CLOZAPINE - Generic Drug Details

What are the generic drug sources for clozapine and what is the scope of freedom to operate?

Clozapine is the generic ingredient in four branded drugs marketed by Tasman Pharma, Barr Labs Inc, Mylan, Jazz, Accord Hlthcare, Aurobindo Pharma, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Par Pharm, Sandoz, Sun Pharm Inds Inc, Zydus Pharms, and Heritage Life, and is included in fifteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Clozapine has six patent family members in six countries.

There are thirteen drug master file entries for clozapine. Twelve suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for CLOZAPINE

International Patents:	6
US Patents:	1
Tradenames:	4
Applicants:	13
NDAs:	15
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	183
Drug Prices:	Drug price trends for CLOZAPINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLOZAPINE
What excipients (inactive ingredients) are in CLOZAPINE?	CLOZAPINE excipients list
DailyMed Link:	CLOZAPINE at DailyMed

See drug prices for CLOZAPINE

Recent Clinical Trials for CLOZAPINE

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

Sponsor	Phase
Intra-Cellular Therapies, Inc.	Phase 4
Dr. Inge Winter	Phase 4
Westfälische Wilhelms-Universität Münster	Phase 4

See all CLOZAPINE clinical trials

Generic filers with tentative approvals for CLOZAPINE

Applicant	Application No.	Strength	Dosage Form
		200MG	TABLET, ORALLY DISINTEGRATING;ORAL
		150MG	TABLET, ORALLY DISINTEGRATING;ORAL
		100MG	TABLET, ORALLY DISINTEGRATING;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for CLOZAPINE

Drug Class

Atypical Antipsychotic

Medical Subject Heading (MeSH) Categories for CLOZAPINE

Antipsychotic Agents

GABA Antagonists

Serotonin Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for CLOZAPINE

N05AH	Diazepines, oxazepines, thiazepines and oxepines
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for CLOZAPINE

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 CLOZAPINE

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	021590-005	Jul 9, 2010		DISCN	Yes	No
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-002	Feb 10, 2004		DISCN	Yes	No
Barr Labs Inc	CLOZAPINE	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	090308-002	Nov 25, 2015	AB	RX	No	Yes

Expired US Patents for CLOZAPINE

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

International Patents for CLOZAPINE

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

CLOZAPINE Market Analysis and Financial Projection Experimental

Clozapine Market Dynamics and Financial Trajectory: A Comprehensive Overview

Introduction to Clozapine

Clozapine is a potent antipsychotic medication primarily used in the management of treatment-resistant schizophrenia. Its unique efficacy profile and safety monitoring requirements make it a crucial option for patients who do not respond to traditional antipsychotic treatments.

Market Size and Growth Projections

The global clozapine market is anticipated to experience significant growth over the forecast period from 2024 to 2032. Here are some key financial projections:

• Current Market Size: The global clozapine market was valued at approximately USD 365.3 million in 2024 and is expected to reach USD 470.3 million by 2032, growing at a CAGR of 4.3% during this period[1][2].
• Alternative Projections: Another report suggests that the clozapine market size was USD 500 million in 2023 and is projected to reach USD 1071.8 million by 2031, with a higher CAGR of 10% from 2024 to 2031[4].

Key Drivers of the Market

Several factors are driving the growth of the clozapine market:

• Treatment-Resistant Schizophrenia: Clozapine's efficacy in treating schizophrenia that is resistant to other antipsychotics is a primary driver. Its use as a second-line therapy provides substantial therapeutic advantages for non-responsive patients[4].
• Regulatory Approvals and Availability: Regulatory clearances and the availability of clozapine in various regions contribute to its market growth. Patient advocacy programs also play a significant role in ensuring greater accessibility to this medication[4].
• Research and Development: Ongoing research aimed at minimizing side effects and optimizing treatment regimens further supports market expansion. Pharmaceutical companies' efforts to improve formulation and administration systems enhance patient compliance and treatment outcomes[4].

Market Segmentation

The clozapine market is segmented based on several criteria:

• Applications: The market is segmented into hospital, clinic, and other settings. The hospital segment is expected to grow at a significant CAGR during the forecast period[1].
• Types: Clozapine is available in various forms, including tablets and oral suspensions. The tablet segment is projected to maintain a significant share of the global market[1][2].
• Geographical Regions: The market is divided into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. These regions are expected to contribute differently to the overall market growth, with North America and Europe being key markets[1][4].

Leading Manufacturers

The global clozapine market is dominated by a few key players:

• Mylan, HLS, and Jazz Pharmaceuticals: These companies held about 52% of the market share in terms of revenue in 2018. Their strategic initiatives and market presence continue to influence the market dynamics[1].

Financial Performance and Projections

Here are some financial highlights and projections for the clozapine market:

• Revenue Share: The top three players in the market held a significant revenue share, indicating a concentrated market with strong competition among the leading manufacturers[1].
• CAGR: The market is expected to grow at a CAGR of 4.3% from 2024 to 2032, although some reports suggest a higher CAGR of 10% from 2024 to 2031[1][4].
• Market Value: By 2032, the market is projected to reach USD 470.3 million, and by 2031, it is expected to reach USD 1071.8 million, depending on the source and projection model[1][4].

Challenges and Side Effects

Despite its efficacy, clozapine is associated with significant side effects, particularly metabolic issues:

• Weight Gain and Metabolic Side Effects: Studies have shown that over half of young people commenced on clozapine experience clinically significant weight gain, along with increases in BMI, waist circumference, and blood pressure. These side effects necessitate careful monitoring and management[5].

Regulatory and Safety Monitoring

The use of clozapine is reinforced by regulatory bodies due to its distinct therapeutic benefits and safety monitoring criteria:

• Safety Monitoring: Clozapine requires regular monitoring for side effects such as agranulocytosis, which is a rare but serious condition. This monitoring is crucial for patient safety and compliance[4].

Conclusion

The clozapine market is poised for significant growth driven by its efficacy in treating treatment-resistant schizophrenia, ongoing research and development, and regulatory approvals. However, the market must also address the challenges associated with the drug's side effects.

Key Takeaways

• Market Growth: The clozapine market is expected to grow at a CAGR of 4.3% to 10% from 2024 to 2032/2031.
• Key Drivers: Treatment-resistant schizophrenia, regulatory approvals, and ongoing R&D are key drivers.
• Market Segmentation: The market is segmented by application, type, and geographical region.
• Leading Manufacturers: Mylan, HLS, and Jazz Pharmaceuticals are the leading players.
• Side Effects: Clozapine is associated with significant metabolic side effects, necessitating careful monitoring.

FAQs

Q: What is the expected market size of the clozapine market by 2032? A: The global clozapine market is expected to reach USD 470.3 million by 2032[1].

Q: What is the CAGR of the clozapine market from 2024 to 2032? A: The market is expected to exhibit a CAGR of 4.3% from 2024 to 2032[1].

Q: Which regions are leading the clozapine market? A: North America, Europe, and Asia-Pacific are among the leading regions in the clozapine market[1][4].

Q: What are the primary side effects associated with clozapine? A: Clozapine is associated with significant metabolic side effects, including weight gain, increased BMI, waist circumference, and blood pressure[5].

Q: Who are the leading manufacturers in the clozapine market? A: Mylan, HLS, and Jazz Pharmaceuticals are the leading manufacturers, holding about 52% of the market share in 2018[1].

Sources

1. Clozapine Market Demand Insights and the Future’s Fastest-Growing Sector in 2032 - 360 Research Reports
2. Clozapine Tablet Market Size - Forecast To 2032 - Business Research Insights
3. Clozapine Tablet Sales Market Size, Scope And Forecast Report - Market Research Intellect
4. Clozapine Market Size, Global Trends | Forecast 2024-2031 - Market Research Intellect
5. Physical health trajectories of young people commenced on clozapine - Cambridge University Press