drug Prices:	Drug price information for ZYFLO
What excipients (inactive ingredients) are in ZYFLO?	ZYFLO excipients list
DailyMed Link:	ZYFLO at DailyMed

See drug prices for ZYFLO

Pharmacology for ZYFLO

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

US Patents and Regulatory Information for ZYFLO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chiesi	ZYFLO	zileuton	TABLET;ORAL	020471-001	Dec 9, 1996		DISCN	No	No
Chiesi	ZYFLO	zileuton	TABLET;ORAL	020471-003	Dec 9, 1996		RX	Yes	Yes
Chiesi	ZYFLO CR	zileuton	TABLET, EXTENDED RELEASE;ORAL	022052-001	May 30, 2007		DISCN	Yes	No

Expired US Patents for ZYFLO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	ZYFLO	zileuton	TABLET;ORAL	020471-001	Dec 9, 1996
Chiesi	ZYFLO	zileuton	TABLET;ORAL	020471-003	Dec 9, 1996

International Patents for ZYFLO

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

Country	Patent Number	Title	Estimated Expiration
Australia	6220190
European Patent Office	0279263	INDOLE, BENZOFURAN, BENZOTHIOPHENE CONTAINING LIPOXYGENASE INHIBITING COMPOUNDS
Japan	H03148272	LIPOXYGENASE CONTROL COMPOUND
Mexico	9202874	COMPUESTOS INHIBIDORES DE LIPOXIGENASA QUE CONTIENEN INDOL BENXOFURANO BENZOTIOFENO.
Portugal	95231	PROCESSO DE PREPARACAO DE INIBIDORES DA LIPOXIGENASE CONTENDO INDOLO,BENZOFURANO E BENZOTIOFENO E DE COMPOSICOES FARMACEUTICAS
Spain	2099079

Market Dynamics and Financial Trajectory for ZYFLO (Zileuton)

Understanding Zileuton

Zileuton, marketed under the brand name ZYFLO, is a 5-lipoxygenase inhibitor that plays a crucial role in managing asthma and other inflammatory conditions by disrupting the synthesis of leukotrienes. These leukotrienes are key contributors to inflammation and bronchoconstriction, making Zileuton an effective treatment for respiratory ailments[1].

Market Size and Share

The global Zileuton market is part of the broader leukotriene modifiers market, which was valued at approximately $21.9 billion in 2022. This market is projected to grow at a CAGR of 5.3% from 2023 to 2033, reaching a valuation of $38.65 billion by 2033[4].

Geographical Distribution

Geographically, the Zileuton market is dominated by North America and Europe, primarily due to the high prevalence of respiratory disorders and the presence of robust pharmaceutical industries in these regions. However, emerging economies in the Asia-Pacific region present significant growth opportunities driven by increasing healthcare expenditure and rising awareness about respiratory health[1].

Market Drivers

Several factors drive the growth of the Zileuton market:

• Increasing Prevalence of Respiratory Diseases: The global rise in asthma and chronic obstructive pulmonary disease (COPD) cases is a major driver. Environmental changes, such as increased pollution levels and changing climatic conditions, also contribute to the growing need for respiratory medications[4].
• Aging Population: An aging population increases the demand for effective respiratory treatments, as older individuals are more susceptible to respiratory diseases.
• Improvements in Healthcare Infrastructure: The availability of well-established healthcare facilities and advancements in treatment options further boost the market[4].

Market Challenges

Despite the growth potential, the Zileuton market faces several challenges:

• Regulatory Frameworks: Variations in regulatory frameworks across different regions can impact market dynamics. For instance, stringent regulatory requirements can slow down the approval process for new formulations[1].
• Competition: The presence of other leukotriene modifiers, such as montelukast, can pose competition. Montelukast is expected to have a major share in the leukotriene modifiers market due to its widespread use in treating asthma and allergies[4].

Financial Performance

Historically, companies associated with Zileuton have faced financial challenges. For example, Critical Therapeutics, the maker of ZYFLO, reported a net loss of $8.0 million in the second quarter of 2004 and a net loss of $9.1 million in the first quarter of 2005[2][5].

Future Prospects

Despite past financial setbacks, the future outlook for Zileuton is promising:

• Growing Demand: The increasing demand for effective respiratory medications, coupled with ongoing research into novel formulations and expanded therapeutic indications, is expected to fuel market growth[1].
• Expanding Therapeutic Indications: Research aimed at exploring new uses for Zileuton, such as treating other inflammatory conditions, could further expand its market potential.
• Emerging Markets: The Asia-Pacific region, with its growing healthcare expenditure and increasing awareness of respiratory health, offers significant opportunities for market expansion[1].

Distribution Channels

Hospital pharmacies are the most profitable segment in the leukotriene modifiers market, including Zileuton. This is due to the high volume of prescriptions filled through these channels for chronic conditions like asthma[4].

Product Variations

Zileuton is available in different formulations, including immediate-release and extended-release (ER) versions. These variations cater to different patient needs and preferences, enhancing the drug's market appeal[4].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the pharmaceutical industry, including the Zileuton market. While it has accelerated the need for respiratory treatments, it has also posed challenges in terms of supply chain disruptions and changes in healthcare priorities[1].

Key Takeaways

• Market Growth: The Zileuton market is expected to grow, driven by increasing respiratory disease prevalence and improvements in healthcare infrastructure.
• Geographical Dominance: North America and Europe currently dominate the market, but the Asia-Pacific region offers significant growth opportunities.
• Financial Challenges: Historical financial losses by companies associated with Zileuton highlight the need for strategic market positioning and cost management.
• Future Prospects: Ongoing research and expanding therapeutic indications are expected to fuel future growth.

FAQs

What is Zileuton used for?

Zileuton is used to treat asthma and other inflammatory conditions by inhibiting the synthesis of leukotrienes, which are involved in inflammation and bronchoconstriction.

Which regions dominate the Zileuton market?

North America and Europe currently dominate the Zileuton market due to the high prevalence of respiratory diseases and robust pharmaceutical industries.

What are the key drivers of the Zileuton market?

Key drivers include the increasing prevalence of respiratory diseases, aging populations, and improvements in healthcare infrastructure.

How has the COVID-19 pandemic affected the Zileuton market?

The pandemic has accelerated the need for respiratory treatments but also posed challenges such as supply chain disruptions and changes in healthcare priorities.

What are the future prospects for the Zileuton market?

The market is expected to grow, driven by ongoing research into novel formulations and expanded therapeutic indications, as well as increasing demand in emerging markets.

Sources

1. Exploring the Global Zileuton Market: Trends, Analysis, and COVID-19 Impact Forecast (2024-2031) - openPR.com
2. Zyflo Filmtab maker reports Q2 loss of $8.0 million - Gale
3. Weighing the GLP-1 market - Goldman Sachs
4. Leukotriene Modifiers Market - Share, Size & Forecast 2033 - Future Market Insights
5. ZYFLO maker reports Q1 net loss of $9.1 million - Gale