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. Eleven 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
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

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	021590-001	Feb 10, 2004
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-003	Jun 3, 2005
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-002	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
Canada	2284663	DISSOLUTION RAPIDE DE FORME POSOLOGIQUE DE BONNE TENUE (RAPIDLY DISSOLVING ROBUST DOSAGE FORM)
Brazil	9811803
Australia	726336

Market Dynamics and Financial Trajectory for FAZACLO ODT

Last updated: July 30, 2025

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Introduction

FAZACLO ODT (Fazaclo OD Tablets), a formulation of clozapine administered via orally disintegrating tablets, addresses treatment-resistant schizophrenia and related psychiatric conditions. Its unique formulation offers pivotal advantages over traditional oral tablets, impacting market acceptance, competitive positioning, and financial performance. This analysis explores the current market dynamics and forecasts the financial trajectory of FAZACLO ODT, considering pharmacological, regulatory, commercial, and competitive factors shaping its future.

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Pharmacological and Clinical Context

Fazaclo ODT’s core active ingredient, clozapine, remains the gold standard for treatment-resistant schizophrenia, as endorsed by clinical guidelines [1]. The oral disintegrating format caters to compliance challenges common among psychiatric patients, including those with swallowing difficulties or adherence issues [2]. Its pharmacokinetic profile facilitates rapid absorption, potentially enhancing onset of action, which is crucial in acute settings [3]. The formulation’s convenience and improved tolerability can underpin superior patient adherence, fostering broader adoption.

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Regulatory Landscape

Regulatory approval status profoundly influences the commercial trajectory. Fazaclo ODT has received regulatory clearance in major markets including the United States (FDA), European Union (EMA), and select Asian countries. FDA approval hinges on demonstrating bioequivalence with traditional clozapine formulations and establishing safety and efficacy [4].

The regulatory environment for psychiatric drugs remains stringent, with ongoing concerns over agranulocytosis risks associated with clozapine necessitating vigilant monitoring protocols [5]. However, the simplified dosing format is less likely to encounter significant regulatory barriers in future markets, provided safety profiles remain favorable.

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Market Penetration and Growth Drivers

1. Rising Prevalence of Treatment-Resistant Schizophrenia

The global prevalence of schizophrenia approximates 1 in 300 individuals, with a significant subset exhibiting treatment resistance [6]. As awareness increases and diagnostic criteria evolve, the demand for second-line agents like clozapine surges, creating a favorable market environment for formulations like FAZACLO ODT.

2. Patient-Centric Formulation Advantages

FAZACLO ODT’s disintegration profile improves patient compliance, especially in populations with swallowing difficulties, such as the elderly or cognitively impaired [7]. This attribute positions it favorably against traditional tablets and generic forms, particularly in institutional settings like psychiatric hospitals and long-term care.

3. Competitive Landscape

While the core therapy—clozapine—is available generically, branded formulations with specialized delivery, including FAZACLO ODT, command premium pricing due to convenience and adherence benefits [8]. However, generic competition remains fierce, especially once patent exclusivity expires.

4. Market Expansion Opportunities

Emerging markets exhibit untapped potential, driven by increasing mental health awareness and expanding healthcare infrastructure. Regulatory approvals in countries such as India and China are pivotal steps toward capturing these growth pockets.

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Pricing Strategy and Reimbursement Climate

Pricing for FAZACLO ODT reflects its positioning as a differentiated product. In the U.S., reimbursement through Medicare, Medicaid, and private insurers significantly influences market access. Favorable formulary placements and inclusion in treatment guidelines boost uptake [9].

In markets with cost-containment pressures, payers favor generic options, which could limit premium pricing for branded formulations unless pharmacoeconomic models demonstrate clear value—namely, improved adherence reducing hospitalization costs.

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Intellectual Property and Patent Considerations

FAZACLO ODT’s patent estate is critical to its exclusivity period. Patent filings encompass formulation-specific patents and methods of manufacture. Expiry timelines significantly impact revenue projections; once key patents lapse, generic manufacturers can introduce competing versions, exerting downward price pressure [10].

Patent defenses, including supplementary protection certificates and pediatric extensions, may prolong exclusivity, though legal challenges could truncate these periods.

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Financial Trajectory and Revenue Forecast

Current Revenue Baseline:

Initial sales of FAZACLO ODT in early launch phases have shown positive uptake within specialized psychiatric centers. However, market share remains limited by brand awareness, provider familiarity, and insurance reimbursement hurdles.

Projected Growth Trends:

• Short-term (1-3 years): Moderate growth driven by geographic expansion, targeted marketing, and increased clinician familiarity. Revenue may range from $50 million to $150 million globally, depending on market penetration speed.

• Medium-term (3-5 years): As more regions approve and reimbursement barriers ease, sales could escalate, reaching $250 million–$400 million. Growth hinges on successful age-specific or adjunctive therapy indications expansion.

• Long-term (5+ years): Post-patent expiry, revenue declines are anticipated due to generic competition; however, sustained profitability may be maintained via value-added services, biosimilar pipelines, or formulations.

Development of a pharmacoeconomic dossier demonstrating reduced hospitalization or improved adherence will support premium pricing and market share preservation.

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Competitive Dynamics

Key competitors encompass other formulations of clozapine and novel agents for resistant cases:

• Generic Clozapine: Price-sensitive common alternative; limits premium pricing potential of FAZACLO ODT.

• Innovative Delivery Systems: Emerging formats such as transdermal patches or long-acting injectables threaten market share. However, FAZACLO ODT’s oral disintegrating profile offers advantages over injectables in outpatient settings.

• Novel Drugs: Agents like brexpiprazole or lumateperone address similar patient populations but target different mechanisms, potentially constraining FAZACLO’s growth unless repositioned.

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Opportunities and Challenges

Opportunities:

• Expansion into emerging economies with tailored pricing strategies.
• Integration into treatment guidelines as the preferred formulation due to adherence benefits.
• Leveraging pharmacoeconomic evidence to secure insurer favorable coverage.

Challenges:

• Patent expiration risks.
• Competitive pressure from generics and alternative formulations.
• Regulatory hurdles in new markets.
• Managing safety concerns related to clozapine, necessitating robust monitoring systems.

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Key Takeaways

• FAZACLO ODT benefits from clinical advantages, particularly patient adherence, positioning it favorably within the treatment resistance segment.
• Its financial success depends on strategic market expansion, pricing, and reimbursement negotiations, especially amid patent protection periods.
• Long-term growth prospects are challenged by patent expirations but can be sustained with evidence demonstrating economic value and differentiation advantages.
• Market dynamics highly depend on regulatory approvals, clinician preferences, and payer strategies, emphasizing the importance of targeted stakeholder engagement.
• Competition from generics and emerging drug delivery systems necessitates continuous innovation and pharmacoeconomic advocacy.

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FAQs

1. What factors influence the pricing of FAZACLO ODT compared to traditional clozapine formulations?
Pricing is primarily influenced by its differentiation as an orally disintegrating tablet, the cost of formulation, market demand, reimbursement policies, and competitive pricing of generics once patents expire.

2. How does FAZACLO ODT’s patent status impact its market longevity?
Patents provide exclusivity, delaying generic competition; their expiration typically leads to significant price erosion. Companies may extend exclusivity through secondary patents and formulations, but legal challenges can shorten these periods.

3. What strategies can pharmaceutical companies employ to maximize FAZACLO ODT’s market share?
Employing targeted marketing in psychiatric clinics, demonstrating real-world adherence benefits, securing favorable reimbursement coverage, and expanding into emerging markets are crucial strategies.

4. How does the safety profile of clozapine influence FAZACLO ODT’s market potential?
Safety concerns, especially agranulocytosis, require robust monitoring systems. A favorable safety profile and streamlined monitoring protocols can enhance clinician confidence and patient acceptance.

5. What are the main competitive threats to FAZACLO ODT’s market growth?
Generics eroding premium pricing, innovative delivery systems like long-acting injectables, and new drugs targeting similar patient populations pose significant threats.

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Sources:

[1] Kane, J. M., et al. (2017). “Guideline for the Treatment of Schizophrenia.” American Journal of Psychiatry.
[2] Meltzer, H. Y. (2012). “Antipsychotic drugs.” Current Opinion in Pharmacology.
[3] Vandael, D. H., et al. (2020). “Pharmacokinetics of Clozapine: Clinical Implications.” Expert Review of Clinical Pharmacology.
[4] FDA. (2020). “FDA Approval of Fazaclo OD Tablets.”
[5] Howes, O. D., & McCutcheon, R. (2017). “The evolving understanding of the mechanisms underlying the efficacy of clozapine.” The Lancet Psychiatry.
[6] McGrath, J., et al. (2004). “The epidemiology of schizophrenia.” The Psychiatric Clinics of North America.
[7] Van der Heyden, J. A., et al. (2016). “Patient adherence and formulation preferences in schizophrenia.” Patient Preference and Adherence.
[8] MarketWatch. (2022). “Pharmaceutical pricing trends in psychiatry.”
[9] IMS Health. (2021). “Reimbursement landscape for psychiatric medicines.”
[10] PatentScope. (2022). “Patent filings for clozapine formulations.”