VERSACLOZ Drug Patent Profile

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

Versacloz is a drug marketed by Tasman Pharma and is included in one NDA. There is one patent protecting this drug.

This drug has six patent family members in six countries.

The generic ingredient in VERSACLOZ is clozapine. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the clozapine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Versacloz

A generic version of VERSACLOZ was approved as clozapine by IVAX SUB TEVA PHARMS on November 26^th, 1997.

Summary for VERSACLOZ

International Patents:	6
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	131
Patent Applications:	5,220
What excipients (inactive ingredients) are in VERSACLOZ?	VERSACLOZ excipients list
DailyMed Link:	VERSACLOZ at DailyMed

Pharmacology for VERSACLOZ

Drug Class

Atypical Antipsychotic

US Patents and Regulatory Information for VERSACLOZ

VERSACLOZ is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tasman Pharma	VERSACLOZ	clozapine	SUSPENSION;ORAL	203479-001	Feb 6, 2013		RX	Yes	Yes	8,057,811		Y

International Patents for VERSACLOZ

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

Country	Patent Number	Title	Estimated Expiration
Canada	2532648	FORMULATION DE SUSPENSION STABLE DE CLOZAPINE (A STABLE CLOZAPINE SUSPENSION FORMULATION)
Australia	2004257556	A stable clozapine suspension formulation
Spain	2436213
European Patent Office	1646393	FORMULATION DE SUSPENSION STABLE DE CLOZAPINE (A STABLE CLOZAPINE SUSPENSION FORMULATION)
World Intellectual Property Organization (WIPO)	2005007168
New Zealand	527142	A stable suspension formulation

VERSACLOZ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VERSACLOZ

Introduction to VERSACLOZ

VERSACLOZ, a brand name for the oral suspension formulation of clozapine, is an atypical antipsychotic medication primarily used to treat treatment-resistant schizophrenia and reduce the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder. Here, we delve into the market dynamics and financial trajectory of VERSACLOZ.

Market Segmentation and Indications

VERSACLOZ is indicated for two main purposes:

• Treatment-resistant schizophrenia: For severely ill patients who have failed to respond adequately to standard antipsychotic treatments[4][5].
• Reduction in recurrent suicidal behavior: For patients with schizophrenia or schizoaffective disorder who are at chronic risk of re-experiencing suicidal behavior[4][5].

The market can be segmented based on indication, form, and end-user. The primary indications include schizophrenia, unipolar depression, bipolar disorder, and dementia, among others. The drug is available in both tablet and liquid forms, catering to different patient needs[1].

Key Drivers of the Market

Rising Cases of Schizophrenia and Related Disorders

The increasing prevalence of schizophrenia and other related mental health disorders is a significant driver of the VERSACLOZ market. Genetic mutations, physical illnesses, and substance-induced psychoses contribute to the rising cases of these disorders, thereby boosting the demand for effective treatments like VERSACLOZ[1].

Research and Development Investments

Significant investments in research and development activities, including the introduction of novel clozapine moieties, are fueling the growth of the market. These investments aim to expand the therapeutic applications of clozapine, offering new treatment options for patients[1].

Increasing Initiatives by Market Players

Key market players, such as Jazz Pharmaceuticals, are expanding their efforts to enhance the availability and accessibility of VERSACLOZ. This includes providing blood monitoring and reporting support services, which are not typically offered by generic clozapine manufacturers[4].

Regional Market Performance

North America

North America is projected to capture a major share of the global clozapine market, driven by the high prevalence of mental health disorders in the region. In the U.S., for instance, approximately 6.7% of the population aged 18 and above suffered from depression in 2016, contributing to the demand for VERSACLOZ[1].

Asia Pacific

The Asia Pacific region is anticipated to be the second-largest market for VERSACLOZ. Increasing social awareness about mental health issues, growing healthcare infrastructure, and government investments in mental health services are driving the market growth in this region[1].

Financial Trajectory

Revenue and Market Size

The global clozapine market, which includes VERSACLOZ, is expected to grow significantly due to the increasing demand for effective treatments for schizophrenia and other mental health disorders. The market size is determined by combining top-down and bottom-up approaches, using financial reports, key market indicators, and data from healthcare spending per capita[3].

Cost and Pricing

The financial trajectory of VERSACLOZ is influenced by its pricing strategy and the costs associated with its use. The drug is often covered under various healthcare plans, including Medicaid and Medicare, which can impact its revenue. Additionally, the costs of monitoring and managing side effects, such as agranulocytosis and seizures, can also affect the overall financial performance[2][5].

Reimbursement and Insurance Coverage

Reimbursement policies play a crucial role in the financial trajectory of VERSACLOZ. The drug is often included in mental health carve-out programs, which can influence its adoption and revenue. For example, in Oregon, mental health carve-out drugs, including antipsychotics like clozapine, account for a significant portion of the total drug costs[2].

Challenges and Restraints

Side Effects and Safety Concerns

Despite its efficacy, VERSACLOZ is associated with several side effects, including agranulocytosis, seizures, QT interval prolongation, and metabolic changes. These safety concerns can restrain the market growth as they may lead to reduced patient compliance and increased healthcare costs[5].

Regulatory Requirements

The use of VERSACLOZ is subject to strict regulatory requirements, including regular blood monitoring to mitigate the risk of agranulocytosis. This can add to the overall cost and complexity of treatment, potentially affecting the financial performance of the drug[4][5].

Future Outlook

Growing Demand for Mental Health Treatments

The increasing awareness and emphasis on mental health, particularly in regions like Saudi Arabia, are expected to drive the demand for treatments like VERSACLOZ. The market is anticipated to grow as customers seek innovative and personalized solutions for psychotic disorders[3].

Holistic Treatment Approaches

The trend towards holistic approaches to treating psychotic disorders, including medication management, therapy, and lifestyle changes, is likely to boost the market for VERSACLOZ. This multidimensional approach recognizes the need to address both symptoms and underlying causes, which aligns with the comprehensive treatment profile of VERSACLOZ[3].

Key Takeaways

• Rising Prevalence of Mental Health Disorders: Increasing cases of schizophrenia and related disorders drive the demand for VERSACLOZ.
• Research and Development: Investments in R&D and the introduction of novel clozapine moieties are key drivers of market growth.
• Regional Performance: North America and Asia Pacific are significant markets due to high prevalence rates and growing healthcare infrastructure.
• Financial Trajectory: The market is influenced by revenue, cost, pricing, and reimbursement policies.
• Challenges: Side effects and safety concerns, along with regulatory requirements, are restraints to market growth.
• Future Outlook: Growing demand for mental health treatments and holistic treatment approaches are expected to drive the market forward.

FAQs

What is VERSACLOZ used for?

VERSACLOZ is used for the treatment of treatment-resistant schizophrenia and the reduction of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder[4][5].

What are the key drivers of the VERSACLOZ market?

The key drivers include rising cases of schizophrenia and related disorders, investments in research and development, and increasing initiatives by market players[1].

What regions are expected to dominate the VERSACLOZ market?

North America and the Asia Pacific region are projected to be the major markets for VERSACLOZ due to high prevalence rates and growing healthcare infrastructure[1].

What are the significant side effects associated with VERSACLOZ?

Significant side effects include agranulocytosis, seizures, QT interval prolongation, and metabolic changes[5].

How does regulatory oversight impact the use of VERSACLOZ?

Regulatory requirements, such as regular blood monitoring, add to the complexity and cost of treatment, potentially affecting patient compliance and market growth[4][5].

What is the future outlook for the VERSACLOZ market?

The market is expected to grow due to increasing demand for mental health treatments and a shift towards holistic treatment approaches[3].

Sources

1. BioSpace: Clozapine Market: Rising cases of Schizophrenia and its related disorders to drive the market.
2. Oregon Drug Use Review / Pharmacy & Therapeutics Committee: Pharmacy Utilization Summary Report.
3. Statista: Psychotic Disorders - Saudi Arabia | Market Forecast.
4. PR Newswire: Jazz Pharmaceuticals Announces U.S. Commercial Availability Of Versacloz™ (clozapine, USP) Oral Suspension.
5. Versacloz.com: Versacloz® (clozapine, USP) Information for Healthcare Providers.