FAZACLO ODT Drug Patent Profile

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

Fazaclo Odt is a drug marketed by Jazz and is included in one NDA.

The generic ingredient in FAZACLO ODT 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 Fazaclo Odt

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

Summary for FAZACLO ODT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	132
Clinical Trials:	3
Patent Applications:	5,220
Drug Prices:	Drug price information for FAZACLO ODT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FAZACLO ODT
DailyMed Link:	FAZACLO ODT at DailyMed

See drug prices for FAZACLO ODT

Recent Clinical Trials for FAZACLO ODT

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

Sponsor	Phase
University of British Columbia	Phase 4
Manhattan Psychiatric Center	Phase 4
Azur Pharma, Inc	Phase 4

See all FAZACLO ODT clinical trials

Paragraph IV (Patent) Challenges for FAZACLO ODT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FAZACLO ODT	Orally Disintegrating Tablets	clozapine	200 mg	021590	1	2011-04-18
FAZACLO ODT	Orally Disintegrating Tablets	clozapine	150 mg	021590	1	2011-04-08
FAZACLO ODT	Orally Disintegrating Tablets	clozapine	12.5 mg	021590	1	2008-06-05
FAZACLO ODT	Orally Disintegrating Tablets	clozapine	25 mg and 100 mg	021590	1	2008-04-28

US Patents and Regulatory Information for FAZACLO ODT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-004	May 30, 2007		DISCN	Yes	No
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-002	Feb 10, 2004		DISCN	Yes	No
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-001	Feb 10, 2004		DISCN	Yes	No
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-003	Jun 3, 2005		DISCN	No	No
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-006	Jul 9, 2010		DISCN	Yes	No

Expired US Patents for FAZACLO ODT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-003	Jun 3, 2005
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-005	Jul 9, 2010
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-006	Jul 9, 2010
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-002	Feb 10, 2004
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-001	Feb 10, 2004

International Patents for FAZACLO ODT

See the table below for patents covering FAZACLO ODT around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	3412694
Turkey	200000139
Portugal	1003484
Japan	2003231629	FOAMABLE DOSAGE FORM
Canada	2061917	FORME POSOLOGIQUE EFFERVESCENTE POUR ENFANTS (PEDIATRIC EFFERVESCENT DOSAGE FORM)

FAZACLO ODT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of FAZACLO ODT (Clozapine)

Introduction to FAZACLO ODT

FAZACLO ODT, a brand name for the orally disintegrating tablet (ODT) formulation of clozapine, is a medication primarily used to treat schizophrenia and other severe mental health disorders. Understanding the market dynamics and financial trajectory of this drug is crucial for stakeholders, including pharmaceutical companies, healthcare providers, and investors.

Global Clozapine Market Overview

The global clozapine market, which includes FAZACLO ODT, is characterized by several key factors:

• Market Size and Growth: The global clozapine market was valued at USD 341.4 million in 2021 and is projected to reach USD 525.78 million by 2031, exhibiting a Compound Annual Growth Rate (CAGR) of 4.5% during this period[4].
• Segmentation: The market can be segmented based on indication (schizophrenia disorder, unipolar depression, bipolar disorder, dementia, etc.), form (tablet and liquid), and end-user (hospitals, clinics, ambulatory surgical centers, pharmacies, etc.)[1].

Key Drivers of the Market

Several factors are driving the growth of the clozapine market:

• Rising Cases of Schizophrenia and Related Disorders: The increasing prevalence of schizophrenia and other mental health disorders is a primary driver. Genetic mutations and physical illnesses leading to depression and substance-induced psychoses also contribute to this trend[1].
• Research and Development: Significant investments in research and development activities, including the introduction of novel clozapine moieties, are fueling market growth[1].
• Therapeutic Expansion: Initiatives by key market players to expand the therapeutic applications of clozapine are expected to offer lucrative opportunities during the forecast period[1].

Regional Market Dynamics

• North America: This region is projected to capture a major share of the global clozapine market. The high prevalence of mental health disorders, such as depression and schizophrenia, in the U.S. and other North American countries drives this demand[1].
• Asia Pacific: This region is anticipated to account for the second-largest share of the global clozapine market. Increasing social awareness about mental disorders and the growing reach of therapeutics in this region are key factors[1].

Financial Trajectory

The financial performance of the clozapine market, including FAZACLO ODT, can be analyzed through several metrics:

• Market Value: The market is expected to grow from USD 341.4 million in 2021 to USD 525.78 million by 2031, indicating a steady financial growth trajectory[4].
• Revenue Distribution: The revenue is distributed across various end-users, with hospitals, clinics, and pharmacies being significant contributors. The average monthly costs and claim counts for mental health drugs, including clozapine, provide insights into the financial utilization patterns[3].

Key Players and Market Fragmentation

The global clozapine market is highly fragmented, with several key players holding significant market shares:

• Major Players: Companies such as Novartis, Cambrex, Arevipharma, Medichem, and others are major players in the market. Additionally, companies like Mylan, HLS, Jazz Pharmaceuticals, and Teva Pharmaceuticals are also prominent in the clozapine market[1][4].

Challenges and Restraints

Despite the growth drivers, the clozapine market faces several challenges:

• Side Effects: Clozapine is associated with side effects such as dry mouth, insomnia, blurred vision, drowsiness, and the risk of drug addiction. These side effects can have a harmful impact on patient health and may restrain market growth[1].
• Regulatory and Safety Concerns: The need for strict monitoring due to the risk of agranulocytosis and other adverse effects adds to the regulatory and safety concerns, which can impact market dynamics[5].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the clozapine market. While there has been an increased focus on mental health due to the pandemic, supply chain disruptions and changes in healthcare priorities have also affected the market. However, the overall demand for clozapine has remained relatively stable due to its essential nature in treating severe mental health conditions[1].

Future Outlook

The future outlook for the clozapine market, including FAZACLO ODT, is positive due to the increasing prevalence of mental health disorders and ongoing research and development efforts. However, addressing the side effects and regulatory challenges will be crucial for sustained growth.

Key Takeaways

• The global clozapine market is growing, driven by rising cases of schizophrenia and related disorders.
• North America and Asia Pacific are key regions driving market growth.
• Significant investments in R&D and therapeutic expansion are fueling the market.
• Side effects and regulatory concerns are major restraints.
• The market is highly fragmented with several key players.

Frequently Asked Questions

Q: What is the expected market size of the global clozapine market by 2031? A: The global clozapine market is expected to reach USD 525.78 million by 2031[4].

Q: What is the CAGR of the clozapine market from 2023 to 2031? A: The clozapine market is expected to exhibit a CAGR of 4.3% during this period[4].

Q: Which region is projected to capture the major share of the global clozapine market? A: North America is projected to capture a major share of the global clozapine market[1].

Q: What are the primary side effects of clozapine that could restrain market growth? A: The primary side effects include dry mouth, insomnia, blurred vision, drowsiness, and the risk of drug addiction[1].

Q: Who are some of the major players operating in the global clozapine market? A: Major players include Novartis, Cambrex, Arevipharma, Medichem, Mylan, HLS, Jazz Pharmaceuticals, and Teva Pharmaceuticals[1][4].

Sources

1. BioSpace: Clozapine Market: Rising cases of Schizophrenia and its related disorders to drive the market.
2. State of Indiana Medicaid DUR Annual Report: FAZACLO 200MG ODT.
3. Oregon Drug Use Review / Pharmacy & Therapeutics Committee: Meeting Docs.
4. Business Research Insights: Clozapine Market Size - 2031 Report.
5. New York State Medicaid Drug Utilization Review (DUR) Board: Meeting Summary.