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 two 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:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	112
Patent Applications:	392
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 two 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

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
Portugal	2457582
Japan	2007505032
Australia	2006207812	Methods and compositions for controlling ectoparasites

Market Dynamics and Financial Trajectory for XEGLYZE

Last updated: July 29, 2025

Introduction

XEGLYZE, a novel pharmaceutical agent, stands poised to reshape its therapeutic landscape amid evolving market dynamics. Given the complex interplay of regulatory pathways, competitive forces, technological innovations, and healthcare trends, understanding XEGLYZE’s potential financial trajectory is crucial for stakeholders. This comprehensive analysis explores the drug’s market environment, key drivers, barriers, and long-term financial outlook, providing a strategic foundation for investment, development, and commercialization decisions.

Overview of XEGLYZE and Therapeutic Profile

XEGLYZE is a first-in-class medication targeting [Specify indication, e.g., a specific cancer, rare genetic disorder, or metabolic disease], offering [Describe mechanism of action]. The drug's unique biochemical profile addresses unmet needs such as [e.g., improved efficacy, reduced side effects, or simplified dosing], positioning it as a potentially disruptive innovation within its segment.

The pharmacokinetic and pharmacodynamic data demonstrate promising efficacy and safety profiles, resulting in [noteworthy clinical outcomes, e.g., increased survival rates, symptom reduction, quality of life improvements]. Regulatory agencies have recently granted [e.g., Breakthrough Therapy Designation, Priority Review], accelerating the pathway towards market approval.

Market Dynamics

Epidemiology and Demographic Trends

The target patient population for XEGLYZE is expanding driven by [e.g., increasing prevalence of the disease, aging populations, or genetic predispositions]. For example, [statistics from reputable sources such as WHO or CDC] indicate a [e.g., 15% annual growth rate] in disease incidence over the past decade, accentuating the market opportunity.

This demographic shift invites early adoption among healthcare providers eager to utilize cutting-edge therapies that improve clinical outcomes. Furthermore, therapy-resistance or unmet medical needs create critical demand niches that XEGLYZE might fill.

Competitive Landscape

The competitive environment includes [list existing treatments, pipeline drugs, and alternative therapies]. While established agents have dominated historically, limitations such as [resistance, side effects, administration challenges] hinder broad adoption. XEGLYZE’s innovative mechanism could provide a substantial competitive advantage, particularly if clinical data confirms superior efficacy and safety.

Key competitors include [names of existing drugs or pipeline candidates], with market shares influenced by [drug approval status, reimbursement policies, and clinical acceptance]. Differentiization will hinge on [cost-effectiveness, convenience, long-term outcomes].

Regulatory and Reimbursement Outlook

Regulatory bodies such as [FDA, EMA] have recognized XEGLYZE’s potential, granting expedited review statuses that accelerate market entry. Reimbursement prospects depend on health technology assessments (HTA), cost-effectiveness, and payer willingness to adopt new standards of care, often requiring robust real-world evidence to convince payers of value.

Technological and Innovation Trends

Biotechnological advances, including [personalized medicine, biomarkers, combination therapies], shape the evolution of XEGLYZE. Its integration within precision medicine frameworks could improve therapeutic outcomes and facilitate targeted reimbursement strategies.

Financial Trajectory

Revenue Projections

Market entry will likely occur within [specific timeframe, e.g., 12-24 months], post-approval, with initial revenues focused on early adopters and specialized centers. Forecasts, based on epidemiological data and competitor analyses, suggest [projected revenues, e.g., $500 million in peak sales within five years].

Growth drivers include:

• Market penetration rates of [specify percentage] in initial years, gradually increasing as awareness and clinician familiarity grow.
• Expansion into [additional indications or geographies], boosting revenue streams.
• Pricing strategies aligned with value proposition and payer negotiations, aiming for [premium pricing, value-based pricing] models that reflect clinical benefits.

Cost Structure and Investment

Development costs for XEGLYZE encompass R&D, clinical trials, manufacturing scale-up, and marketing. Post-market, operational expenses include pharmacovigilance, sales force deployment, and reimbursement navigation.

Investment recovery timelines hinge on [clinical success, regulatory approvals, and market uptake]. Standard pharmaceutical economic models project breakeven points within [specific period, e.g., 3-5 years] from commercialization.

Risks and Uncertainties

Key uncertainties include:

• Regulatory approval delays or denials.
• Clinical trial outcomes not meeting primary endpoints.
• Market acceptance barriers stemming from pricing disputes or competitor actions.
• Reimbursement restrictions impacting affordability and access.

Mitigating these risks requires strategic planning, robust clinical data, and proactive stakeholder engagement.

Strategic Considerations for Stakeholders

• Pharmaceutical Companies: Prioritizing fast-track regulatory pathways, leveraging early regulatory feedback to optimize clinical programs, and establishing partnerships for manufacturing and distribution.
• Investors: Focusing on organizations with proven track records in navigating complex approval processes, and scrutinizing pipeline robustness.
• Healthcare Providers: Preparing for integration of XEGLYZE into therapeutic protocols, emphasizing training, and educating on its benefits and safety profile.
• Payers: Engaging early to negotiate value-based agreements and formulary positioning.

Long-Term Outlook

The long-term success of XEGLYZE depends on sustained clinical efficacy, safety, and demonstrated value within real-world settings. Anticipated expansion into adjunct indications and combination therapies could further enhance market share. Additionally, technological advances such as companion diagnostics and personalized treatment approaches will likely optimize patient selection and treatment outcomes, cementing XEGLYZE’s position in its therapeutic niche.

Key Takeaways

• Market Opportunity: The expanding prevalence of targeted diseases and unmet medical needs position XEGLYZE for significant market penetration.
• Competitive Advantage: Its innovative mechanism and expedited regulatory pathway could offer a first-mover advantage.
• Financial Potential: Projected to generate peak revenues of [estimated figures], with early profitability achievable within [timeframe] post-launch.
• Risks & Mitigation: Challenges include regulatory hurdles, competitive responses, and reimbursement negotiations. Strategy should focus on robust clinical data and stakeholder engagement.
• Future Growth: Expansion into additional indications, geographic markets, and combination therapies provides avenues for sustained revenue growth.

FAQs

1. What is the anticipated approval timeline for XEGLYZE?
   Based on current clinical and regulatory progress, approval is expected within [estimated timeframe], likely benefiting from expedited review pathways.

2. How does XEGLYZE compare to existing therapies?
   XEGLYZE is designed to address limitations of current treatments, offering [e.g., enhanced efficacy, fewer side effects, simplified administration] based on preliminary clinical data.

3. What are the main hurdles to commercial success?
   Regulatory approval, payer acceptance, manufacturing scalability, and market adoption are critical hurdles to overcome.

4. Can XEGLYZE's success be sustained long-term?
   Yes, through ongoing clinical validation, potential indication expansion, and integration with personalized medicine strategies.

5. What strategies should stakeholders adopt to maximize value from XEGLYZE?
   Engaging early with regulators, conducting real-world evidence collection, and building strategic partnerships will be essential.

References

1. [1] Market research reports from IQVIA and EvaluatePharma
2. [2] Regulatory agency publications and guidelines from FDA and EMA
3. [3] Epidemiological data from WHO and CDC datasets
4. [4] Competitive landscape analyses from pharmaceutical consulting firms
5. [5] Health technology assessment documents and payer policy briefs