ZIPRASIDONE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for ziprasidone hydrochloride and what is the scope of patent protection?

Ziprasidone hydrochloride is the generic ingredient in two branded drugs marketed by Viatris, Apotex, Aurobindo Pharma, Chartwell Rx, Dr Reddys Labs Inc, Lupin Pharms, Macleods Pharms Ltd, Mylan, Sandoz Inc, Zydus Lifesciences, and Pfizer Inc, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for ziprasidone hydrochloride. Twenty-three suppliers are listed for this compound.

Summary for ZIPRASIDONE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	146
Patent Applications:	500
What excipients (inactive ingredients) are in ZIPRASIDONE HYDROCHLORIDE?	ZIPRASIDONE HYDROCHLORIDE excipients list
DailyMed Link:	ZIPRASIDONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for ZIPRASIDONE HYDROCHLORIDE

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

Sponsor	Phase
First Affiliated Hospital Xi'an Jiaotong University	N/A
Shanghai Mental Health Center	Phase 4
Shanghai Jiao Tong University School of Medicine	Phase 4

See all ZIPRASIDONE HYDROCHLORIDE clinical trials

Pharmacology for ZIPRASIDONE HYDROCHLORIDE

Drug Class

Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for ZIPRASIDONE HYDROCHLORIDE

N05AE	Indole derivatives
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for ZIPRASIDONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GEODON	Capsules	ziprasidone hydrochloride	20 mg, 40 mg, 60 mg and 80 mg	020825	5	2005-02-07

US Patents and Regulatory Information for ZIPRASIDONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	ZIPRASIDONE HYDROCHLORIDE	ziprasidone hydrochloride	CAPSULE;ORAL	090348-003	Sep 5, 2012	AB	RX	No	No
Chartwell Rx	ZIPRASIDONE HYDROCHLORIDE	ziprasidone hydrochloride	CAPSULE;ORAL	090348-002	Sep 5, 2012	AB	RX	No	No
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-004	Feb 5, 2001	AB	RX	Yes	No

Expired US Patents for ZIPRASIDONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-003	Feb 5, 2001	5,312,925
Pfizer Inc	GEODON	ziprasidone hydrochloride	SUSPENSION;ORAL	021483-001	Mar 29, 2006	4,831,031
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-004	Feb 5, 2001	5,312,925

ZIPRASIDONE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ziprasidone Hydrochloride

Market Overview

The global ziprasidone hydrochloride market is experiencing significant growth, driven by several key factors. As of 2023, the market size was valued at USD 100 billion and is projected to reach USD 147.75 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5% from 2024 to 2031[1].

Key Drivers of the Market

Increasing Prevalence of Mental Health Disorders

The rising rates of bipolar disorder and schizophrenia are major drivers of the ziprasidone hydrochloride market. These conditions require effective and safe therapeutic options, and ziprasidone hydrochloride has emerged as a preferred choice due to its efficacy in managing psychotic symptoms and mood fluctuations[1][4].

Favorable Safety Profile

Ziprasidone hydrochloride is well-liked by medical professionals due to its superior safety profile, which includes a lower risk of weight gain and metabolic abnormalities compared to other antipsychotic medications. This reduces the long-term health risks associated with antipsychotic treatment, making it a more attractive option for patients and healthcare providers[1][3].

Expanding Treatment Options

The availability of ziprasidone hydrochloride in various forms, including capsules, tablets, injectable solutions, and powder, provides flexible treatment options. This versatility aligns with the trend toward deinstitutionalization and community-based mental health care, where patients often receive treatment outside traditional inpatient settings[1][3].

Ongoing Research and Development

Continuous research into the neuroprotective qualities and novel applications of ziprasidone hydrochloride is further boosting its market. Pharmaceutical companies' investments in research and development are expected to provide patients with more treatment alternatives and enhance their quality of life[1].

Patent Expirations and Cost Considerations

The expiration of patents on current antipsychotic medications is prompting medical professionals to seek more affordable alternatives, such as ziprasidone hydrochloride. This shift is driven by the need for cost-effective treatments without compromising on efficacy and safety[1].

Market Segmentation

By Type

The ziprasidone hydrochloride market is segmented by type into capsules, tablets, injectable solutions, and powder. Each form has its own market share and growth prospects, with the injectable form being particularly significant for acute agitation management and emergency situations[1].

By Application

The market is also segmented by application, including schizophrenia treatment, bipolar disorder treatment, depression adjunct, acute agitation management, clinical research, and hospital use. The treatment of schizophrenia and bipolar disorder remains the primary application, driving the majority of the market growth[1].

Geographical Regions

The market is analyzed across various geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own growth trajectory, influenced by local healthcare policies, awareness of mental health, and economic factors[1].

Financial Trajectory

Market Size and Projections

The ziprasidone hydrochloride market is expected to grow significantly, with a projected market size of USD 147.75 billion by 2031. This growth is driven by the increasing demand for effective and safe antipsychotic medications, as well as the expanding use of ziprasidone hydrochloride in various therapeutic applications[1].

Revenue Growth

The revenue growth for the ziprasidone hydrochloride market is anticipated to be robust, driven by the rising cases of mental health disorders and the preference for ziprasidone hydrochloride over other antipsychotic medications. The market is expected to register a rapid revenue CAGR over the forecast period[4].

Investment and Funding

Pharmaceutical companies are investing heavily in research and development to enhance the efficacy and safety of ziprasidone hydrochloride. This investment is expected to yield more treatment alternatives and improve patient outcomes, further driving market growth[1].

Competitive Landscape

The market is competitive, with several key players such as Pfizer, Apotex, Aurobindo Pharma, Teva Pharmaceuticals, and others. The competitive landscape is characterized by new service/product launches, collaborations, company expansions, and acquisitions, which are crucial for understanding the market dynamics and strategies employed by top companies[1].

Regulatory and Economic Factors

Regulatory Approvals

Setting up a ziprasidone hydrochloride manufacturing plant involves navigating through various regulatory procedures and approvals. These include compliance with quality assurance criteria, technical tests, and certifications required for the production and distribution of pharmaceuticals[3].

Economic Analysis

The economic analysis of setting up a ziprasidone hydrochloride manufacturing plant includes capital expenditure, operating expenditure, income projections, taxation, depreciation, and liquidity analysis. The report also covers profitability analysis, payback period, Net Present Value (NPV), and sensitivity analysis to provide a comprehensive understanding of the project economics[3].

Patient and Healthcare Provider Preferences

Efficacy and Tolerability

Ziprasidone hydrochloride is preferred by patients and healthcare providers due to its efficacy in managing psychotic symptoms and mood fluctuations with minimal sedative effects. This allows individuals to maintain better cognitive and functional abilities during treatment[3][4].

Side Effect Profile

The medication's relatively favorable side effect profile, with lower risks of weight gain and metabolic disturbances, is another key factor driving its preference. This makes it a safer long-term treatment option compared to other antipsychotic medications[1][3].

Conclusion

The ziprasidone hydrochloride market is poised for significant growth driven by increasing demand for effective and safe antipsychotic medications, expanding treatment options, and ongoing research and development. The market's financial trajectory is robust, with a projected market size of USD 147.75 billion by 2031. Key drivers include the rising prevalence of mental health disorders, a favorable safety profile, and the availability of the medication in various forms.

Key Takeaways

• The ziprasidone hydrochloride market is expected to grow from USD 100 billion in 2023 to USD 147.75 billion by 2031.
• The market is driven by the increasing prevalence of bipolar disorder and schizophrenia.
• Ziprasidone hydrochloride has a favorable safety profile with lower risks of weight gain and metabolic disturbances.
• The medication is available in various forms, including capsules, tablets, injectable solutions, and powder.
• Pharmaceutical companies' investments in research and development are expected to enhance treatment alternatives and patient outcomes.
• Regulatory approvals and economic factors play a crucial role in the setup and operation of manufacturing plants.

FAQs

Q: What is the projected market size of ziprasidone hydrochloride by 2031?

A: The ziprasidone hydrochloride market is expected to reach USD 147.75 billion by 2031[1].

Q: What are the primary drivers of the ziprasidone hydrochloride market?

A: The primary drivers include the increasing prevalence of bipolar disorder and schizophrenia, a favorable safety profile, and the availability of the medication in various forms[1][3].

Q: In what forms is ziprasidone hydrochloride available?

A: Ziprasidone hydrochloride is available in capsules, tablets, injectable solutions, and powder[1].

Q: Why is ziprasidone hydrochloride preferred over other antipsychotic medications?

A: Ziprasidone hydrochloride is preferred due to its efficacy in managing psychotic symptoms and mood fluctuations with minimal sedative effects and a relatively favorable side effect profile[3][4].

Q: What are the key regulatory considerations for setting up a ziprasidone hydrochloride manufacturing plant?

A: Setting up a manufacturing plant involves compliance with quality assurance criteria, technical tests, and certifications required for the production and distribution of pharmaceuticals[3].

Sources

1. Market Research Intellect: "Global Ziprasidone Hydrochloride Market Size and Projections"
2. FDA: "GEODON Capsules and GEODON for Injection"
3. IMARC Group: "Ziprasidone (Geodon) Manufacturing Plant Project Report 2024"
4. Reports and Data: "Global Ziprasidone Market – Forecast to 2030"