XEGLYZE Drug Patent Profile

When do Xeglyze patents expire, and what generic alternatives are available?

Xeglyze is a drug marketed by Hatchtech and is included in one NDA. There are five patents protecting this drug.

This drug has thirty-six patent family members in fifteen countries.

The generic ingredient in XEGLYZE is abametapir. One supplier is listed for this compound. Additional details are available on the abametapir profile page.

DrugPatentWatch^® Generic Entry Outlook for Xeglyze

Xeglyze was eligible for patent challenges on July 31, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 17, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for XEGLYZE

International Patents:	36
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	112
Patent Applications:	283
What excipients (inactive ingredients) are in XEGLYZE?	XEGLYZE excipients list
DailyMed Link:	XEGLYZE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for XEGLYZE

Constraining patent/regulatory exclusivity:

10,292,389

NDA:

206966

Dosage:

LOTION;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for XEGLYZE

XEGLYZE is protected by five US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 10,292,389.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hatchtech	XEGLYZE	abametapir	LOTION;TOPICAL	206966-001	Jul 24, 2020		DISCN	Yes	No	7,812,163		Y
Hatchtech	XEGLYZE	abametapir	LOTION;TOPICAL	206966-001	Jul 24, 2020		DISCN	Yes	No	10,292,389		Y
Hatchtech	XEGLYZE	abametapir	LOTION;TOPICAL	206966-001	Jul 24, 2020		DISCN	Yes	No	9,839,631		Y	Y
Hatchtech	XEGLYZE	abametapir	LOTION;TOPICAL	206966-001	Jul 24, 2020		DISCN	Yes	No	8,212,038		Y
Hatchtech	XEGLYZE	abametapir	LOTION;TOPICAL	206966-001	Jul 24, 2020		DISCN	Yes	No
Hatchtech	XEGLYZE	abametapir	LOTION;TOPICAL	206966-001	Jul 24, 2020		DISCN	Yes	No	9,357,783		Y

Expired US Patents for XEGLYZE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hatchtech	XEGLYZE	abametapir	LOTION;TOPICAL	206966-001	Jul 24, 2020	8,212,038
Hatchtech	XEGLYZE	abametapir	LOTION;TOPICAL	206966-001	Jul 24, 2020	9,839,631
Hatchtech	XEGLYZE	abametapir	LOTION;TOPICAL	206966-001	Jul 24, 2020	9,357,783

International Patents for XEGLYZE

When does loss-of-exclusivity occur for XEGLYZE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

Eurasian Patent Organization

European Patent Office

Japan

New Zealand

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XEGLYZE around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2015107384
Canada	2532789	METHODES ET COMPOSITIONS DE LUTTE CONTRE LES ECTOPARASITES (METHODS AND COMPOSITIONS FOR CONTROLLING ECTOPARASITES)
New Zealand	720995	Pediculicidal composition
World Intellectual Property Organization (WIPO)	2005007188
China	101810613	Prevention and cure method for ectoparasite and compounds thereof
Australia	2006207812	Methods and compositions for controlling ectoparasites

XEGLYZE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Xeglyze

Introduction to Xeglyze

Xeglyze, a drug approved by the U.S. FDA in July 2020, is specifically designed to treat head lice in patients six months of age and older. This approval marked a significant milestone in the lice treatment market, contributing to its growth and dynamics.

FDA Approval and Clinical Efficacy

The FDA approval of Xeglyze was based on a clinical trial that demonstrated the drug's efficacy in preventing head lice infestations. The trial showed that approximately 80% of patients treated with Xeglyze were free of live head lice, highlighting the drug's effectiveness[1][4].

Market Impact

Market Growth

The approval of Xeglyze has been a key factor in the growth of the lice treatment market. The market is expected to reach USD 1.10 billion in 2024 and grow at a CAGR of 6.66% to reach USD 1.53 billion by 2029. This growth is partly attributed to the increasing demand for effective lice treatment options, which Xeglyze has helped to fulfill[1].

Regional Dynamics

The lice treatment market, including Xeglyze, is seeing significant growth in various regions. North America currently holds the largest market share, while the Asia Pacific region is expected to be the fastest-growing market over the forecast period. This regional growth indicates a broader acceptance and demand for Xeglyze and other lice treatment products[1].

Financial Trajectory

Revenue Contribution

The introduction of Xeglyze has contributed to the revenue growth of companies operating in the lice treatment market. For instance, Dr. Reddy's Laboratories, which might be involved in the distribution or manufacturing of such drugs, has seen an increase in their revenues over the years. Although specific financial data for Xeglyze is not detailed, the overall revenue growth in the lice treatment market suggests a positive financial trajectory for drugs like Xeglyze[5].

Legal and Financial Implications

There have been legal and financial implications associated with Xeglyze. For example, Dr. Reddy's Laboratories faced an arbitration ruling in favor of Hatchtech Pty Limited, the developer of Xeglyze, resulting in a provision for potential liability of U.S.$20 million and an eventual recognition of U.S.$26.25 million in their financial statements. This highlights the complex financial landscape surrounding the drug's development and distribution[5].

Market Trends and Drivers

Increasing Product Approvals

The approval of Xeglyze is part of a broader trend of increasing product approvals in the lice treatment market. Such approvals enhance the market's growth by providing more effective treatment options, thereby increasing consumer confidence and demand[1][4].

COVID-19 Pandemic Impact

The COVID-19 pandemic has had a significant impact on the lice treatment market. There was an increase in the dispensing of ivermectin and other treatments during the pandemic, indicating a heightened need for lice treatment solutions. This increased demand has contributed to the market's growth and the financial trajectory of drugs like Xeglyze[1].

Competitive Landscape

Key Players

The lice treatment market, including Xeglyze, is dominated by several key players such as Alliance Pharmaceuticals Ltd., Prestige Consumer Healthcare Inc., GlaxoSmithKline plc, Oystershell Consumer Health, Inc., and Perrigo Company plc. These companies play a crucial role in the development, distribution, and marketing of lice treatment products, influencing the market dynamics and financial performance of drugs like Xeglyze[1].

Consumer Demand and Preferences

Growing Need for Effective Treatments

The growing need for effective and safe lice treatment options drives the demand for drugs like Xeglyze. Parents and caregivers are increasingly seeking treatments that are both efficacious and safe for children, which Xeglyze's FDA approval and clinical efficacy have addressed[1].

Regulatory Environment

FDA Approvals and Compliance

The regulatory environment, particularly FDA approvals, plays a critical role in the market dynamics and financial trajectory of Xeglyze. The FDA's stringent approval process ensures that only safe and effective treatments are brought to the market, which can impact the financial performance and market acceptance of drugs like Xeglyze[1][4].

Future Outlook

Market Projections

The lice treatment market, driven by products like Xeglyze, is expected to continue its growth trajectory. With a projected CAGR of 6.66% from 2024 to 2029, the market is poised to reach USD 1.53 billion by 2029. This growth will likely be fueled by ongoing product approvals, increasing demand, and the expanding reach of effective lice treatment options[1].

Key Takeaways

• FDA Approval: Xeglyze was approved by the FDA in July 2020, demonstrating 80% efficacy in treating head lice.
• Market Growth: The lice treatment market is expected to grow from USD 1.10 billion in 2024 to USD 1.53 billion by 2029.
• Regional Dynamics: North America holds the largest market share, while the Asia Pacific region is the fastest-growing.
• Financial Trajectory: The drug has contributed to revenue growth, despite legal and financial complexities.
• Market Trends: Increasing product approvals and the COVID-19 pandemic have driven market growth.
• Competitive Landscape: Key players include Alliance Pharmaceuticals Ltd., Prestige Consumer Healthcare Inc., and others.

FAQs

What is Xeglyze and how is it used?

Xeglyze is a drug approved by the FDA to treat head lice in patients six months of age and older.

What was the impact of the COVID-19 pandemic on the lice treatment market?

The COVID-19 pandemic led to an increase in the dispensing of lice treatments, including a surge in ivermectin prescriptions and increased patient visits to lice clinics.

Who are the key players in the lice treatment market?

Key players include Alliance Pharmaceuticals Ltd., Prestige Consumer Healthcare Inc., GlaxoSmithKline plc, Oystershell Consumer Health, Inc., and Perrigo Company plc.

What is the projected market size for the lice treatment market by 2029?

The lice treatment market is expected to reach USD 1.53 billion by 2029.

What is the significance of FDA approval for Xeglyze?

The FDA approval of Xeglyze ensures that the drug meets stringent safety and efficacy standards, which is crucial for market acceptance and consumer trust.

Sources

1. Mordor Intelligence: Lice Treatment Market - Analysis, Size & Trends.
2. Annual Reports: Dr. Reddy's Laboratories Annual Report 2021.
3. Pharmaceuticals.gov.in: An Analysis on leveraging the patent cliff with drug sales worth USD 251 billion.
4. Mordor Intelligence: Lice Treatment Market Trends.
5. Dr. Reddy's Laboratories: United States - Dr. Reddy's Laboratories.