You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

Clozapine - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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.

Drug Prices for clozapine

See drug prices for clozapine

Recent Clinical Trials for clozapine

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

SponsorPhase
Intra-Cellular Therapies, Inc.Phase 4
Westfälische Wilhelms-Universität MünsterPhase 4
Dr. Inge WinterPhase 4

See all clozapine clinical trials

Generic filers with tentative approvals for CLOZAPINE
Applicant Application No. Strength Dosage Form
⤷  Subscribe⤷  Subscribe200MGTABLET, ORALLY DISINTEGRATING;ORAL
⤷  Subscribe⤷  Subscribe150MGTABLET, ORALLY DISINTEGRATING;ORAL
⤷  Subscribe⤷  Subscribe100MGTABLET, 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
Medical Subject Heading (MeSH) Categories for clozapine
Anatomical Therapeutic Chemical (ATC) Classes for clozapine
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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-002 Feb 10, 2004 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Barr Labs Inc CLOZAPINE clozapine TABLET, ORALLY DISINTEGRATING;ORAL 090308-002 Nov 25, 2015 AB RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma CLOZAPINE clozapine TABLET;ORAL 206433-003 Nov 29, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

International Patents for clozapine

Country Patent Number Title Estimated Expiration
Canada 2532648 FORMULATION DE SUSPENSION STABLE DE CLOZAPINE (A STABLE CLOZAPINE SUSPENSION FORMULATION) ⤷  Subscribe
Australia 2004257556 A stable clozapine suspension formulation ⤷  Subscribe
Spain 2436213 ⤷  Subscribe
European Patent Office 1646393 FORMULATION DE SUSPENSION STABLE DE CLOZAPINE (A STABLE CLOZAPINE SUSPENSION FORMULATION) ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

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

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.