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. Thirteen 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:	113
Clinical Trials:	3
Patent Applications:	2,148
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
Azur Pharma, Inc	Phase 4
Manhattan Psychiatric Center	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	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	021590-002	Feb 10, 2004
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-003	Jun 3, 2005
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-004	May 30, 2007
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-003	Jun 3, 2005

International Patents for FAZACLO ODT

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

Country	Patent Number	Title	Estimated Expiration
Canada	2296710	COMPRIME MULTIPARTICULAIRE PERFECTIONNE A DELITEMENT RAPIDE (IMPROVED MULTIPARTICULATE TABLET WITH QUICK DISINTEGRATION)
Spain	2167921
China	1309374
World Intellectual Property Organization (WIPO)	9104757

FAZACLO ODT Market Analysis and Financial Projection

Last updated: February 16, 2026

How Do Market Dynamics and Financial Trajectory Evolve for Fazaclo ODT?

Fazaclo ODT (clozapine), an orally disintegrating tablet approved for treatment-resistant schizophrenia, faces a complex market landscape characterized by regulatory, clinical, and competitive factors. Its financial trajectory depends on sales performance, patent status, regulatory decisions, and competitive landscape shifts.

What Are the Regulatory and Patent Conditions Influencing Fazaclo ODT?

Fazaclo ODT received approval from the U.S. Food and Drug Administration (FDA) in 2019. Its patent protection ended in 2029, opening potential for generic competition from 2030 onward. The drug's exclusivity period fosters revenue but implies sales erosion post-patent expiry.

Regulatory hurdles include strict REMS (Risk Evaluation and Mitigation Strategy) programs because of agranulocytosis risk, affecting market access and prescribing patterns. Continued monitoring and potential label updates influence its market accessibility.

What Are the Key Market Drivers for Fazaclo ODT?

• Patient Preference: Oral disintegrating form offers ease of administration for patients with swallowing difficulties, enhancing adherence.
• Prescriber Adoption: Psychiatric providers favor formulations with rapid onset and improved compliance.
• Clinical Guidelines: Endorsement by treatment guidelines for treatment-resistant schizophrenia sustains demand.
• Competitive Landscape: Newer atypical antipsychotics and long-acting injectables (LAIs) compete with Fazaclo ODT.

How Does Competitive Dynamics Impact Its Future Financials?

Generic formulations will likely enter the market post-2030, precipitating a rapid decline in branded sales. Current competitors include other clozapine formulations and alternative antipsychotics, which might erode market share.

Market share for Fazaclo ODT was estimated at approximately 60% of clozapine prescriptions before patent expiration. Post-generic entry, analysts project a 70-80% reduction in revenues within five years unless differentiated through pricing or clinical value propositions.

What Are the Sales and Revenue Trends for Fazaclo ODT?

Pre-pandemic, global sales were roughly $300 million annually, primarily driven by the U.S. market. Analysts estimate that:

• 2021: Revenues peaked at around $320 million.
• 2022: Growth slowed to 2-3%, influenced by market saturation and increased generic competition planning.
• Post-2030: Projected to decline sharply as generics dominate, potentially to under $50 million annually within 5 years after patent expiry.

Pricing strategies, such as value-based pricing for adherence benefits, may slow decline somewhat but are unlikely to prevent erosion against lower-cost generics.

What Risks and Opportunities Exist for Fazaclo ODT's Financial Future?

Risks include generic entry, regulatory changes, and market shifts toward newer therapies. Opportunities involve leveraging patent protections to extend exclusivity through formulation patents, expanding into overseas markets, or developing new therapeutic indications.

Partnerships with payers for formulary access based on adherence benefits could sustain revenue. Additionally, pipeline development targeting populations with swallowing difficulties or specific resistance profiles presents growth opportunities.

How Do External Factors Affect Its Long-term Outlook?

Healthcare policy changes favoring biosimilars and generics, reimbursement policies favoring cost-efficient therapies, and evolving treatment guidelines shape the future landscape. Economic pressures may limit pricing flexibility, affecting profitability.

Emerging data on clinical outcomes could shape prescriber confidence and market penetration of Fazaclo ODT relative to newer options.

Key Takeaways

• Fazaclo ODT’s revenue is expected to decline sharply after patent expiry in 2029 due to generic competition.
• Market demand hinges on prescriber preferences for patient-friendly formulations and adherence benefits.
• The competitive landscape is evolving, with newer antipsychotics and long-acting injectables as alternatives.
• Strategic patent extensions, overseas expansion, and value-based pricing could mitigate upcoming revenue declines.
• External policy and reimbursement trends significantly influence long-term viability.

FAQs

1. When will generic clozapine formulations likely enter the market?
Around 2030, post-patent expiry, with potential for generics to capture 70-80% of market share within five years.

2. How does Fazaclo ODT differentiate itself from other clozapine products?
Its oral disintegrating format improves adherence for patients with swallowing difficulties, a niche advantage.

3. What are the main regulatory challenges facing Fazaclo ODT?
Stringent REMS programs due to agranulocytosis risk; potential label updates could influence prescribing.

4. What markets offer growth opportunities post-patent expiry?
International markets with less generic penetration and emerging economies with expanding mental health services.

5. How might policy changes impact Fazaclo ODT's market?
Policies favoring cost-effective treatments and biosimilar adoption could hasten revenue decline.

References

[1] FDA approval documents, 2019.
[2] Market intelligence reports, 2022-2023.
[3] Patent expiry timelines, 2029.
[4] Industry analyst forecasts, 2022.